Implementation Science: lessons learned from LMICs and new challenges

July 07, 2023

Information

Speaker: Vilma Irazola

Thursday, 2022, June 9 at 12 pm EST

CMIPS virtual seminar Co-sponsored by the Department of Chronic Disease Epidemiology, Yale School of Public Health, and by the Yale Institute for Global Health (YIGH), Yale School of Medicine, and by Cardiovascular Medicine, Yale School of Medicine, and by our NIH T32 Training Grant in Implementation Science Research and Methods.

ID10109

To CiteDCA Citation Guide

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>