Implementation Science: lessons learned from LMICs and new challenges

Transcript

• 00:00(attendees chattering)
• 00:15(attendees chattering continues)
• 00:23<v ->Thanks.</v> <v ->Thank you for your help.</v>
• 00:28<v Donna>Hey, Ericka, how are you?</v>
• 00:31<v ->Good, how are you?</v> <v ->Good, thank you.</v>
• 00:33<v ->Hey-</v> <v ->So you must be Vilma?</v>
• 00:35<v ->Yes, I'm Vilma.</v> <v ->Hello,</v>
• 00:37my name is Luke Davis.
• 00:38Nice to meet you. (laughs) <v ->Hello, Spanish... (laughs)</v>
• 00:41<v ->Yeah, I just came to welcome you.</v>
• 00:44So I know trying set up with your presentation,
• 00:48but I would wanna have a chance to join you and Donna
• 00:50for dinner tonight?
• 00:52<v ->Oh, but not today.</v>
• 00:53I'm so late, so we can't have that now.
• 00:56<v ->I'd love to hear more-</v> <v ->We're working on many,</v>
• 00:58many things. <v ->I'd love to hear more,</v>
• 01:00and of course I'll learn a lot now,
• 01:01and I know you're doing a lot of education-
• 01:02<v ->Well, you know...</v> <v ->I just wanna...</v>
• 01:03<v Vilma>Yeah, that's good.</v>
• 01:05Some other time. <v ->Well, remember,</v>
• 01:07it's my treat. <v ->Okay, thanks very much.</v>
• 01:09I really appreciate. <v ->We're ready to turn,</v>
• 01:09so if you wanna go to the podium and choose-
• 01:12<v ->Oh, I see.</v> <v ->You have to do it</v>
• 01:13at the podium, yeah. (laughs) (Vilma laughing)
• 01:15<v Vilma>All right, I'll go to the podium then. (laughs)</v>
• 01:17<v ->Oh, okay. (Vilma laughing)</v>
• 01:24<v ->So are you ready?</v> <v ->Yeah.</v>
• 01:28<v Donna>It's only 12:01.</v>
• 01:29We usually give people a little more time
• 01:30to arrive. <v ->Okay, I mean, that's good.</v>
• 01:36<v ->Yeah, we usually do.</v> <v ->Okay.</v>
• 01:41<v Donna>Hmm...</v>
• 01:41(papers rustling)
• 01:47Do you want me to put it in the chat
• 01:48that we'll start in about five minutes?
• 01:50<v Ericka>I can be do that now.</v>
• 01:52<v Donna>Can they hear us right now?</v>
• 01:54<v Ericka>Yeah, we're not muted.</v>
• 01:56<v ->Okay, yeah, so hi, everyone.</v>
• 01:57We're just gonna give people a few more minutes to arrive.
• 04:52Hi, everyone, I'm Donna Spiegelman.
• 04:53I'm Director of the Center for Methods
• 04:55in Implementation and Prevention Science,
• 04:58and I'm very pleased today to introduce our speaker,
• 05:01Vilma Irazola, who is the Director
• 05:04of the South American Center of Excellence
• 05:07for Cardiovascular Health and the Institute
• 05:10for Clinical Effectiveness and Health Policy,
• 05:12both in Buenos Aires, Argentina.
• 05:15She's also deputy director
• 05:16of the master's degree program in Clinical Effectiveness
• 05:20at the University of Buenos Aires.
• 05:23She'll be speaking on, "Implementation Science:
• 05:25Lessons learned from low- and middle-income countries
• 05:28and new challenges."
• 05:30And I'm very pleased that this seminar
• 05:32is co-sponsored by Yale School of Public Health's
• 05:35Department of Chronic Disease Epidemiology,
• 05:38and by the Yale Institute for Global Health
• 05:41at the Yale School of Medicine,
• 05:43and by Cardiovascular Medicine
• 05:45at the Yale School of Medicine
• 05:46and finally, by our NIH T32 Training Grant
• 05:50in Implementation Science Research Methods from NHLBI.
• 05:57Vilma is a cardiologist and epidemiologist.
• 06:01Her research is focused on implementation science
• 06:04in the area of public health, health promotion
• 06:07and prevention and management of chronic diseases.
• 06:10She has been involved in the design and evaluation
• 06:13of community-based and primary care programs
• 06:16and interventions related to cardiovascular disease,
• 06:19diabetes and aging.
• 06:21In addition to her work in Argentina,
• 06:23where she also teaches
• 06:25Advanced Epidemiologic and Analytic Methods,
• 06:28she is Associate Professor of the Cross-Continental MPH
• 06:33at the College of Global Public Health at NYU,
• 06:36and a scholar and lecturer
• 06:37at the Harvard School of Public Health.
• 06:39I've known Vilma, I don't know, for how many years?
• 06:4115, 20, maybe more.
• 06:44We originally met at Harvard
• 06:46in connection with the Lown Scholars Program,
• 06:48among other things, and I think the last time I saw her
• 06:51was in Guatemala before COVID,
• 06:54where we were both working in a consortium of projects
• 06:58to scale up and implement cardiovascular disease prevention,
• 07:04screening and treatment programs around the world,
• 07:07a consortium that was sponsored by NHLBI.
• 07:12So I'm happy to turn things over to Vilma,
• 07:14and I'm looking forward to your talk.
• 07:17<v ->Thank you.</v>
• 07:18Thank you, thank you very much, Donna.
• 07:20And thank you for invitation
• 07:22and for this opportunity to share some topics
• 07:27that we are working on and to listen to you
• 07:30and your experiences as well.
