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Yale Psychiatry Grand Rounds: October 7, 2022

October 07, 2022

Yale Psychiatry Grand Rounds: October 7, 2022

 .
  • 00:00Thank you so much, Doctor.
  • 00:03Thank you so much Doctor O'Malley.
  • 00:04I really appreciate you inviting me to
  • 00:08this and to seeing all of you here,
  • 00:10and really excited to start spreading
  • 00:12the word even more about the
  • 00:15importance of implementation science.
  • 00:21So we all know this quote that on average
  • 00:25it takes 17 years for just 14% of original
  • 00:29research to make its way into practice.
  • 00:32And so this really shows that we
  • 00:34really don't have an evidence
  • 00:35problem when it comes to research,
  • 00:37but we have an implementation problem.
  • 00:39And this is where the field of implementation
  • 00:42science really comes into play,
  • 00:44that we really need to be
  • 00:46thinking and and training.
  • 00:48People to think about the relevance of their
  • 00:51research and the impulse impactful Ness
  • 00:53that they can have from a very early stage.
  • 00:56We really need to be working
  • 00:58with a range of stakeholders,
  • 01:00healthcare leaders, staff,
  • 01:01people in the Community,
  • 01:03patients and families in order
  • 01:05to break down this research to
  • 01:07practice gap and increase the public
  • 01:10health impact of our work.
  • 01:11And we also need to be thinking about
  • 01:14the different study designs that we
  • 01:16use in order to speed that development,
  • 01:18as doctor Melley mentioned,
  • 01:20so that we don't have to wait 17 years
  • 01:23and that we can have more than 14% of
  • 01:26the research make its way into routine care.
  • 01:30People have been spending a lot of
  • 01:32time thinking about why we waste
  • 01:34so much of our research funding
  • 01:36and they don't necessarily focus on
  • 01:38implementation science when they do this.
  • 01:40But some of the things that they
  • 01:43really highlight that we need to
  • 01:45be doing more of are very relevant
  • 01:47implementation science.
  • 01:48So in,
  • 01:49you know,
  • 01:50work that's been happening since 2009,
  • 01:53Chalmers and colleagues have been
  • 01:55focusing on this,
  • 01:56this number of 85% of waste in reporting.
  • 01:59The use of research evidence,
  • 02:01which I'm sure you've also heard about,
  • 02:03and it's just staggering because if you
  • 02:06look at numbers from 2010 where there
  • 02:09was $200 billion of research funding,
  • 02:11that means that about $170
  • 02:13billion never of research,
  • 02:16never really made it into publication,
  • 02:19into practice, into dissemination.
  • 02:21And so lots of people spend time thinking,
  • 02:24why is that?
  • 02:25And so they these are some of the questions
  • 02:28that they're saying that we need to.
  • 02:30To focus on more in our research,
  • 02:32you know,
  • 02:32are our research decisions that
  • 02:34we're making based on questions
  • 02:36that are relevant to users?
  • 02:38Are we using appropriate research designs,
  • 02:40methods and analysis?
  • 02:42If not,
  • 02:43really going to get into research
  • 02:45regulation and management here,
  • 02:46but that is certainly an issue.
  • 02:49Do we make our research findings
  • 02:52accessible and our our reports unbiased?
  • 02:55And importantly,
  • 02:56are they usable to the people who need them?
  • 02:59So I'm going to be thinking about.
  • 03:00These questions,
  • 03:01along with other things that are
  • 03:04related to implementation science
  • 03:05throughout this talk to really think
  • 03:08about how we can reduce this gap
  • 03:11from evidence into implementation.
  • 03:13I love this screenshot because it's
  • 03:15the editorial from the very first
  • 03:18issue of the journal implementation
  • 03:21Science back in 2006 by Martin Eccles
  • 03:24in the UK and Brian Mittman in the US.
  • 03:27I've been very fortunate to have
  • 03:29Brian as a mentor and implementation
  • 03:31science for the last 15 years.
  • 03:33And what I love about this is that
  • 03:35even though implementation science
  • 03:37had been around prior to 2006,
  • 03:39we didn't really have a
  • 03:40specific journal for it.
  • 03:41And so now, I mean you will
  • 03:43find implementation science
  • 03:44articles in many journals,
  • 03:45but this is considered our flagship.
  • 03:47And in this they defined what
  • 03:49implementation research is,
  • 03:50which is the scientific study of methods
  • 03:53to promote the systematic uptake of
  • 03:55research findings and other evidence
  • 03:57based practices into routine practice,
  • 03:59routine care and hence to improve the
  • 04:01quality and effectiveness of health services.
  • 04:04And care.
  • 04:04And so this is really where I'm
  • 04:07coming from when I talk to you
  • 04:09today about implementation science
  • 04:11and implementation research.
  • 04:13No one has ever told me these
  • 04:14are the three unique aspects
  • 04:16of implementation science,
  • 04:17but they are what I think are
  • 04:19the three unique aspects.
  • 04:20We have implementation strategies that
  • 04:22we've developed and I'll say more about
  • 04:25each of these throughout this talk.
  • 04:27We have these implementation strategies
  • 04:28that we need to use and test to make
  • 04:31sure that our evidence gets into practice.
  • 04:33We've developed our own type of study design,
  • 04:36which is this hybrid effectiveness
  • 04:38implementation trial design,
  • 04:40and we also really need to focus on
  • 04:42the pragmatic aspects of our research.
  • 04:45So first, the strategies.
  • 04:46This paper was a seminal paper from 2015
  • 04:50by Byron Powell and colleagues really.
  • 04:52And they used a modified
  • 04:54Delphi consensus approach.
  • 04:55I was one of many,
  • 04:57many people who participated in this
  • 04:59work to really think about what are
  • 05:02the strategies that we need to use
  • 05:04to get our research into practice,
  • 05:06and they define implementation
  • 05:08strategies as methods or techniques
  • 05:11used to enhance the adoption,
  • 05:13implementation and sustainability.
  • 05:14Of a clinical programmer practice,
  • 05:17they list 73 strategies in this
  • 05:19paper and that's very overwhelming.
  • 05:22And I would say that you know
  • 05:24this papers from 2015,
  • 05:25there are many more identified
  • 05:27and developed since then.
  • 05:29So I think it's really more helpful
  • 05:30to think about the buckets or
  • 05:32the categories of implementation
  • 05:33strategies that we can use.
  • 05:35And this is actually from an
  • 05:36earlier paper by the same group.
  • 05:38And so here are these nine buckets
  • 05:41of implementation strategies.
  • 05:42I would say that the ones I
  • 05:43use the most are bucket.
  • 05:453 adapting and tailoring to the context.
  • 05:48Bucket 4 developing
  • 05:50stakeholder relationships.
  • 05:52Bucket 5 training and educating stakeholders,
  • 05:56and six supporting clinicians.
  • 05:57We've also tried to do a little
  • 06:00bit around changing infrastructure.
  • 06:02That's a little bit harder,
  • 06:03but all of these are things that you can
  • 06:05think about when you're thinking about,
  • 06:07well, how?
  • 06:08What are the methods, techniques,
  • 06:09and tools I need to use,
  • 06:11identify, use, develop, and test?
  • 06:15To get evidence into practice.
  • 06:19And then our hybrid designs,
  • 06:20which are really just the
  • 06:22most important part,
  • 06:24I was one of the most important
  • 06:26parts of implementation science
  • 06:27that I would say and this is really
  • 06:29trying to help speed that that
  • 06:32evidence to implementation process.
  • 06:33So there are three types,
  • 06:35hybrid type one, Type 2 and Type 3.
  • 06:38And I'm going to make the argument
  • 06:40that any randomized control trial
  • 06:42needs to be a hybrid type one.
  • 06:44And I'll be saying that more and more,
  • 06:46but this is what we would
  • 06:47consider a traditional.
  • 06:48Randomized controlled trial of effectiveness.
  • 06:51But more and more people are
  • 06:52using this in efficacy too.
  • 06:53And I'll say more about that too.
  • 06:54But this is where we have our
  • 06:56primary goals of effectiveness.
  • 06:58And then we usually have our aim.
  • 06:59Three, to understand more about
  • 07:01the implementation context.
  • 07:03You know,
  • 07:03what is it that we are learning
  • 07:05about from this particular trial
  • 07:07that can help us move evidence
  • 07:10into practice sooner and apply that
  • 07:13information into the next study.
  • 07:15Hybrid Type 2 is when we have dual aims
  • 07:17of effectiveness and implementation.