• 07:34So for today,
• 07:35I will share a brief presentation
• 07:40about some topics that I'd like to share with you today,
• 07:44and I will share my screen in a minute.
• 07:52Oh, there it is.
• 08:05Okay, so what's the idea today?
• 08:11What's the topic?
• 08:13This morning actually, Donna and I
• 08:15were talking about some aspects
• 08:17that are so relevant for our work in implementation science,
• 08:22and about which we don't have, still,
• 08:28maybe all the methods and tools
• 08:30that we may need to approach that.
• 08:33So the idea is, today,
• 08:35to talk about the role of the control group
• 08:37and how to evaluate the control group
• 08:40in our implementation science studies,
• 08:44the role of context evaluation in this approach
• 08:48and the concept of usual care and enhanced usual care
• 08:53in our project.
• 08:55To do this, I will use two examples from our work
• 09:01in Argentina connected with hypertension control.
• 09:05These are two cluster-randomized controlled trials
• 09:09that we have conducted.
• 09:13One of them is finished and the other one is ongoing.
• 09:22Well, in terms of context evaluation,
• 09:25we all are familiar with the different frameworks
• 09:28that we usually use to approach this topic,
• 09:32like CFIR, for example,
• 09:35which is one of the first ones that approach, in depth,
• 09:41the evaluation of outer and inner settings.
• 09:47I am sure you are also familiar
• 09:49with the RE-AIM-PRISM framework, you know,
• 09:52that Dr. Glasgow, who is the developer of the framework,
• 10:04I'd say expanded this framework into RE-AIM-PRISM
• 10:14to include more aspects related to the context evaluation
• 10:20for this framework,
• 10:22which in the past was more focused
• 10:25only on evaluation and the different aspects of evaluation,
• 10:31in terms of reach, effectiveness,
• 10:33adoption, implementation among many.
• 10:36With RE-AIM-PRISM. we working today several projects
• 10:40in Argentina and Brazil and Guatemala,
• 10:45and we find it really useful
• 10:47for all these other topics that were added
• 10:50to the original RE-AIM framework.
• 10:53And also, I'd like to share with you this framework,
• 10:57which is the CIIP.
• 11:00This is a framework that, as far as I know,
• 11:04is not very commonly used in implementation research,
• 11:08it is more commonly used in training,
• 11:11in training projects and programs.
• 11:15And I think that there are several things in this framework
• 11:18that may be useful for us, as implementation researchers,
• 11:22to adopt and to incorporate to our methods.
• 11:27And one thing that I find really interesting about CIIP
• 11:33is that the context evaluation,
• 11:35which is the first step in this framework,
• 11:39is then translated into the different stages
• 11:43in the framework.
• 11:45So according to this framework,
• 11:47we keep evaluating the context throughout the project.
• 11:52In this case, they are usually education
• 11:55or training projects, but the proposal here
• 12:00is to keep evaluating these dynamic contexts
• 12:05throughout the project and beyond.
• 12:08So that's something that might be really useful
• 12:12and interesting for us as implementation researchers.
• 12:19And this brief introduction about context evaluation
• 12:23is connected with the role
• 12:26that this type of evaluation might have
• 12:32in the description and approach
• 12:37to the definition of usual care or enhanced usual care
• 12:41in our project.
• 12:43And to go into this topic,
• 12:45I'd like to share with you an example of a trial,
• 12:50a cluster-randomized controlled trial,
• 12:52that we conducted in Argentina a few years ago.
• 12:57It was about testing a comprehensive intervention
• 13:03for improving hypertension control
• 13:06in vulnerable population in our country.
• 13:11You know that hypertension is a leading global risk factor
• 13:15for cardiovascular disease and death,
• 13:19and about 75% of people with hypertension
• 13:26live in low- and middle income countries.
• 13:30And this, again, is pre-pandemic.
• 13:32After the pandemic, it's even worse.
• 13:38The other thing that is very important and critical for us
• 13:41is that less than 10% hypertensive patients in our countries
• 13:47are under control,
• 13:49or have their blood pressure under control.
• 13:53In the case of Argentina,
• 13:56the control rate is about 18%,
• 14:00according to our last estimations, again, pre-pandemic.
• 14:06We have some data from 2021 and early this year
• 14:12which indicates that the control rate is even worse.
• 14:19Well, so briefly,
• 14:22in this trial we selected 18 primary care clinics
• 14:27in different provinces in the country,
• 14:31and included participants who were adults with hypertension,
• 14:38who were really controlled,
• 14:40and defined full control of hypertension
• 14:45as having a systolic blood pressure
• 14:47of 140 millimeters of mercury, or above that number,
• 14:54and/or a diastolic blood pressure
• 14:57of 90 millimeters of mercury.
• 15:01We included these patients,
• 15:04their spouses, with or without hypertension,
• 15:07because part of the intervention
• 15:10was related to the role of peers,
• 15:14family members and people living
• 15:17with these hypertensive patients,
• 15:19and also, any other adult hypertensive family member
• 15:24living in the same household.
• 15:27That was the population of the study.
• 15:31And this is, again, briefly the flow chart of the trial.
• 15:38We included 18 public primary care clinics
• 15:43that were randomized to the intervention or the control.
• 15:47And here is the topic, the control arm.
• 15:50We conducted measurements at baseline six, 12 and 18 months,
• 15:58the outcomes of the study,
• 16:00for changes in systolic and diastolic blood pressure
• 16:05and hypertension control rate at 18 months.
• 16:12And this is a summary of the intervention.
• 16:15We defined three main components.
• 16:17The most important one was connected
• 16:20with the role of community health workers
• 16:24working as part of the primary care team
• 16:28and working with the participants, with the patients,
• 16:32at their homes.
• 16:34In this intervention,
• 16:36community health workers visited patients at their homes,
• 16:42working with their family as well.
• 16:45Patients were provided with BP monitors
• 16:49to self-monitor their blood pressure.
• 16:53Community health workers trained them
• 16:56on how to use these devices
• 16:59and to monitor their blood pressure.
• 17:03They, community health workers,
• 17:05also provided information and tools,
• 17:09different tools to improve medication adherence
• 17:14and lifestyle modifications.
• 17:17So mainly this part of the intervention was very important
• 17:22and was led by community health workers
• 17:27that were trained to do that.
• 17:31The other component was an mHealth component.
• 17:35We sent messages, text messages,
• 17:39to participants about lifestyle modifications,
• 17:44mainly diet and physical activity, that was the focus,
• 17:49and again, medication adherence.
• 17:53And the third component was directed to physicians,
• 18:00primary care physicians.
• 18:03Primary care physicians were trained
• 18:06in the use of clinical practice guidelines
• 18:09and they also received information, feedback,
• 18:14about the blood pressure values of their patients.
• 18:20What they did when they saw the blood pressure values
• 18:30of their patients was something that they decided
• 18:35by their own.
• 18:38Apart from an initial training on the use
• 18:42and contents of clinical practice guidelines,
• 18:46we did not do anything else with decisions.
• 18:50So they decided what to do, how to manage their patients,
• 18:55but they received this information
• 18:58that is not part of the initial care.
• 19:02<v ->Vilma, I have a question.</v> <v ->Yes.</v>
• 19:03<v Donna>Can you say</v>
• 19:04what blood pressure audit and feedback is?
• 19:07<v ->Yes.</v> <v ->That's the second component.</v>
• 19:10<v ->Yes, that's the second component.</v>
• 19:13What we did is the community health worker
• 19:18visited patient's home each month
• 19:21during the first six months, and then bimonthly.
• 19:25When they went to a patient's home,
• 19:29they reviewed, with the patient,
• 19:31all the values of their blood pressure,
• 19:35according to a log
• 19:37that the participants were asked to complete.
• 19:42And that information was shared
• 19:45by the community health worker with the physician.
• 19:49That's the feedback,
• 19:50that's the component of sharing data with the physician.
• 19:57And that's all what we did in that component.
• 20:04Some physicians were very proactive,
• 20:07and they take action and adjust medication, et cetera,
• 20:11and others not.
• 20:13We haven't had nothing to do directly
• 20:17through the trial with that.
• 20:20So that was that component.
• 20:24And it's important to your question, Donna,
• 20:26because at the time,
• 20:27there were no electronic medical records in these clinics.
• 20:32Now, in these provinces, the situation is different,
• 20:36so we would be able to do this differently now.
• 20:42And I can tell you what's happening now
• 20:45in these provinces as well.
• 20:49Well, so these are briefly the three components
• 20:54of the intervention.
• 20:57This is, for example, a picture of the training sessions
• 21:03for community health workers at the university,
• 21:09and these are some examples of the tools
• 21:13that the community health worker share with participants,
• 21:18for example, pill boxes,
• 21:23to help improving adherence to medication
• 21:28and other tools that they share with patients as well.
• 21:37They, community health workers, trained participants
• 21:41on how to measure and monitor their blood pressure as well.
• 21:49And everything happened at home.
• 21:54Well, some of the results, what happened with this trial?
• 22:00In this table,
• 22:01we describe the main characteristics of our participants.
• 22:06As you can see, the mean age was around 56 years old,
• 22:16half of them were women
• 22:19and what else I'd like to highlight here
• 22:24were patients were poorly controlled,
• 22:26that was a criteria to enter the study.
• 22:30You can see also in this table
• 22:32that the use of antihypertensive medication was very high.
• 22:38This is the public system in Argentina
• 22:42and medication is provided for free to patients.
• 22:48The problem is that there are periods of time
• 23:01where the centers don't have enough medication
• 23:04for patients.
• 23:05That's very frequent, that's very frequent.
• 23:08So in spite of being a high percentage,
• 23:11high proportion of patients being treated,
• 23:15the problem here was more connected
• 23:18with continuity of treatment,
• 23:23in part because of lack of medication during some months.
• 23:28<v Donna>Can I make a comment right here on this?</v>
• 23:30<v ->Yes, sure.</v> <v ->So I see that you</v>
• 23:31sort of started off in a bad-luck situation,
• 23:34where the intervention group
• 23:37had significantly higher history of CVD
• 23:41and higher systolic and diastolic blood pressure.
• 23:43It's not huge differences,
• 23:46but usually with sample sizes like that,
• 23:48you don't see significant differences in a randomized trial.
• 23:51<v ->Yeah.</v> <v ->But maybe it's because</v>
• 23:53of the cluster randomization and there might have been...
• 23:56I don't know what the ICC was with the clusters,
• 23:59but maybe there was a lot of variation in the clusters,
• 24:03so that it's much easier to have a bad-luck randomization
• 24:08like this. <v ->Yes.</v>
• 24:09It was just like that.
• 24:12And in our calculation, our sample size,
• 24:19we estimated an ICC of 0.06,
• 24:22that was our sample size calculation,
• 24:25but then, after conducting the trial,
• 24:29the actual ICC was 0.15.