  • 07:19Trying to understand it what not only
  • 07:21is our intervention effective but our
  • 07:24our implementation strategies effective.
  • 07:26And hybrid Type 3 is when we
  • 07:27flip things on their head.
  • 07:29And our primary aim is we know
  • 07:31that our intervention works.
  • 07:33We've tested this,
  • 07:34we know this,
  • 07:35we've tested it in multiple settings.
  • 07:36Now we need to know what are the
  • 07:38most effective strategies and so we
  • 07:40randomize on strategies and that's
  • 07:41really exciting and I'll I'll talk
  • 07:43about some work that we're doing there too.
  • 07:46And then the pragmatic aspect of our work,
  • 07:49you may already know about the
  • 07:52pragmatic explanatory continuum
  • 07:53indicator summary or the precise.
  • 07:54And this is the second version of it.
  • 07:56And these are the types of
  • 07:58things that we can think about.
  • 07:59All randomized controlled trials are on a
  • 08:03spectrum from explanatory to pragmatic.
  • 08:06the Super tight controlled efficacy trials,
  • 08:09especially things like drug trials,
  • 08:10they're going to be at the one
  • 08:13level here really controlled highly.
  • 08:15Restricted, very rigid and you know,
  • 08:18especially in the world of drug trials,
  • 08:20that's important.
  • 08:21But we're really talking about
  • 08:23behavioral interventions here.
  • 08:24And so these can be much more
  • 08:26pragmatic moving up the scale from
  • 08:28one to five in terms of what are
  • 08:30the outcomes that we're assessing.
  • 08:32We need to make sure that these are
  • 08:34relevant to the people involved.
  • 08:35You know,
  • 08:36if you are talking to your
  • 08:38stakeholders early,
  • 08:39you'll find out that maybe one
  • 08:40of the things that patients and
  • 08:41families want to know about is
  • 08:43like how can my loved one get back
  • 08:45to work or how can my loved one.
  • 08:46Have enough energy to play with their
  • 08:48grandchildren or something like that.
  • 08:50And so those aren't necessarily the things
  • 08:52that we assess in a in an efficacy trial,
  • 08:54but these are the things that
  • 08:55matter to the people who are
  • 08:57going to be using our research.
  • 08:58Eligibility is a big thing in our.
  • 09:03Try.
  • 09:06And. Controlled trial,
  • 09:09the expanded exclusive and often
  • 09:11we exclude the people who are going
  • 09:13to benefit most from our work
  • 09:15and that is really true in mental
  • 09:17health and substance use research.
  • 09:19And a pragmatic trial would say be more
  • 09:22inclusive, open it up to more people.
  • 09:24Those are the people that we're really
  • 09:25going to be able to affect in the
  • 09:27future and we need to know if our work,
  • 09:29if our research works for them now.
  • 09:31And that's part of the problem of
  • 09:33the research to of the evidence to
  • 09:35implementation gap is that we didn't
  • 09:37involve these people in the beginning.
  • 09:39We excluded them and then when we
  • 09:41move into Community settings we
  • 09:43find that it's not working for them.
  • 09:45And this gets to the setting piece,
  • 09:46where is the trial being done?
  • 09:48Often our work is being done
  • 09:49in hospital settings,
  • 09:50what we call the ivory tower,
  • 09:52and we're not reaching the people
  • 09:53for whom that is not the place
  • 09:55where they're getting their care.
  • 09:57And so again,
  • 09:58another push for talking to stakeholders,
  • 10:00moving our research out into
  • 10:02the Community faster,
  • 10:03doing more hybrid trials so that we
  • 10:05can understand how our intervention
  • 10:06is going to work in the place that
  • 10:09we want to eventually see it in.
  • 10:11And then the delivery and you know
  • 10:12and this is really hard when with
  • 10:15very highly protocolized renal
  • 10:16randomized controlled trials,
  • 10:17I understand.
  • 10:18But there are things that we can do to
  • 10:20think more about the flexible delivery
  • 10:21and I'm going to give you an example
  • 10:23of what we've done in one of those.
  • 10:26So recently people have been trying to
  • 10:29think about with what are the really
  • 10:31key things we need to be doing to
  • 10:33move evidence into implementation.
  • 10:35And this is a paper that I did with
  • 10:38colleagues Sarah Becker and Kelly Scott,
  • 10:40who were Brown and now at
  • 10:43Northwestern University,
  • 10:43where we really thought about what
  • 10:46are the guiding principles that
  • 10:48anyone should use in terms of moving
  • 10:51their research into implementation.
  • 10:53And so there we came up with
  • 10:55five guiding principles.
  • 10:56For that,
  • 10:56this paper just actually came
  • 10:58out a few days ago in print.
  • 11:00And then another paper that actually
  • 11:03Doctor O'Malley shared with me came
  • 11:05out in August in in Jamaica psychiatry
  • 11:08by Beth McGinty and Matthew Eisenberg.
  • 11:10Really thinking about exactly what
  • 11:12we're talking about here that we have.
  • 11:15We don't have an evidence problem.
  • 11:16We have an implementation problem.
  • 11:18And in this paper they talked about
  • 11:20four different strategies that
  • 11:22any researcher should use to to
  • 11:24address that implementation problem.
  • 11:26And that's so I've been thinking
  • 11:27about this for a while and I spend a
  • 11:30lot of time trying to build capacity
  • 11:32for implementation science among,
  • 11:34you know everyone from PhD students,
  • 11:36postdocs, early career,
  • 11:38up to full professors.
  • 11:39And even though I've been part of this work,
  • 11:42I really think when I compare like
  • 11:45what Doctor Becker's got and I
  • 11:47did and what Doctor McGinty and
  • 11:48Doctor Eisenberg did,
  • 11:49I really think that you can combine
  • 11:51them into 4 strategies to increase the
  • 11:54uptake of behavioral interventions and.
  • 11:56I would say that first of all when
  • 11:57I use the word strategies here,
  • 11:59I'm not talking about an implementation
  • 12:01strategy as we just mentioned,
  • 12:02but just what are the ways that we can
  • 12:05reduce the 17 year gap and what are
  • 12:08the ways that we can make research
  • 12:10less wasteful, more impactful.
  • 12:12And so I would say these strategies
  • 12:14are we need to conduct more hybrid
  • 12:17effectiveness implementation trials
  • 12:18and that was mentioned in our
  • 12:20paper and also the McKinsey paper
  • 12:23let's theory be your guide,
  • 12:25I always say to people.
  • 12:26Here is your friend Siri tells you exactly
  • 12:29what it is that you need to be addressing,
  • 12:31that you need to be measuring,
  • 12:33and can help you plan your work.
  • 12:34And we also talked about this in our paper.
  • 12:37You need to get to know your stakeholders
  • 12:39and that is just essential you.
  • 12:41I'm not an intervention developer,
  • 12:44treatment developer,
  • 12:44but I talked to people who are all
  • 12:47the time and I feel it at that stage.
  • 12:49We need to be talking to stakeholders.
  • 12:51Why develop something that
  • 12:52isn't going to work?
  • 12:53You can find that out from the beginning.
  • 12:55Even if you conducted a really strong,
  • 12:58highly controlled,
  • 12:58randomized controlled trial
  • 13:00and you did find effective or
  • 13:02efficacy for your intervention,
  • 13:03if it's not acceptable to people,
  • 13:05it's not going to make it into the.
  • 13:07Community based settings in which we
  • 13:09want it to and so involve stakeholders
  • 13:11right from the beginning and something
  • 13:13that is unique and wasn't mentioned
  • 13:15in those two previous papers that I
  • 13:17just talked to you about is I think
  • 13:19we really need to tell your tailor
  • 13:20our dissemination efforts more.
  • 13:22This is a big,
  • 13:24there are a lot of people who focus on this,
  • 13:25Ross Brownson at Washington
  • 13:27University in Saint Louis.
  • 13:28But I've been involved now in a quarry
  • 13:32project where we really are needing
  • 13:35to move our work out into wider.
  • 13:38Widespread use and this tailoring
  • 13:40is just really hit me over the
  • 13:44head with how essential this is.
  • 13:46And then of course I said 4
  • 13:48strategies in a month term and
  • 13:49you're going what is the mantra?
  • 13:50And so mantra is fun for me to think about.
  • 13:53I'm actually somebody who
  • 13:55studies mantram meditation.
  • 13:56And mantram in that context is
  • 13:59usually a spiritual word or phrase
  • 14:01that has a spiritual meaning or a
  • 14:04higher level meaning and can help
  • 14:07us bring focused attention to what
  • 14:09it is that we need to be working on.
  • 14:11It can help us also block out the noise.
  • 14:14It can bring awareness to the issue and.
  • 14:17A slow down and process and and so
  • 14:19you'll see why I've been interested
  • 14:20in this in the in the mental
  • 14:22health space in a minute.
  • 14:24But here I think the mantra now is
  • 14:27that we really need to integrate
  • 14:30HealthEquity with implementation science.
  • 14:33This is not a new thing.
  • 14:35It's quite a long you know a call
  • 14:38to action that is long overdue.
  • 14:40But you know we are now seeing
  • 14:42more and more implementation
  • 14:44scientists and more and more funding.
  • 14:47Opportunities really focusing
  • 14:48on how not only are we going to
  • 14:51bring our evidence into practice,
  • 14:53but how are we going to do
  • 14:54this in an equitable way.
  • 14:55And so just to make sure
  • 14:56we're on the same page,
  • 14:57I like to use this definition that
  • 14:59was in a blog post in the journal
  • 15:02Health Affairs that HealthEquity
  • 15:03refers to providing a fair and
  • 15:05just opportunity to be healthy by
  • 15:07reducing and ultimately eliminating
  • 15:09disparities in health and its
  • 15:11determinants that adversely affect
  • 15:13excluded or marginalized groups.
  • 15:15So or seeing.
  • 15:16All of the work here today is that we
  • 15:19need to be integrating HealthEquity
  • 15:22with implementation science.
  • 15:23So let's go back to this first
  • 15:26strategy of using hybrid trials.
  • 15:28When I've talked to Jeff Kern
  • 15:30and Brian Mittman,
  • 15:30authors of the Seminole Paper
  • 15:33on hybrid designs from 2012,
  • 15:35they wish they would have emphasized
  • 15:36more in that paper that every
  • 15:38randomized control trial should
  • 15:39be a hybrid type one trial.
  • 15:41As I mentioned, you can do a really rigorous,
  • 15:45unbiased trial of effectiveness,
  • 15:47and some people are now doing
  • 15:49it in efficacy work while also
  • 15:52collecting implementation context.
  • 15:53Along the way,
  • 15:54and this is the information that's
  • 15:56going to help you understand
  • 15:57what it is that you still need
  • 15:59to do to increase this uptake of
  • 16:01evidence into practice.
  • 16:02If we do hybrid trials that have
  • 16:04a focus on effectiveness we need,
  • 16:07we can then also hopefully not need to do
  • 16:12as much adaptation of our intervention
  • 16:15or our strategies in the future.
  • 16:17So we always talk about interventions have
  • 16:19core components and those are essential.
  • 16:21We can't change those.
  • 16:23There are essential things about,
  • 16:25you know,
  • 16:26cognitive behavioral therapy
  • 16:27that have to happen.
  • 16:29But we can talk about cultural adaptations,
  • 16:31we can talk about setting adaptations.
  • 16:34Targeted audience adaptations,
  • 16:35the people who deliver them.
  • 16:37Adaptations that will not change the core
  • 16:40components of cognitive behavioral therapy,
  • 16:43but will increase the uptake
  • 16:44of its use in practice.
  • 16:46And if we start there,
  • 16:48as opposed to a really highly
  • 16:50controlled efficacy trial,
  • 16:51we might actually be able to build
  • 16:53those things in and not need to do so
  • 16:55much adaptation work in the future.
  • 16:57We also need to be as Chalmers
  • 16:59and colleague mentioned earlier
  • 17:00that really need to think about
  • 17:02what are the research questions
  • 17:03that are relevant to the end users
  • 17:05that could be the providers who
  • 17:07are going to be delivering them,
  • 17:08the patients,
  • 17:08families who are going to be receiving them,
  • 17:11participating in them.
  • 17:11So think about that early on and we
  • 17:14can do that in a hybrid trial and also
  • 17:16then focus on that pragmatic issues,
  • 17:18you know,
  • 17:18making sure that the outcomes that
  • 17:20we're measuring are relevant to
  • 17:22participants that that we're not
  • 17:23as rigid in who can participate
  • 17:25in our trials and that helps
  • 17:27with. Increasing HealthEquity and then also
  • 17:30expanding our recruitment efforts as well.
  • 17:34So my colleagues Megan landfall,
  • 17:36Jeff Kern and Renat Badas created
  • 17:38this what I love this really cool
  • 17:41subway map of implementation research.
  • 17:43And so you can really identify
  • 17:45yourself along this line.
  • 17:46So where are you in terms of
  • 17:48your practice of interest?
  • 17:50You know, what is it that you want to
  • 17:52see implemented in real world settings?
  • 17:54And then you can follow along,
  • 17:55where are you?
  • 17:56And so if you feel that you really
  • 17:59still need more efficacy research, done.
  • 18:02And you can still design for implementation
  • 18:05and that's why a hybrid designs are
  • 18:08now moving into the efficacy space.
  • 18:10You can still do the,
  • 18:12you can still do efficacy research,
  • 18:14really rigorous control things
  • 18:16and obviously of course in drug
  • 18:18medication trials this is essential.
  • 18:21But you can still be collecting information
  • 18:23on what are the perceived benefits of this,
  • 18:26what are the challenges to doing
  • 18:27this so that you are prepared for
  • 18:29moving this forward and in fact
  • 18:31if you are aware of the VA's.
  • 18:33Cooperative studies program where
  • 18:35trials are funded at like $35 million.
  • 18:38They now have a policy that everyone
  • 18:42of those very large 5 to 7 year
  • 18:45trials must be a hybrid type 1.
  • 18:48So you even if you're doing efficacy
  • 18:50research think about a hybrid type
  • 18:52one or maybe you feel that you
  • 18:54still need to do effectiveness.
  • 18:55You you have efficacy you can move
  • 18:59into effectiveness but you know this
  • 19:01is where the comment from current and
  • 19:03mitman come in that even an effectiveness
  • 19:05research trial should be a hybrid one.
  • 19:07Think you should be thinking about how
  • 19:09you can get yourself onto that green line.
  • 19:12I don't know if you you know in
  • 19:13Boston we just call our subway lines
  • 19:15by colors red line, yellow line,
  • 19:17green line, the red line right now.
  • 19:19It's not so great in the subway
  • 19:21world in Boston.
  • 19:22The Orange Line,
  • 19:23which we don't have here is horrific.
  • 19:25The green line is OK.
  • 19:27Hopefully the green line here
  • 19:28for implementation research is
  • 19:29a little bit better.
  • 19:31But I feel like,
  • 19:32you know,
  • 19:33you can do a hybrid trial at any
  • 19:35point and you can also be doing
  • 19:37these mixed method studies,
  • 19:38designing and testing your
  • 19:41implementation strategies.
  • 19:42So in this trial which I will tell
  • 19:44you started out as more of a clinical
  • 19:46trial and I am not a clinical trialist.
  • 19:48I partnered with my colleague Jill
  • 19:50Bornman at VA San Diego to do a
  • 19:53trial testing mantram repetition or
  • 19:54mantra meditation as a treatment for
  • 19:57post traumatic stress disorder among
  • 19:59veterans who had been in combat.
  • 20:02And our our funder which was VA
  • 20:04clinical services research and
  • 20:06development really wanted more
  • 20:07efficacy trials but we did some
  • 20:10pre work talked to a lot of.
  • 20:12Stakeholders,
  • 20:12because of our implementation
  • 20:14science background and found that
  • 20:16what we intended to do in this
  • 20:18trial was not going to work.
  • 20:20Maybe it could have worked
  • 20:21in the trial itself,
  • 20:22but it wasn't going to work long term.
  • 20:23So for example, one of the
  • 20:25things that we wanted to do was
  • 20:26do this as a group treatment.
  • 20:27We wanted to do group based monitoring,
  • 20:29repetition. Jill had done lots of
  • 20:32work already with mantram repetition.
  • 20:34In this case, she had been looking to
  • 20:37see how it could increase adherence
  • 20:39to HIV treatment and she wanted
  • 20:40to now move it into this PTSD.
  • 20:42Space and we talked to veterans of
  • 20:44all genders and found that they had
  • 20:47absolutely no intention of doing
  • 20:48this in a group based setting,
  • 20:50but they were very happy to participate
  • 20:53this in individual treatment.
  • 20:54So we had to request a modification
  • 20:56and move into individual treatment
  • 20:57and that was our first step in
  • 20:59that pragmatic space of thinking
  • 21:01about that flexible delivery.