• 24:33<v ->Wow, yeah that is-</v> <v ->It was very high.</v>
• 24:36It was very high.
• 24:39Well, so this is the population
• 24:44and what happened with our outcomes,
• 24:47systolic, diastolic blood pressure and hypertension control.
• 24:53Before going into that,
• 24:55I'd like to remind you that...
• 24:59Or not remind, I think I didn't say it.
• 25:02I think I didn't say it.
• 25:04If can go back to the previous slide...
• 25:14But it doesn't matter.
• 25:17One important thing here, in terms of our topic today,
• 25:20which is the control group
• 25:22and how to evaluate the control group,
• 25:25is that we conducted evaluation visits,
• 25:29study evaluation visits, at baseline six, 12 and 18 months.
• 25:36And who conducted those visits?
• 25:40We trained the study nurses
• 25:43who were part of the medical staff
• 25:46of the primary care team in each clinic,
• 25:52that is, the nurses in charge of conducting
• 25:57the evaluation visits were part of the primary care team.
• 26:02And this is important later
• 26:05for the interpretation of our results.
• 26:08<v Attendee>Vilma, are you saying that...</v>
• 26:10Was that by design or in retrospect?
• 26:13Maybe you wouldn't have preferred that?
• 26:14I mean, it seems like if they're part of the group,
• 26:17it might be hard for them to be objective.
• 26:18Is that the point that you're making?
• 26:21<v ->Yes, yes.</v>
• 26:23Yes, but it was so by design really,
• 26:27because in my view, there is a trade-off here, you know?
• 26:31This is very warm, our population.
• 26:34So sometimes it's difficult to enter
• 26:38in the neighborhood and be accepted by people.
• 26:42People have to open their door
• 26:45for you to conduct these evaluations,
• 26:50and for them, it's very important
• 26:53that they know these people.
• 26:58So we thought a lot about that and said,
• 27:02"Well, we can hire nurses
• 27:05and do this absolutely independent of the primary care team,
• 27:10but in our opinion,
• 27:13it would have been very difficult
• 27:15for them to enter many of these houses."
• 27:18So we say, "Well, we trained, in depth and intensively,
• 27:26these nurses on how to make the evaluations,
• 27:32how to collect the data.
• 27:34They were trained not to do anything else
• 27:38when they conducted these evaluation visits,
• 27:42but they were part of the primary care team,
• 27:45and people know that, so that's important, yeah,
• 27:51Well, what happened then with our outcomes?
• 27:56We can see here the effect of the intervention
• 27:59on systolic blood pressure.
• 28:01There was a significant reduction in the intervention group
• 28:10early at six months, and this effect was present
• 28:17until the end of the study as well.
• 28:19So we have these positive results,
• 28:22in terms of systolic blood pressure.
• 28:25But if you look at the control group here,
• 28:29the control group also presented improvement
• 28:38in the systolic blood pressure of their patients.
• 28:43And the same happened with diastolic blood pressure.
• 28:48The reduction was significantly different
• 28:51between the two groups,
• 28:53but again, in the control group,
• 28:56there was an improvement, a significant improvement,
• 29:00within this arm.
• 29:03And same thing when we look
• 29:07into the proportion of participants
• 29:10with their blood pressure under control.
• 29:15Again, the difference was significant between the arms,
• 29:21but there was improvement in the control group.
• 29:30Well these are some data about mediators,
• 29:34like adherence to medication, which was improved over time,
• 29:41and the same happened with adjustment of medication
• 29:48by physicians.
• 29:53And here we come to the topic now
• 29:55that we want to discuss today.
• 29:58There was this improvement in the control group,
• 30:02and trying to interpret, the best way we can, these results.
• 30:06So we conducted several in-depth interviews
• 30:10with participants from the control group.
• 30:19Usually we conduct interviews
• 30:24with a particular focus on participants
• 30:28in the intervention group, you know?
• 30:31Because we want to learn about the perceptions
• 30:34about the intervention,
• 30:36whether it was more appealing for patients or not,
• 30:41and things like acceptance and other topics.
• 30:45We pay a lot of attention usually to the intervention group,
• 30:51and we do, wrongly, less work with the control of our study.
• 30:59In this case, and seeing those results,
• 31:03we conducted these interviews,
• 31:06and we found that first,
• 31:08patients valued, really, being visited by nurses
• 31:13from their clinics, from their primary care centers.
• 31:19They felt care, you know?
• 31:23They valued that and that was something positive for them
• 31:27and for their own healthcare.
• 31:31The other thing that happened
• 31:33was that nurses provided some counseling, you know?
• 31:39I mean, they were in contact with these patients,
• 31:42they knew them and they provided counseling about,
• 31:48for example, how to get medication.
• 31:50You have travel when you go to the primary care center.
• 31:54What can you do?
• 31:55"I can help you with this," and comments of this kind.
• 31:59And the nurses did that and that's a great thing, of course,
• 32:05that help us understand better the results.
• 32:10Patients in the control group increased the number of visits
• 32:15to the clinic, for example, without any other intervention
• 32:20but these visits, these evaluation visits.
• 32:27So we know all these aspects
• 32:30because of this qualitative approach.
• 32:32It was a very limited qualitative approach
• 32:36that we were able to do in this case,
• 32:41but my question for you, and my reflection on that,
• 32:46is how to better design the qualitative phase,
• 32:52the qualitative components of our research,
• 32:55to get information,
• 32:57not only on the intervention perceptions,
• 33:00the intervention group, et cetera,
• 33:02but also what is happening with the usual care group,
• 33:07or standard care group,
• 33:09and what people in this arm feel and is exposed to
• 33:14during the study in general.