  • 21:03We cannot do how this had initially
  • 21:05been planned because we knew
  • 21:06even if it worked in this trial,
  • 21:08it wasn't going to work in the real world.
  • 21:10The other thing we did is we
  • 21:11really thought about who would
  • 21:12be delivering these services and
  • 21:14that's another pragmatic issue.
  • 21:15We didn't want to hire PhD level
  • 21:17people who were going to disappear
  • 21:19after the study and we're only
  • 21:21going to be interventionist.
  • 21:23And so we talked to the clinicians.
  • 21:26Masters degree level clinicians at each
  • 21:28of our sites to see who would want
  • 21:30to become involved in this project
  • 21:32and so we really didn't involve the people,
  • 21:35a lot of social workers for example,
  • 21:37who would be involved in delivering
  • 21:39mantra repetition in the future.
  • 21:41So that was a great,
  • 21:42great first step towards becoming
  • 21:44more of a pragmatic design.
  • 21:46Mantram repetition Mantra Meditation
  • 21:48was developed by Eknath Ishwaran,
  • 21:51who developed the Blue Mountain
  • 21:53Retreat Center Meditation Retreat
  • 21:55Center in San Diego.
  • 21:57And you know,
  • 21:58Mantram is just it's it's so simple,
  • 22:02which is actually essential
  • 22:04for implementation.
  • 22:05It's not complex at all,
  • 22:06and these are a couple of the books
  • 22:08available at that website there.
  • 22:10But really, mantram is a way of slowing down,
  • 22:15having focused attention.
  • 22:16Trying to make sure that you can
  • 22:19block out a lot of the challenges,
  • 22:21especially the kinds of things that
  • 22:23happen in post traumatic stress disorder,
  • 22:25nightmares incurring.
  • 22:26So you the person starts,
  • 22:28the first thing that you have to
  • 22:30do is actually pick a montrem
  • 22:31if you're in this group.
  • 22:32And so the mantram has to be
  • 22:34a spiritual word or phrase.
  • 22:36It doesn't.
  • 22:36You don't have to be a religious person,
  • 22:38but you need to have a sense of
  • 22:41higher order and can come from
  • 22:43any religion and if any of these
  • 22:46religious or spiritual words.
  • 22:48Don't seem to fit for someone.
  • 22:49They can pick something else.
  • 22:52And so we would say if none of these work,
  • 22:54you can just use the word one.
  • 22:56You could not use anything vulgar,
  • 22:58you couldn't use a swear word,
  • 22:59etcetera, had to have a higher order.
  • 23:01And we often say to people that
  • 23:03your mantra will pick you.
  • 23:05So for example, I went through the
  • 23:07training myself because I thought, well,
  • 23:08if I'm going to be trying to do this trial,
  • 23:09I need to practice mantra meditation
  • 23:11and see what this is like.
  • 23:13And I really wanted the word.
  • 23:15I really wanted the phrase Om Namah shivaya.
  • 23:18It sounds so beautiful, you know,
  • 23:20and a lot of these words come from
  • 23:23Sanskrit or are, you know, maybe Hindi.
  • 23:26Some of these words are from Buddhism,
  • 23:29others are from Judaism,
  • 23:32Christianity, etcetera.
  • 23:33I really wanted Onama shivaya
  • 23:35invocation to beauty and fearlessness.
  • 23:38But as I went through the training and
  • 23:40you need to learn how to invoke the mantra
  • 23:42when you need it, like on the spot,
  • 23:44I couldn't remember my mantra and
  • 23:46so then I understood why the mantra.
  • 23:48Makes you the one word that I
  • 23:50could remember always was Rama,
  • 23:51Eternal joy within.
  • 23:52So that became my mantra.
  • 23:54So I would silently say it to myself.
  • 23:57I would write it down.
  • 23:58Those are the kinds of things that we
  • 24:01ask people to do when they need it.
  • 24:03First you learn how to use the
  • 24:04mantra when you don't need it,
  • 24:05and then you move to using
  • 24:07it when you need it.
  • 24:09And we compared this to a very active
  • 24:11treatment arm of present centered therapy,
  • 24:14which through Polish,
  • 24:16schnurr and others has really
  • 24:19established very strong.
  • 24:21Effectiveness and efficacy work.
  • 24:23It's really helping people to
  • 24:25alter their present maladaptive
  • 24:27reactions and patterns and providing
  • 24:30some sorry cycle education.
  • 24:32And importantly,
  • 24:33there's no meditation at all
  • 24:34and no mantra meditation.
  • 24:36And so it was a really good
  • 24:38comparison arm and again,
  • 24:38we had masters level people
  • 24:41who were using this.
  • 24:42And importantly,
  • 24:43in both of our mental health settings,
  • 24:46neither one of these treatments
  • 24:48was available as routine and so
  • 24:50it was considered something new.
  • 24:51Any veteran participating?
  • 24:52And so we use the caps,
  • 24:55which is I will admit is not
  • 24:56exactly the outcome that matters
  • 24:58to the people who are using.
  • 25:00It is very difficult to both
  • 25:02administer and participate in.
  • 25:04But you know,
  • 25:05we had 89 people in our monitoring
  • 25:07group and 84 in our present centered
  • 25:10group and the Montreal Group improved
  • 25:13tremendously on that measure over time.
  • 25:15And so the present centered
  • 25:17group also improved,
  • 25:18but not as much as the mantra in
  • 25:20terms of the Caps scoring and
  • 25:22we also wanted to know.
  • 25:23What was driving PTSD and so we
  • 25:25thought that we could maybe find out
  • 25:28if insomnia had anything to do with this.
  • 25:30And so we asked about the using
  • 25:33the Insomnia Severity Index and
  • 25:35found that the present centered
  • 25:37therapy group really didn't change
  • 25:38in terms of insomnia over time.
  • 25:40But the sorry the the mantra group
  • 25:43did that their insomnia improved a
  • 25:46little bit and kept going down but
  • 25:48didn't get to the point where it
  • 25:51it wasn't clinically meaningful.
  • 25:52Both things both groups still
  • 25:53had clinically meaningful.
  • 25:55Some symptoms.
  • 25:57And so this is where we were like we need
  • 25:59to know about how,
  • 26:00how is this actually going to work?
  • 26:01We saw that it works in this group of
  • 26:04veterans with post Traumatic stress
  • 26:07disorder resulting from combat.
  • 26:09But what was it going to take
  • 26:11to make this work in real life?
  • 26:13And so this is where a
  • 26:14process evaluation comes in.
  • 26:15After the recruitment was done,
  • 26:18after providers were no longer
  • 26:20referring patients to us and providers
  • 26:22were such an essential part of this.
  • 26:25So they really needed to have.
  • 26:27Buy in, they needed to believe
  • 26:28that we were doing something unique
  • 26:30and helpful for the veterans
  • 26:32that they were serving.
  • 26:33We wanted to find out from them what
  • 26:35were are some potential barriers
  • 26:37and facilitators to implementation
  • 26:38that we can think about now so
  • 26:40that we can address in the future.
  • 26:42And so this gets into strategy #2 already,
  • 26:45which is the that we were guided by
  • 26:47theory with this and we chose the
  • 26:49theory of diffusion of innovation
  • 26:51which actually was not developed
  • 26:53in healthcare at all,
  • 26:54really developed in the agricultural space.
  • 26:57And really says that there are
  • 26:59key features of any innovation,
  • 27:02any adoption of innovation.
  • 27:03And that is that a user will see it
  • 27:06as a perceived relative advantage
  • 27:07compared to anything else that they're doing,
  • 27:10that it's compatible with their
  • 27:12perceived needs, values, norms,
  • 27:14low complexity,
  • 27:15sure.
  • 27:16Yet that's essential and have the
  • 27:18best intervention in the world.
  • 27:19But if it's seen as too complex,
  • 27:21it won't be adopted.
  • 27:22And so these are the kinds of things
  • 27:24that we needed to assess in our
  • 27:26process evaluation with our providers.
  • 27:28Did they see this as a relative advantage
  • 27:30for themselves and their veterans?
  • 27:31Did they see it compatible
  • 27:32with their perceived needs,
  • 27:33values and norms and their veterans?
  • 27:36And was it low in complexity to
  • 27:38them and also to their veterans?
  • 27:41And what the theory of diffusion
  • 27:43of innovation says is when we
  • 27:44start to have conversations,
  • 27:46peer-to-peer conversations with others
  • 27:47that we work with who are in our networks,
  • 27:50in our communities,
  • 27:51and we hear what they think
  • 27:54about that innovation,
  • 27:55then we start to consider change
  • 27:57and we start to consider adoption.
  • 27:59And we do this because we have
  • 28:01a sense of trust.
  • 28:02We believe in the person
  • 28:03that we're talking to.
  • 28:04And although we may not have seen
  • 28:07this benefit yet of this innovation,
  • 28:09we start to trust them.
  • 28:11Because they are already somebody
  • 28:13who we consider credible,
  • 28:15and if they're telling us that it works,
  • 28:17we're going to try it out too.
  • 28:20And so we did a survey with 69 of
  • 28:22the providers who participated in
  • 28:24this trial in terms of referring
  • 28:26patients to us and then we did a 12
  • 28:30interviews with a subset of those just
  • 28:32to get a little bit more deeper dive.
  • 28:34And from the survey and the interviews
  • 28:36we really had three main themes
  • 28:38that came out that were can really
  • 28:40inform implementation of this
  • 28:42mantra meditation in the future.
  • 28:44We the first two are things
  • 28:45that have been talked
  • 28:46about in the literature already that you know
  • 28:48believing in one's own clinical judgment.
  • 28:49Often Trump's the actual evidence based
  • 28:52treatment because we just don't see
  • 28:54that as being relevant for our patient.
  • 28:57And then there are some other factors.
  • 28:59But what was new in our work
  • 29:01was that people, clinicians,
  • 29:03providers were doing just extraordinary
  • 29:06things to deliberately manufacture time,
  • 29:09to have conversations with
  • 29:10trusted others in their clinic,
  • 29:12to learn more about Mantra meditation,
  • 29:15to learn more about other evidence based
  • 29:18treatments for PTSD and so for example.
  • 29:21Things that they told us was that,
  • 29:22you know, they wanted to have
  • 29:24lunch to talk about these things,
  • 29:26and they knew that having lunch
  • 29:28would mean that they'll have to stay
  • 29:30late to write their clinical notes.
  • 29:31But doing this once a month or so
  • 29:33is worth it because it was at this
  • 29:36lunchtime conversation that they
  • 29:37learned important aspects of treatment.
  • 29:39That they really went to great effort
  • 29:41to talk to colleagues outside of work
  • 29:43and even walking to a colleague's car
  • 29:45after work in order to have 10 minutes
  • 29:48outside of the car was how they snuck
  • 29:50time they were sneaking time to have
  • 29:52these conversations with just really
  • 29:54resonated as just like a way of trying
  • 29:57to learn whatever they could and really
  • 30:00emphasize to us how conversations
  • 30:02about evidence based practices,
  • 30:04mantra,
  • 30:04meditation,
  • 30:05anything are really not interwoven
  • 30:07into the system yet and.
  • 30:10In a way that is helpful for change.
  • 30:12So here we're not talking about
  • 30:14anything really related to the
  • 30:16meditation trial in terms of the
  • 30:18meditation as an intervention.
  • 30:20We're talking about all of the organizational
  • 30:22and cultural things that are happening
  • 30:24in settings that we need to address.
  • 30:26And we took this information and said
  • 30:28this is the implementation strategy
  • 30:30that we need to use in future work.
  • 30:33We need to think about how do
  • 30:35you promote network weaving and
  • 30:36that is identifying and building
  • 30:38out existing high quality working
  • 30:40relationships within an organization.
  • 30:42To promote information sharing,
  • 30:44collaborative problem solving,
  • 30:45shared goals related to an implementation.
  • 30:48This is one of those 73 implementation
  • 30:50strategies that's listed in
  • 30:52Byron Powell's 2015 paper.
  • 30:53But this really showed us that
  • 30:55what we were learning from our
  • 30:57providers was what we needed to do.
  • 30:58And so we have since developed a social
  • 31:01network survey of three questions asking
  • 31:03people who do they talk to at work?
  • 31:05Who do they seek advice from,
  • 31:07who do they go to when there's a difficult
  • 31:10clinical problem that they have,
  • 31:11and answers to these questions.
  • 31:13Help us identify who those champions are
  • 31:15at each other's sites and who we can
  • 31:18involve in our implementation efforts
  • 31:20and how we can promote network weaving.
  • 31:22How can we get that champion,
  • 31:24that trusted person,
  • 31:25to start talking to other people
  • 31:27about the implementation effort.
  • 31:29And that's really essential.
  • 31:30And so without having done a hybrid type
  • 31:33one and adding this process evaluation,
  • 31:35we would never have known this.
  • 31:38And so this moves us into Strategy 2,
  • 31:40which is let theory be your guide.
  • 31:41And I know you know that.
  • 31:43You've all seen this quote from Kurt Lewin.
  • 31:44Nothing is more practical than a good theory.
  • 31:47And one of the things that this
  • 31:49addresses in the Chalmers that all
  • 31:51research waste issue is that theory
  • 31:53can help us develop appropriate
  • 31:55research design methods and analysis.
  • 31:57And hopefully that will help us speed
  • 32:00that public health impact translation.
  • 32:02I always tell people that
  • 32:03theory is your friend.
  • 32:04It tells you what you need to measure.
  • 32:06It tells you how frequently.
  • 32:09Perhaps you need to do this.
  • 32:10What are the kinds of concerns that that
  • 32:12might occur that you haven't thought about?
  • 32:14And also, we won't waste research
  • 32:16dollars if we're collecting data
  • 32:18that we're not intending to use.
  • 32:20Theory helps us figure that out,
  • 32:22and this is a wonderful website
  • 32:24that is a collaboration between
  • 32:25the University of Colorado and
  • 32:27Washington University in Saint Louis.
  • 32:29You can go to the website here.
  • 32:30It's free to use.
  • 32:31There are lots and lots of
  • 32:33different theories, models,
  • 32:34and frameworks to look at that are used
  • 32:37in the implementation science space.
  • 32:39In a paper in 2018 by Sharon
  • 32:42Strauss and colleagues in Toronto,
  • 32:44they identified at least 159 theories,
  • 32:47models and frameworks.
  • 32:48So we don't need any more
  • 32:50development of these theories,
  • 32:51models and frameworks.
  • 32:52We just need to figure out
  • 32:54which ones work for us.
  • 32:56So in my work that I'm doing
  • 32:58in the VA with my colleagues,
  • 33:00Umm Keith McGuinness,
  • 33:01Amanda Midboe, David Snelson,
  • 33:03we have something called the bridge.
  • 33:05Prairie Bridge is a short name
  • 33:07for bridging the care continuum
  • 33:09for vulnerable veterans in VA
  • 33:11and community care settings.
  • 33:13And we're really focusing on how to
  • 33:15increase the uptake of three different
  • 33:18evidence based practices related
  • 33:19to mental health and substance use.
  • 33:22We're in each of these projects.
  • 33:24Each one is a hybrid Type 3 design.
  • 33:25Being implemented in at least
  • 33:27six sites around the country.
  • 33:29Some of these are VA sites,
  • 33:30some of these are community based sites.
  • 33:32So for example,
  • 33:33the top one veterans with opioid
  • 33:35use disorder,
  • 33:36this is the homeless overdose
  • 33:39prevention expansion program
  • 33:41that's being led by Amanda Midvale.
  • 33:43And the one on the bottom right is on
  • 33:46veterans released from incarceration.
  • 33:49This is the pie program.
  • 33:51This is called the post Incarceration
  • 33:53engagement program and the.
  • 33:55Now on the bottom left is the
  • 33:59mission CJ program,
  • 34:00and this is the maintaining independence
  • 34:03and sobriety through systems integration,
  • 34:05outreach and networking.
  • 34:07Criminal justice,
  • 34:08which is why I had to look at my notes
  • 34:09because I can never remember that.
  • 34:11But in each of these there are there's
  • 34:13lots of evidence for this treatment.
  • 34:16We are trying to, in some cases,
  • 34:19use peers.
  • 34:19So having a flexible delivery
  • 34:21model and also thinking about who
  • 34:23can deliver these interventions,
  • 34:24we're using peer specialists.
  • 34:26And we're trying to do this in what
  • 34:28we're doing this in a hybrid Type 3,
  • 34:31which means that our focus is on
  • 34:33the implementation strategies.
  • 34:34So I'll say more about that.
  • 34:36And so here are the projects and
  • 34:38I lead the implementation core,
  • 34:40which is responsible for overseeing
  • 34:43the tracking of the implementation
  • 34:45strategies that we're using,
  • 34:47focusing on how we can increase
  • 34:49the spread and sustainability and
  • 34:51making sure that each of the projects
  • 34:53is collecting the same outcomes,
  • 34:54implementation outcomes and
  • 34:56effectiveness outcomes.