• 33:18And the other thing
• 33:19that I was talking to Dr. Raphael yesterday
• 33:24was about the use of existing databases
• 33:28to get information about not only the control arm,
• 33:33but all the other centers
• 33:35that are a part of our target population, and therefore,
• 33:39not included in the study,
• 33:41because that would be usual care, really.
• 33:45And I was talking with Donna this morning,
• 33:47how to incorporate those things, if those data exist,
• 33:53how to incorporate them to better understand
• 33:56what is usual care of centers
• 34:00that are not part of a clinical trial,
• 34:03like in this case, for example.
• 34:05So that's something that we can study and develop, you know,
• 34:14in that type of approach.
• 34:16We're trying to do that
• 34:18in another cluster-randomized controlled trial
• 34:21that we are conducting now in Guatemala.
• 34:25Based on these results,
• 34:29we started a new project with our team in Guatemala.
• 34:34We adapted this intervention
• 34:37that I presented a few minutes ago
• 34:42to the context of Guatemala.
• 34:46There were a lot of adaptations,
• 34:48and we don't have time today to go into much detail,
• 34:52but we designed,
• 34:53in this cluster-randomized controlled trial in Guatemala,
• 34:56we included 32 primary care clinics
• 35:04in different districts in Guatemala,
• 35:07and they were randomized to the intervention
• 35:11or the usual care arm of the study.
• 35:17And the intervention, as I said before,
• 35:20was based on the experience in Argentina,
• 35:23but we did a lot of adaptations.
• 35:26These are the final components
• 35:28of the intervention in Guatemala.
• 35:31<v Donna>How was it adapted?</v>
• 35:32It kinda looks the same to me.
• 35:34<v ->I'm sorry?</v> <v ->How was it adapted,</v>
• 35:36because it looks very similar, or even the same,
• 35:39as the Argentina intervention components?
• 35:42<v ->Yes, there are a lot of similarities,</v>
• 35:44there are a lot of similarities.
• 35:46But for example, the mHealth component,
• 35:49which was text messages in Argentina, is not here,
• 35:54is not part of the trial in Guatemala,
• 35:56because of the very high proportion of illiteracy
• 36:02in Guatemala.
• 36:04So there is a high proportion of people
• 36:07who cannot read and write,
• 36:11so we did a lot of work trying to adapt, with visual aids,
• 36:18the messages, but we didn't find a way
• 36:23to make it feasible here,
• 36:26so that's not part of the trial.
• 36:30There, home blood pressure monitoring is quite the same.
• 36:35What we adapted here is the training,
• 36:40or the education of patients,
• 36:42on how to use these devices,
• 36:45again, for the same reason.
• 36:46So we used pictures, for example, for patients
• 36:51and we did a lot of training with the patient,
• 36:55just to be sure that they were able to use those devices.
• 37:03And here, about the team collaborative approach,
• 37:07in Guatemala, the system is organized in a different way,
• 37:12compared to Argentina,
• 37:15so we have to work with more levels.
• 37:20For example, in this clinic, there is no doctor.
• 37:25In Argentina, each primary care clinic
• 37:29has a primary care team with at least a doctor,
• 37:33in general, a general practitioner,
• 37:36one nurse and one community health worker.
• 37:39That's more or less a rule,
• 37:41and in some clinics there are more people and more doctors
• 37:47or nurses or community health workers.
• 37:51In Guatemala, in each clinic,
• 37:53there is one auxiliary nurse at least,
• 37:57and maybe that's the only personnel at the clinic.
• 38:02In the higher level of clinics,
• 38:07they have also a nurse,
• 38:10and then they have centers where they have doctors.
• 38:16These are interconnected,
• 38:19but you have to work with these different pieces.
• 38:22So this collaborative team approach was different
• 38:27as the ones in Argentina.
• 38:30A lot of other things are very similar, very similar.
• 38:36So this is the intervention in Guatemala.
• 38:39In Guatemala, and this maybe is a topic for another meeting,
• 38:46we have other types of challenges
• 38:49connected with the different ethnic groups.
• 38:54In Guatemala, there are many different populations,
• 39:01that, for example, some of them speak Spanish,
• 39:07some of them are bilingual,
• 39:09so they speak Spanish and a Mayan language,
• 39:13and some of them speak only in Mayan languages,
• 39:18and some Mayan languages have a written form and others not.
• 39:25So there we have another very, very challenging situation
• 39:32and we work a lot with the materials
• 39:35and according to these different populations.
• 39:39(participants speaking in foreign language)
• 39:55(participants speaking in foreign language continues)
• 40:08Okay, so well, this is study in Guatemala
• 40:15and the field work.
• 40:20Equity, this is another topic. (laughs)
• 40:22This is another big topic.
• 40:30So what's the state of the study in Guatemala?
• 40:35We finished the field work last week,
• 40:40so we are just starting cleaning the database
• 40:44and preparing it for analysis.
• 40:47We will have the results in a few months,
• 40:49so we can share those results with you,
• 40:54but what I'd like to share here,
• 41:01in terms of the control group
• 41:02and how to approach the control group,
• 41:05is based on our learnings from Argentina,
• 41:09from the design phase of the study
• 41:12planned for different evaluations,
• 41:16not only of the control arm of the trial,
• 41:20but also on other clinical posts and centers
• 41:25that were not included in the study,
• 41:28so I hope we have more data to evaluate this usual care
• 41:33at the end of this study.
• 41:36And this has also budget implications.