  • 34:57So that we can make some comparisons
  • 34:59across these 18 sites that are involved.
  • 35:02Even though there are three different
  • 35:04evidence based practices happening,
  • 35:06a hybrid Type 3 focus is really on.
  • 35:09That's the last hybrid step before
  • 35:12truly trying to sustain something
  • 35:15in in routine care.
  • 35:17And so as a result of that,
  • 35:18we decided to use the dynamic
  • 35:21sustainability framework as our way
  • 35:23of focusing on not just implementation
  • 35:26of sustainability and the DSF,
  • 35:28which was developed by David Chambers,
  • 35:30Russ Glasgow Heart stage Dangy is
  • 35:33that we need to constantly assess
  • 35:35not just one time,
  • 35:37but over time how the intervention
  • 35:40fits with the practice setting and
  • 35:42fits within the ecological system.
  • 35:44So oftentimes we only assess
  • 35:46these things once.
  • 35:47But we really need to do this overtime.
  • 35:49And so we have developed a system
  • 35:51of looking at pre implementation,
  • 35:52implementation and sustainability
  • 35:54across these three hybrid type threes.
  • 35:56So we're always learning about what's
  • 35:58happening with the intervention,
  • 36:00what needed to be adapted,
  • 36:02how are things working in that
  • 36:03particular practice setting,
  • 36:04because sometimes we are in jail
  • 36:06settings that are outside the VA,
  • 36:08sometimes we are in outpatient settings.
  • 36:10So we need to figure out you know what
  • 36:12the organizational climate is like,
  • 36:14what's the staffing,
  • 36:14what kind of training and supervision
  • 36:16is needing and then.
  • 36:17Certainly the ecological system which
  • 36:19is our real world factors like what's
  • 36:22happening in the world of policy
  • 36:24and regulation and market forces.
  • 36:25So a perfect example is that we
  • 36:28intended to have these sites,
  • 36:30the 12 of the sites that are using peers,
  • 36:33higher peers at certain times.
  • 36:35So that we could use a cluster
  • 36:38randomized stepped wedge design
  • 36:40to roll out our evidence based
  • 36:42practices to sites at a time.
  • 36:44And then COVID hit this actually this
  • 36:46grant got funded on October 2020,
  • 36:49so we were in the midst of COVID and then
  • 36:52the American Rescue Plan Act got funded.
  • 36:55The ARPA in VA got lots of
  • 36:58money to hire peers.
  • 36:59And so even though we had staggered our
  • 37:02hiring at peers at these sites to meet
  • 37:05with our cluster stepped wedge design,
  • 37:08we could no longer have a
  • 37:10stepped wedge design because our
  • 37:12sites got peers immediately so.
  • 37:14In terms of flexible adaptation,
  • 37:17we had to switch from a stepped wedge
  • 37:20design to more of an adaptive design,
  • 37:23and that was a really hard switch
  • 37:25in the middle of our planning,
  • 37:27but was essential because of
  • 37:29the ecological system changes.
  • 37:32And one of the things that I'm overseeing
  • 37:34is that we are randomizing sites in
  • 37:36now are now adaptive designs to either
  • 37:39receive high intensity strategies
  • 37:41which we're calling implementation
  • 37:43facilitation or low intensity
  • 37:45strategies of education,
  • 37:47outreach and academic detailing.
  • 37:48And both of these have very clear
  • 37:51definitions of what they are and we
  • 37:53are tracking and in a hybrid type 3,
  • 37:56the research groups do not do
  • 37:58the implementation strategy work,
  • 38:00we train people on the sites.
  • 38:02Appears that we've hired or in the
  • 38:04case of the Hope project we train a
  • 38:06lot of the social workers who are
  • 38:08involved to actually do the training
  • 38:10of the intervention at that site.
  • 38:12And so they we are using our
  • 38:14implementation strategies with those
  • 38:16those people and then they in turn
  • 38:19are delivering the intervention.
  • 38:20And so I you know often talk about
  • 38:23implementation science being
  • 38:24just gigantic tracking effort.
  • 38:26We track a lot of things.
  • 38:28We have calls often with the
  • 38:29sites to learn what they're doing
  • 38:30and talk to the point of.
  • 38:32Contact to learn more about what's happening.
  • 38:35We've created dashboard to look at the
  • 38:37different outcomes that we are assessing.
  • 38:39This is just a fake version just
  • 38:41for presentation to show that we're
  • 38:43trying to learn about acceptability,
  • 38:45appropriateness, feasibility and
  • 38:47trying to see if organizational change,
  • 38:50readiness for implementing change
  • 38:53changes increases, gets worse etcetera.
  • 38:56Over the time of the of the project,
  • 38:58people will be hired,
  • 39:00people will leave at cultural changes
  • 39:02will happen.
  • 39:03So we're just trying to track all of that
  • 39:05and see how that impacts sustainability.
  • 39:07We are actually presenting this
  • 39:09work as part of a symposium at
  • 39:12the DI Conference in in December
  • 39:14if people attend that conference.
  • 39:17And the other thing that we're
  • 39:18doing is we're also keeping track
  • 39:20of the qualitative work that we're
  • 39:22collecting according to the Dynamic
  • 39:24sustainability framework pieces
  • 39:25and to see what we can learn from
  • 39:27that in order to adapt any of
  • 39:29our strategies if needed.
  • 39:30And we're also presenting
  • 39:32that work at the conference.
  • 39:33So the third strategy is that we need to
  • 39:35get to know your stakeholders and this is.
  • 39:37To go back to the Chalmers piece,
  • 39:39we need to be have research that's
  • 39:40relevant to the users of the
  • 39:42research and we need to provide fully
  • 39:44accessible research information.
  • 39:45And we can do this if we build these
  • 39:47partnerships and these relationships
  • 39:49with our stakeholders from the beginning.
  • 39:51And so a project that I've done with
  • 39:53colleagues and Pittsburgh funded by pecori,
  • 39:55this is the heel study.
  • 39:57Heel was developed long before the
  • 39:59night of heel and in this case
  • 40:01heel stands for healing encounters
  • 40:03and attitudes list.
  • 40:04It's a set of 6 self report questionnaires
  • 40:07built on the promise methodology.
  • 40:10Really generalizable to any treatment,
  • 40:11but we're trying to use them
  • 40:13to see what we can,
  • 40:14how these measures might be used to reduce
  • 40:17opioid use in community based pain clinics.
  • 40:21And so these are our measures of treatment,
  • 40:23expectancy,
  • 40:23patient provider connection,
  • 40:25healthcare environment,
  • 40:27positive outlook,
  • 40:28spirituality added towards
  • 40:29towards complementing restorative
  • 40:31medicine through spirit.
  • 40:33Through our formative evaluation work.
  • 40:35We actually decided not to focus
  • 40:37on spirituality and attitudes
  • 40:38and only use healthcare
  • 40:40environment a little bit.
  • 40:41So most of the project focuses on treatment,
  • 40:43expectancy, patient provider,
  • 40:45connection and positive outlook and we
  • 40:48partnered every Pecori project has to
  • 40:50have stakeholders involved anyway and so.
  • 40:51We partnered with the UPMC Pain
  • 40:54Medicine Chair, Vice Chair,
  • 40:55and even though UPMC is
  • 40:57central in Pittsburgh,
  • 40:58a lot of their satellite clinics are
  • 41:00suburban and some are even considered
  • 41:02rural because they read they're
  • 41:04like 2 hours away from Pittsburgh.
  • 41:06And so it was a really great place to
  • 41:08try to do a true implementation project.
  • 41:11Carol Greco,
  • 41:12who led the project with Ajay Wassan,
  • 41:14had already done so much work to show
  • 41:16that there was a strong relationship
  • 41:18between responses to treatment expectancy,
  • 41:20positive outlook.
  • 41:21Patient provider relationship and
  • 41:23promise measures of pain severity,
  • 41:25promise measures of global
  • 41:27functioning etcetera.
  • 41:28We just wanted now to see can we put
  • 41:30these measures into what was already
  • 41:32happening in the clinic and the clinic
  • 41:35was already using the choir platform,
  • 41:37the collaborative Health Outcomes
  • 41:39Information Registry and open source
  • 41:41web-based patient reported outcome
  • 41:43application where patients are sent
  • 41:45an e-mail link and or they can
  • 41:47complete the survey questions on
  • 41:48a clinic pad and the survey is of.