• 41:39So for us researchers,
• 41:40it is important to have that in mind
• 41:43and plan in advance,
• 41:45because it's different, it's really difficult,
• 41:48in particular if,
• 41:50as it happens in Guatemala and in many other countries,
• 41:55information is not so easily obtained,
• 41:58and it's not so easy to access this information
• 42:03from other centers.
• 42:04So there is a lot of work there as well.
• 42:08So that's what I'd like to share with you
• 42:15and to put on the table, you know?
• 42:18What can we do as researchers to improve our study
• 42:23and evaluation of the so-called usual care in our studies.
• 42:30Yes? <v ->That was a wonderful talk.</v>
• 42:32You talked a little bit with the first study in Argentina
• 42:35about some of your hypotheses
• 42:37about the improvement in the control group
• 42:39with regards to these individuals making house visits.
• 42:42I was also interested in to what degree, in either study,
• 42:46there might be cluster-level differences
• 42:49between the different clinics that you're randomizing,
• 42:52and whether you account for those when you do randomization,
• 42:56say by stratified randomization or restricted randomization,
• 43:01if you think those factors
• 43:03might lead to systematic differences between the two groups?
• 43:08That's something that I've struggled a lot with
• 43:10in my research and I'm curious how you think about it.
• 43:13<v ->That's a great question.</v>
• 43:15We struggled (laughs) a lot as well.
• 43:17We have eligibility criteria for the individuals,
• 43:21I showed you those criteria,
• 43:23but also for the clinics, trying to, you know,
• 43:26have a set of...
• 43:28I mean, trying to reduce variability between the clinics
• 43:32that we invited to participate in the study.
• 43:36So that was one thing,
• 43:39in terms of resources, size, et cetera.
• 43:44The other thing is that we live in a federal country,
• 43:48so each province in our country, in Argentina,
• 43:52has their own rules, regulations
• 43:58and let's say, organization of the healthcare system.
• 44:03So yeah, we were working with several provinces
• 44:06in the country, so we stratified by province, for example,
• 44:10to take into account that,
• 44:13to try to adjust for that variable.
• 44:18And there was no other stratification in this trial.
• 44:23We tried to manage variability
• 44:27through this eligibility criteria, in terms of...
• 44:31I don't remember exactly,
• 44:33I think it was three or four variables,
• 44:37factors we took into account.
• 44:39One was size of the clinic,
• 44:45the composition of the primary care team in each clinic,
• 44:50not to mix, you know, maybe big clinics
• 44:53with a lot of personnel,
• 44:56versus other ones that were smaller,
• 45:00so we took that in account,
• 45:04provision of medication, because although medication
• 45:10is provided for free in our country,
• 45:13for people who has only public insurance,
• 45:18only public insurance and not other type of coverage,
• 45:23the quantity and delivery of medication is different
• 45:28from different clinics or districts within each product.
• 45:34So we took that in account as well.
• 45:36That was another way of trying to balance clinics
• 45:43before randomization.
• 45:46And after that, it was simple randomization of clinics,
• 45:49stratified by province and no more than that.
• 45:53But I agree with you, I agree with you.
• 45:55It may be for sure something that could have influence
• 46:03in these differences that we found.
• 46:09It's always difficult.
• 46:10In implementation research,
• 46:11you know that it's always difficult,
• 46:13this balance and this trade-off,
• 46:16between what is feasible and what we,
• 46:21from a design point of view, want for our trial.
• 46:26It's difficult, really.
• 46:28<v Donna>One suggestion on a statistical level</v>
• 46:31for this issue would be secondary analysis,
• 46:35where you control for baseline patient
• 46:38and clinical-level characteristics,
• 46:40and then see how that changes the contrast.
• 46:45<v ->That's a great subject.</v>
• 46:46Yes, we explore.
• 46:48<v ->Yeah, exactly.</v> <v ->We explored that,</v>
• 46:51and we didn't find any difference.
• 47:00We didn't have much data, you know,
• 47:03just in terms of the clinics,
• 47:06but we did exploration about that.
• 47:09We didn't find differences in the results.
• 47:19So that's something that I proposed to work on
• 47:23in the future.
• 47:24<v Donna>I'm curious, Vilma,</v>
• 47:28has the TREIN/HyTREC consortium discussed this issue at all?
• 47:32Have the other projects also seen the same sort of,
• 47:36maybe not necessarily in the same magnitude,
• 47:39but the direction of improvements in control groups?
• 47:44Like, was it a consortium-wide phenomena?
• 47:46Do we know?
• 47:48<v ->No, I don't know, but it hasn't been discussed yet.</v>
• 47:54We have a meeting in September, I think,
• 47:57and our idea is to share these results
• 48:01and see what is happening
• 48:03in other studies in the consortium,
• 48:06but it hasn't been discussed yet.
• 48:10<v Donna>I know we've seen a similar phenomena</v>
• 48:13in our work site intervention studies,
• 48:15where we're trying to improve food
• 48:17and physical activity environment at work sites,
• 48:20to reduce cardiometabolic risk,
• 48:23and then we find, just simply by screening
• 48:26and then waiting six months,
• 48:29we see big improvements in blood pressure
• 48:32and smaller ones in blood sugar and so forth,
• 48:35which I think has been seen.
• 48:37Like, screening itself is a public health intervention,
• 48:40but I've also read it's not a durable one,
• 48:44without additional supports.
• 48:46So you might see some additional...
• 48:48People may improve when they find out,
• 48:50but then, they'll go back, maybe,
• 48:52if we don't have these other things.
• 48:54So there's maybe short-term...