  • 41:52The promised measures had started
  • 41:53in 2016 and we wanted to roll into
  • 41:56this the treatment expectancy,
  • 41:58patient provider out,
  • 41:59patient provider relationship
  • 42:01and positive outlook questions.
  • 42:03So this is the kind of report on
  • 42:05the promise measures that clinicians
  • 42:06in the pain clinics would get
  • 42:08before they saw their patients.
  • 42:10And so we would be adding in these
  • 42:12treatment expectancy questions for example,
  • 42:14so that they could look at them.
  • 42:15And the whole goal was to try to
  • 42:18increase greater conversation about
  • 42:20pain treatment between the provider
  • 42:22and the patient and reduce opioids
  • 42:25hopefully and then refer to other
  • 42:27non pharmacological treatments.
  • 42:28And so we had a lot of,
  • 42:31we did formative evaluation work,
  • 42:33we did process evaluation and
  • 42:35summative evaluation.
  • 42:35But really the intervention here
  • 42:37was putting these heel measures
  • 42:39into the choir platform,
  • 42:40so involved the IT group and then
  • 42:43trying to use our strategies to get.
  • 42:46Clinic staff to talk to this
  • 42:47about with their with their people
  • 42:49who check in for the clinic,
  • 42:51trying to talk to the providers about it,
  • 42:53reminding them that these aren't.
  • 42:56Measuring.
  • 42:57A.
  • 43:01There's evaluation work,
  • 43:02and the other work is forthcoming.
  • 43:05And here are some examples
  • 43:07of treatment expectancy.
  • 43:09So Umm, you know,
  • 43:10not surprising to any of you,
  • 43:13but I'm confident in this treatment,
  • 43:15this treatment will be successful.
  • 43:16I feel good about this treatment, etcetera.
  • 43:18And so our formative work was really to
  • 43:20talk to patients and providers and staff
  • 43:22to find out what they thought about it.
  • 43:24And again, we drew on the theory
  • 43:26of diffusion of innovation.
  • 43:27So we wanted to know what
  • 43:29did they think about it.
  • 43:30And we were able to figure out what was the
  • 43:32relative advantage of this considered higher,
  • 43:34low and so some patients.
  • 43:36Said that it was high that, you know,
  • 43:38when they go to the pain center,
  • 43:39they don't expect to leave pain free.
  • 43:41They want their pain just to
  • 43:43be manageable or tolerable.
  • 43:45They think that their doctor feels that
  • 43:47the opioid problem is people not wanting
  • 43:48to have pain and but really what they
  • 43:50want is just to be able to manage it.
  • 43:52And so they felt it would be great
  • 43:54to answer these treatment expectancy
  • 43:56questions and then to have a conversation
  • 43:58with their provider about it.
  • 44:00Some providers thought it would be
  • 44:02a great idea because they are very
  • 44:04interested in treatment expectancy.
  • 44:05They know how it affects.
  • 44:06Pain perception.
  • 44:07And then some patients
  • 44:09and providers thought oh,
  • 44:10these,
  • 44:10you know,
  • 44:11these questions are really repetitive
  • 44:13and people aren't going to want to
  • 44:15listen to this or people aren't going
  • 44:17to want to complete these items.
  • 44:19And so they were really doubtful about it.
  • 44:20And then this gave us some information
  • 44:24to develop implementation strategies.
  • 44:26And so for patients,
  • 44:28we did these FAQ sheets where we
  • 44:31look specifically at, you know,
  • 44:34these questions seem repetitive.
  • 44:35Do I really need to answer these,
  • 44:36you know, will my doctor talk to me about?
  • 44:38These will these affect my treatment.
  • 44:39Those are the kinds of things that
  • 44:41we were hearing from patients and
  • 44:43our interviews and so we created some
  • 44:45educational strategies to address that.
  • 44:47For providers,
  • 44:47we went a little bit more actively
  • 44:50and we created these six videos
  • 44:52with our stakeholder champion,
  • 44:55the clinic lead about the different
  • 44:57types of measures that we were
  • 45:00using and really sharing with
  • 45:02providers what was important.
  • 45:04So they were short,
  • 45:06you know two-minute videos
  • 45:07that we sent to clinics.
  • 45:09The clinics would then do a little red
  • 45:11CAP survey to to say that they'd watched
  • 45:12it and then you know the Clinton,
  • 45:14we had a little competition going,
  • 45:16clinics who watched more of the survey,
  • 45:20more of the videos,
  • 45:22got coffee and Donuts for that week.
  • 45:24So just trying to get the word out in
  • 45:27an educational strategy and sort of
  • 45:29engaging way about why it's important
  • 45:31to do this because this project was
  • 45:34a true implementation project.
  • 45:36It was not a hybrid type three.
  • 45:37We did not have any research.
  • 45:39Staff in the clinics,
  • 45:40we were just trying to remotely
  • 45:42convince people at these clinics
  • 45:43that this is what they needed to do,
  • 45:46and so a real true test of behavior change.
  • 45:50And so we're still working on the results.
  • 45:52The project has ended in April,
  • 45:55but you know over we have these
  • 45:56different nine month periods that
  • 45:58we looked at and there were a lot of
  • 46:00unique patients at these clinics,
  • 46:01a lot of patient appointments and
  • 46:04we looked at initially did patients
  • 46:06complete the surveys and did staff
  • 46:08complete looking at those reports
  • 46:10because we really didn't have any
  • 46:12other way of seeing how engaged
  • 46:14they were with these results.
  • 46:16So pre implementation of
  • 46:18these measures which was 2018.
  • 46:21These were sort of our baseline when it
  • 46:23was just the patient reported outcomes,
  • 46:25just the promise measures in the
  • 46:26system surveys were being completed,
  • 46:28about 72% of the patients,
  • 46:30about 79% of the staff were looking at these.
  • 46:32These are pretty high numbers and
  • 46:34we didn't know if we'd be able
  • 46:36to improve upon that post heal,
  • 46:38but still pre COVID around 2019,
  • 46:41so post heal implementation,
  • 46:43so now the heel measures of treatment
  • 46:46expectancy etcetera are in the system
  • 46:48are more people completing the surveys.
  • 46:51Not really.
  • 46:52Our more staff reviewing their reports.
  • 46:54No, it's totally the same.
  • 46:56And so we had to like up our
  • 46:59implementation strategies.
  • 46:59We did further educational efforts,
  • 47:02we did a retreat.
  • 47:03We did started doing journal clubs,
  • 47:04we did lunch and learns,
  • 47:06then COVID hits and everything
  • 47:09went remote and interestingly.
  • 47:11As a result of telemedicine,
  • 47:13when people could not see their patients
  • 47:15and patients could not see their
  • 47:17doctors in real life everything was virtual.
  • 47:19We had a higher survey completion rates.
  • 47:22And we had a higher rate of clinicians
  • 47:24and staff looking at those reports and
  • 47:27so really indicated that there was
  • 47:30a real need for understanding more
  • 47:32about how people were feeling about
  • 47:34their treatments in this telemedicine space.
  • 47:37And when we looked at changes over time
  • 47:40in terms of what was happening with,
  • 47:43you know, and we and it's not
  • 47:45a controlled trial at all,
  • 47:460 control on this.
  • 47:47We're making a lot of assumptions and of
  • 47:49course there are a lot of limitations here.
  • 47:51But we can see that from 2018 until now,
  • 47:55there's been a big increase in
  • 47:57referrals to integrative medicine,
  • 47:5950%.
  • 48:00And there's been an increase of 19%
  • 48:03in referrals to psychiatric and
  • 48:05psychological services and maybe.
  • 48:08This is a result of having a decrease
  • 48:10in prescriptions for opioids,
  • 48:11which are down 8 to 14%.
  • 48:13Orders for injections are down
  • 48:15a little bit and interestingly,
  • 48:17orders for physical therapy
  • 48:18and occupational also down,
  • 48:19and we think it might be because they're
  • 48:21referring more to integrative medicine.
  • 48:23We also saw a decrease in the
  • 48:25number of ER visits and urgent care
  • 48:28visits per pain patient.
  • 48:30That doesn't mean these visits were
  • 48:32not necessarily related to a pain
  • 48:34issue that they were experiencing.
  • 48:36And so it's just an observation.
  • 48:38That we've made.
  • 48:39But this is a true implementation project.
  • 48:42This is, there's nothing controlled here,
  • 48:44there's no research staff.
  • 48:45This is just the use of strategies to try
  • 48:49to increase the uptake of something that
  • 48:51we think will work to change practice
  • 48:54behavior and change prescribing behavior.
  • 48:56And all built on the formative evaluations
  • 48:59and process evaluations that we're
  • 49:01doing to learn what's working and
  • 49:04what's not working in the clinics.
  • 49:06And so the final strategy is that we need
  • 49:10to tailor our dissemination efforts more.
  • 49:11And this will really help address the
  • 49:14Chalmers comment of having unbiased
  • 49:16and usable research reports like
  • 49:17what can we create for the different
  • 49:20audiences and the different groups who
  • 49:23need to know more about our efforts
  • 49:25to decide that they also want to
  • 49:28adopt it and invest in this.
  • 49:30And I just will say that Yale
  • 49:33has a terrific dissemination.
  • 49:34I don't know what you call it,
  • 49:37a report, a report on strategies,
  • 49:41but I use this all the time.
  • 49:43I share it with lots of people.
  • 49:45If you aren't familiar with this,
  • 49:46it's it's the link is there
  • 49:48and I will share these slides.
  • 49:49But really talking about these key
  • 49:51characteristics of an effective
  • 49:52dissemination plan and that number one,
  • 49:54is super important to orienting towards the
  • 49:56needs of the audience using appropriate
  • 49:59language and information levels.
  • 50:00And when we are thinking about this,
  • 50:02a quarry project that we just completed
  • 50:04and how can we start to convince people
  • 50:07that they can add these questions,
  • 50:09these treatment expectancy, excuse me,
  • 50:11expectancy, positive outlook,
  • 50:14patient provider relationship
  • 50:16questions in a way that may inform
  • 50:19the conversations that providers and
  • 50:22patients are having and may inform future
  • 50:25treatments moving away from opioid use,
  • 50:27moving into non pharmacological
  • 50:28treatments we think well what is it?
  • 50:30That a clinic needs to know what is
  • 50:32it that leadership needs to know
  • 50:34and we're talking to, you know,
  • 50:36small, you know,
  • 50:37small clinics around the country.
  • 50:38We're talking to larger hospital based.
  • 50:41What do they need to know?
  • 50:43And honestly what they need to know is
  • 50:46what are the costs of implementing this.
  • 50:49And luckily,
  • 50:50Lisa Saldana,
  • 50:50who's at the Oregon Social Learning Center,
  • 50:53has worked done a lot of work on
  • 50:55something called the stages of
  • 50:57implementation completion checklist,
  • 50:59which she has also shown can be
  • 51:01a way of tracking the costs of
  • 51:04implementing these strategies.
  • 51:05And these are the eight steps in an
  • 51:08implementation pipeline if you will.
  • 51:10First,
  • 51:10there's a pre implementation phase of
  • 51:13engagement understanding, feasibility,
  • 51:15readiness planning with a site.
  • 51:18So those are considered.
  • 51:19The first three steps are pre
  • 51:21implementation work and then so besides
  • 51:23done all that and they're ready to implement,
  • 51:26you can move to the implementation
  • 51:27phase which is we hire staff and train
  • 51:29them or we don't need to hire staff
  • 51:31but we move staff into certain roles,
  • 51:33we do some fidelity monitoring we.
  • 51:36Maybe the research team provides some
  • 51:37consultation to get started up and
  • 51:39maybe at that point then someone at
  • 51:40the site takes over that consultation,
  • 51:42working with the different groups of the
  • 51:44clinic on that implementation effort.
  • 51:46There's going to be some ongoing
  • 51:47monitoring of what's going on.
  • 51:49That's the implementation phase.
  • 51:50And then obviously we need to
  • 51:52understand has true competency been
  • 51:54achieved which can lead to sustainment.
  • 51:56Each of these eight steps requires the
  • 51:59research team to do a lot of tracking
  • 52:02of the different efforts involved in
  • 52:04every implementation to understand
  • 52:06what does engagement mean for me?
  • 52:08What does feasibility mean for me?
  • 52:10Who's involved with that?
  • 52:11But through this meticulous tracking,
  • 52:13and especially if you're working
  • 52:15with a champion like we were with
  • 52:17the head of the Pain Medicine Group,
  • 52:19we could start to identify what does
  • 52:20that mean in terms of minutes and what
  • 52:23does that mean in terms of costs for
  • 52:25the people who are working on this.
  • 52:27And so through a lot of work we did a cost,
  • 52:30we got an extension for Macquarie to do
  • 52:31a cost of implementation enhancement.
  • 52:33We tracked costs from March 1st
  • 52:35to November 30th of 2021.
  • 52:37We found that at this point
  • 52:39there were 24,000 patients.
  • 52:41This involved 74 clinic personnel.
  • 52:43We could figure out when people
  • 52:45moved from a pre implementation to
  • 52:47an implementation to a sustainment
  • 52:49phase in each of these clinics.
  • 52:51And then we also could figure out
  • 52:53who at each of the clinics was
  • 52:55working on this and so in general.
  • 52:57We collected costs that are going
  • 52:59to help a future clinic decide
  • 53:01do they want to invest in this,
  • 53:03what is this going to mean for
  • 53:05us at what's the bottom line.
  • 53:07And so looking at attending physicians,
  • 53:09mid level providers, nurse managers,
  • 53:11nurses etcetera,
  • 53:12including front desk staff
  • 53:14because they're very important.
  • 53:15We found that one hour of heal
  • 53:19implementation of tracking,
  • 53:21you know the input,
  • 53:22you know for everything from encouraging
  • 53:25people to complete the surveys sending out.
  • 53:28Survey links reminding them
  • 53:30downloading reports, looking at them,
  • 53:33having conversations, etcetera.
  • 53:34But that was about $572 per hour.
  • 53:39Per clinic and a 10 minute increment for
  • 53:42all clinic staff is about $95 because
  • 53:44not everything happens in an hour time,
  • 53:46sometimes just little bits and pieces,
  • 53:48which means that a total implementation
  • 53:51cost for heal is about $28,000.
  • 53:53And so this is now something that we
  • 53:56can disseminate to clinics to think
  • 53:59about is this worth your investment
  • 54:02and if people think about what having?
  • 54:05Patients use opioids has led to and
  • 54:08what that crisis is like and what
  • 54:10they might be saving elsewhere.
  • 54:12This is the kind of decision making
  • 54:14that can happen in terms of deciding
  • 54:16whether or not to adopt or not
  • 54:17adopt an innovation or in this
  • 54:19case an evidence based practice.
  • 54:21So in summary,
  • 54:22we've talked about a lot of things that
  • 54:24can address the implementation gap and
  • 54:26reduce waste and research by increasing
  • 54:28uptake of evidence into the community.
  • 54:30We talked about using hybrid study designs,
  • 54:33be guided by theory,
  • 54:34get to know your stakeholders and
  • 54:36tailor your dissemination efforts.
  • 54:38And throughout it all,
  • 54:40we hope that HealthEquity can be achieved
  • 54:42through using pragmatic real-world research.
  • 54:45Few, if any exclusions, we take all comers.
  • 54:49Research is meaningful to the end users.
  • 54:51Adaptation needs are considered
  • 54:53at the beginning so that we're
  • 54:55not implementing something that
  • 54:56isn't going to work in real world.
  • 54:59And we also can start to
  • 55:00incorporate new ways of thinking,
  • 55:01and I didn't really talk about this yet,
  • 55:02but this is what is going on right now
  • 55:04in the HealthEquity space is how can
  • 55:06we take the existing theories that
  • 55:07we have and just and just incorporate
  • 55:09new ways of thinking into them.
  • 55:11So if we're thinking about did we reach
  • 55:13people we can think about or who's adopting,
  • 55:16we can answer ask questions that have
  • 55:19a HealthEquity perspective to them.
  • 55:21So did all settings equitably
  • 55:22adopt the intervention?
  • 55:24Are the health impacts that we
  • 55:25see equitable across all groups?
  • 55:27Are all populations?
  • 55:28Equitably reached by this intervention.
  • 55:31So just taking our theory but thinking
  • 55:33about them in new ways in which we
  • 55:35can achieve HealthEquity and that's
  • 55:37definitely something a goal for me.
  • 55:39I'm not yet there trying to do that
  • 55:41with like current projects and hope it
  • 55:44becomes something that we do all the time.
  • 55:47And with that, I'll stop.
  • 55:48Thank you very much.
  • 55:50Thank you so much.
  • 55:52Really enjoyed your presentation.