• 48:55Like, would the short-term improvements in the control group
• 49:00be sustainable, say for two years or five years,
• 49:04or would they start to go away,
• 49:05whereas the intervention group
• 49:07can maintain their improvements
• 49:09and maybe even continue to improve?
• 49:12<v ->I agree.</v>
• 49:13I fully agree and I think that...
• 49:16Actually, we prepare a proposal to measure sustainability
• 49:22of the resource in Argentina and we didn't make it,
• 49:26but I think that that's something
• 49:29to talk with funders about, you know?
• 49:34Because there is a lot of effort and resources
• 49:37put in each of these trials that we conduct,
• 49:41and we don't know, in general, what happened half the time.
• 49:47I have some data about this trial in particular,
• 49:50because this program was adopted by one of the provinces
• 49:56and it was scaled up through the province,
• 50:01one of the province that I showed in the first map.
• 50:05So I have data on that,
• 50:08and they are very, very successful.
• 50:14That's good data.
• 50:16The difference is not so big as in the trial,
• 50:19as usual, but they keep improving.
• 50:23I don't know what happens in the other provinces,
• 50:26but I think that's something that would be really great
• 50:29if we can do that.
• 50:30In terms of the time,
• 50:32I mean, the timeline of our project,
• 50:35in general, we cannot do that.
• 50:38So it's time budget, but I think it would be great
• 50:45if, really, it's possible now,
• 50:47to see what happened with these.
• 50:51These programs, these projects,
• 50:54are adopted by the government.
• 50:57You have data afterwards, but if not,
• 51:01in general, it's difficult to know what happened.
• 51:09<v Donna>How did the randomization work out in Guatemala?</v>
• 51:13<v ->In terms of the clinic?</v> <v ->Of the balance?</v>
• 51:15Yeah, like, in table one, like you showed us-
• 51:19<v ->Yeah.</v> <v ->And did you</v>
• 51:20have significant differences between-
• 51:22<v ->No.</v> <v ->Oh, good.</v>
• 51:23<v ->No, it was better. (laughs)</v>
• 51:24In that sense, it was better. (Donna laughing)
• 51:26Yeah, it was more balanced. <v ->Uh-huh.</v>
• 51:28<v ->Yeah, and I don't have the table now,</v>
• 51:30but in Guatemala, it was more balanced.
• 51:32<v Donna>Uh-huh.</v>
• 51:33<v ->Yeah.</v>
• 51:36<v Donna>So I'm monitoring the chat,</v>
• 51:38and it seems that people are being a little shy.
• 51:41<v ->Oh, I have another question.</v> <v ->Oh, good.</v>
• 51:42(attendees laughing) I have some too,
• 51:43but I didn't wanna hog the whole discussion.
• 51:46<v Attendee>So do you know to what degree</v>
• 51:49the interventions worked in the intervention arm?
• 51:52Because I'm just wondering, A, how successful they were,
• 51:57or B, if there were other factors
• 51:59that restricted the ability to improve?
• 52:00For example, you were mentioning about a lack of medications
• 52:04in the health facilities.
• 52:05I can imagine that no matter what you do
• 52:07with all those interventions, if there aren't drugs,
• 52:09things might not get better.
• 52:11Do you have any information on the fidelity, basically,
• 52:13of the intervention,
• 52:15or factors that might have impeded the fidelity?
• 52:18<v ->Yes, we have...</v>
• 52:22We have quite a lot of information from the Argentina trial.
• 52:28But there is something I would like to comment
• 52:30connected with your question in Guatemala.
• 52:34In Guatemala, the Ministry of Health
• 52:39was part of the trial, of the project,
• 52:42from the very beginning.
• 52:44They were involved in the design of the intervention,
• 52:48in the monitoring of the intervention,
• 52:50so they were very much involved.
• 52:54And they committed themself to assure
• 52:59that there would be medication at the health posts
• 53:07at least during the trial or duration of the trial.
• 53:11And they did it.
• 53:13With some periods, you know,
• 53:15that they have problems, limitations,
• 53:18shortage of medication, but they did it,
• 53:21and they work a lot to provide medication
• 53:25and to prioritize these centers, part of the study,
• 53:30in the provision of medication.
• 53:35So something that we...
• 53:38Again, I don't have the data to talk about,
• 53:45but we know that there was improvement
• 53:52in both arms in Guatemala,
• 53:53something similar to what happened in Argentina,
• 53:58and through qualitative interviews,
• 54:00we understood that people was really very...
• 54:07I mean, they felt very well,
• 54:09because they noticed that there were medication
• 54:14at the centers, where in the past,
• 54:18maybe they have much more problem to get those medicines.
• 54:22That's something that all the participants said.
• 54:27So a very basic thing like having medication,
• 54:32access to medication, in the centers,
• 54:34that was something that was more or less assured
• 54:39in both arms of the study.
• 54:42But in our approach to the other centers in Guatemala,
• 54:47same district, same district, but not part of the study,
• 54:53we are collecting information about medication,
• 54:57and the lack of medication is very important.
• 55:04There were serious problems,
• 55:06serious problems with the provision of medication
• 55:09in all the other centers in the same district,
• 55:14different to the centers in the study.
• 55:21So that's something that if you cannot assure that,
• 55:24I mean, if you cannot provide medication,
• 55:27as you said, whatever you do with the other alternatives,
• 55:31that is just maybe useless.
• 55:35<v Donna>And was this in Argentina you're talking about?</v>
• 55:37Or Guatemala? <v ->Guatemala.</v>
• 55:39<v ->Okay.</v> <v ->In this case, Guatemala.</v>
• 55:43In this case, Guatemala, because in the preparation phase,
• 55:47in the pre-implementation phase of the study,
• 55:50we did a lot of research about what is happening
• 55:54with the availability of drugs in the centers,
• 55:58and we found that there were big problems there.
• 56:01So we talk with the Ministry of Health,
• 56:04they committed to work on that for these centers,
• 56:10for these clinics, and they did.
• 56:13But the rest, again, the usual care in reality in Guatemala
• 56:20was different.
• 56:21I don't know how much impact this will have
• 56:24on this trial yet.
• 56:26But it happened there.
• 56:28<v Donna>So Vilma, we've gotten...</v>
• 56:30It's like three questions now on the chat,
• 56:32and we only have two or three minutes,
• 56:35so what I thought I might do
• 56:37is just ask all of them in four minutes,
• 56:39I'd ask all of the questions,
• 56:41and maybe you can just try to address them together?
• 56:44<v ->Yes.</v> <v ->So John Roman asked,</v>
• 56:49"Was there any incentives given
• 56:51to either participants or care providers?"
• 56:53I think he means financial incentives-
• 56:55<v ->No, (laughs) a short question.</v>
• 56:58<v ->Okay, good-</v> <v ->A short answer. (laughs)</v>
• 57:00<v Donna>Oh, Raphael Perez Escamilla asked,</v>
• 57:02"Was text messaging used in Argentina and Guatemala
• 57:05as part of the intervention?
• 57:06If so, was it helpful?"
• 57:08You've actually addressed that a little bit,
• 57:10but maybe if there was data on...
• 57:12So Raphael, it wasn't used in Guatemala,
• 57:15because of the literacy issues,
• 57:17but in Argentina it was used,
• 57:19and I don't know, Vilma,
• 57:20if there was any way to independently look at that component
• 57:24to see how helpful it was,
• 57:25compared to all these other complex components?
• 57:29<v ->No, it's difficult to separate</v>
• 57:32and to analyze independently the contribution.
• 57:35But there was a high correlation
• 57:37with the dose received of text messages
• 57:41and the blood pressure control.
• 57:42<v ->Okay.</v> <v ->Okay, so that's something</v>
• 57:45that can be interpreted
• 57:47as these were a useful part of the intervention.
• 57:53<v Donna>Oh, good.</v>
• 57:53And then Anna Julio asked,
• 57:55"How sustainable is the intervention?
• 57:58Was it adopted by the Ministry of Health in total?
• 58:01Besides the medications, the mHealth component?"
• 58:04So I think you've discussed that a little bit
• 58:06maybe about Guatemala, but not so much for Argentina.
• 58:11<v ->In Argentina, the intervention was adopted</v>
• 58:13by only one province.
• 58:14<v Donna>Oh, that's right, you did say that.</v>
• 58:19<v ->And it's working. (laughs)</v>
• 58:20It's working, you know?
• 58:22But not in the other provinces.
• 58:24And shortly, this is the base for the HEARTS initiative.
• 58:29The HEARTS Initiative in the Americas,
• 58:31in the case of Argentina,
• 58:34was built on this intervention.
• 58:36So we could contribute, you know,
• 58:40with many implementation indicators
• 58:42for them to implement the initiative.
• 58:46That's something, not much, but something.
• 58:49<v Donna>Vilma, maybe like in your remaining few minutes</v>
• 58:51you could say a little bit more about the HEARTS Initiative,
• 58:54'cause a number of us, myself included,
• 58:56are not that familiar with it?
• 58:58<v ->The HEARTS Initiative is a platform initiative</v>
• 59:02for the Americas.
• 59:03There are 12 countries
• 59:04that adopted the HEARTS Initiative
• 59:08directed to better control hypertension,
• 59:12and HEARTS is based on a team-based approach protocol
• 59:16for clinical practice guidelines in the country,
• 59:21measuring cardiovascular risk
• 59:22as part of the management of patients with hypertension
• 59:27and providing free access to medication,
• 59:31in particular, fixed-dose combinations,
• 59:35which are supposed to improve adherence,
• 59:38because these people had and have comorbidities
• 59:41and sometimes have to take many medications,
• 59:44so these fixed-dose combinations are an alternative.
• 59:50Those are the components of the HEARTS Initiative
• 59:54in the Americas, and we have 12 countries at the moment
• 59:57as part the initiative.
• 59:59<v Donna>And who's paying for all these medications?</v>
• 01:00:02<v ->Each government.</v>
• 01:00:03I mean, each government.
• 01:00:04They don't receive...
• 01:00:06Countries don't receive any financial support.
• 01:00:11Technical support, yes, but not financial.
• 01:00:17<v Donna>Okay, well, it is 13:00,</v>
• 01:00:19so this was an incredibly interesting talk.
• 01:00:23I would've loved to have asked more about equity,
• 01:00:25which is a very hot topic around here
• 01:00:27at the Yale School of Public Health and elsewhere,
• 01:00:30but maybe we can save that for another time.
• 01:00:33And thank you so much, Vilma,
• 01:00:34for coming and providing such amazing information.
• 01:00:40<v ->Thank you very much.</v>
• 01:00:42Thank you very much for giving me the opportunity.
• 01:00:45<v ->Yeah.</v> <v ->You are like a star.</v>
• 01:00:47(attendees laughing) <v ->Thank you.</v>
• 01:00:49(attendees chattering)
• 01:00:54<v Luke>Hey, how's it going, I'm Luke Davis.</v>
• 01:00:55<v Attendee 2>Hi, how are you?</v>