BP-HOME MONITOR Blood Pressure-HOME MONitoring Intervention Trial and Outcomes Research

Transcription

1 BP-HOME MONITOR Blood Pressure-HOME MONitoring Intervention Trial and Outcomes Research IMPLEMENTATION SCIENCE GROUP Ambuj Roy Anastase Dzudie Cheryl Anderson Deepak Kamath Namratha Kandula Rafael Vidal Perez Renato Quispe Sheikh Mohammed Shariful Islam Syed Shah

2 Time has passed First Project was presented during WHFEL meeting in Lima in 2015 Seed grant by WHF was given More people joined the Project and our Project is evolving Jaime Miranda Mentor of the project Ambuj Roy (India) Anastase Dzudie (Cameroon) Cheryl Anderson (USA) Deepak Kamath (India) Maria Amalia Pesantes (Peru) Namratha Kandula (USA) Rafael Vidal Perez (Spain) Sufia Dhadabhai (Malawi) Renato Quispe (Peru) Albertino Damasceno (Mozambique) Sheikh Mohammed Shariful Islam (Bangladesh) Syed Shah (UAE Pakistan)

3 How to develop the project Online communication & Teleconference schedule

4 Objective of the project The overall objective of this project is to examine whether an intervention of home blood pressure management is feasible in lowand middle-income countries. Home blood pressure management is defined as self-monitoring of blood pressure and selftitration of anti-hypertensive medications

5 Rationale of the study 1) Documentation that control of hypertension in low- and middle-income countries is poor, often <10% 2) Strong body of evidence that home blood pressure management lowers blood pressure 3) Recent guidelines from the National Institute of Clinical Health and Excellence (NICE) that recommends home blood pressure monitoring 4) The observation that the preponderance of data on the benefits of home blood pressure management comes from studies in high-income countries.

6 Significance and Impact In high income countries, home blood pressure management lowers blood pressure (BP) when compared to usual care. There is scarce data available about home BP management in low- and middle-income countries. Given the great burden of hypertension in lowand middle-income countries, identification of effective strategies to optimize BP management is critical. Lancet 2010; 376: JAMA 2014;312(8):

7 SUMMARY OF PREVIOUS STUDIES Population Intervention Control Outcomes TASMINH2 Uncontrolled hypertension [BP>140/90 mmhg) Aged without establish vascular disease Patient self monitoring + drug titration Usual care Mean SBP Differences between groups mmhg, 2.4 to 8.5; p=.0004 At 12 months TASMIN-SR Uncontrolled hypertension [BP>145/90 mmhg) Aged> 35 with high risk (CVD or DM) Patient self monitoring + drug titration Usual care Mean SBP Differences between groups mmhg, 5.7 to At 12 month Lancet 2010; 376: JAMA 2014;312(8):

8 Research Question Can an intervention focused on patient home BP management (i.e., monitoring and medication titration) be implemented in low- or middleincome countries?

9 Conceptual Framework

10 Specific Aims Specific Aim #1: To assess the barriers, facilitators and context for home blood pressure (BP) management in lowand middle-income countries. Hypothesis: There will be unique contextual factors that will inform the design of a clinical trial of home blood pressure management in low- and middle-income countries.

11 Specific Aims Specific Aim #2: To conduct a process evaluation to explore intervention feasibility and acceptability. Specific Aim #3: To beta test home blood monitors and titration protocols and materials. pressure

12

13 METHODS FOR AIM 1 To conduct a qualitative study of barriers, facilitators and context for home BP management in low- and middle-income countries. Study population for Aim 1 +We will obtain information from patients, family caregivers, and health care providers. +The goal is to understand the barriers and facilitators of self-monitoring blood pressure and medication self-titration in LMIC. We will recruit patients, family caregivers, and stakeholders at each of the 7 sites: 1) Gilgit, Pakistan 2) Blantyre, Malawi 3) Bangalore, India, 4) Dhaka, Bangladesh, 5) Lima, Peru 6) Douala, Cameroon 7) Mozambique

14 METHODS FOR AIM 1 To conduct a qualitative study of barriers, facilitators and context for home BP management in low- and middle-income countries. Study population for Aim 1 +Sampling will be purposive and heterogeneous to capture individuals with family caregivers and those without, and those with longer-standing hypertension ( 3years) and those with a newer diagnosis (< 3years). +We will exclude participants with resistant hypertension. +Study participants will be selected through outpatient medical clinics in each city. Patients from the practices that fall under the inclusion criteria will be invited to participate in the study. +Key informants (i.e., health care providers) from the health care teams and health care systems will be invited through local contacts

15 METHODS FOR AIM 1 To conduct a qualitative study of barriers, facilitators and context for home BP management in low- and middle-income countries. Description of procedures for Aim 1 +Perspectives of patients, family caregivers, and health care workers will be obtained using two qualitative research techniques: -focus group discussions (patients and family caregiver), -in depth semi-structured interviews (health workers). At least two focus groups of patients with their family caregivers will be formed in each city, and there will be 6 to 9 participants in each group. +The focus group discussion guide was developed collaboratively using literature review, and expert and local team input (See Appendix A for Focus Group Discussion Guide )

16

17 METHODS FOR AIM 1 To conduct a qualitative study of barriers, facilitators and context for home BP management in low- and middle-income countries. Description of procedures for Aim 1 +Key informant interviews will use a semi-structured interview guide developed with the same process. Key informants from the health care systems will include primary care physicians and cardiologists, nurses, and community health workers. +Data collection and data analysis guides and protocols will be standardized across sites to ensure cross-national comparisons of qualitative data, and they will be adapted so that they are culturally and contextually appropriate. We will also use standardized checklists and interviews to obtain information from study participants, and data collection will be conducted by individuals trained in qualitative research methods

18 METHODS FOR AIM 2: To conduct a process evaluation to explore intervention feasibility and acceptability. Study population for Aim 2 +We will recruit 8-10 health care providers at each of the 7 study sites. +The goal is to understand the feasibility and acceptability of self-monitoring blood pressure and medication self-titration from the perspective of health care providers in LMIC. +We will recruit a purposive sample of participants with a goal of obtaining equal numbers of men and women. We will also consider age group, type of provider (e.g., physician, nurse, community health worker), specialty, and location of their practice (ensure that this is complementary with where intervention trial activities may occur at a later date).

19 METHODS FOR AIM 2: To conduct a process evaluation to explore intervention feasibility and acceptability. Description of procedures for Aim 2 +A semi-structured interview will be conducted with health care providers at each site (See Appendix B for Interview Guide for Health Care Providers ) +The interview will cover the following topics: overall experience and attitude about high blood pressure; whether patients are currently asked to measure and monitor their own blood pressure; what are possible barriers to treatment and adherence to blood pressure management strategies; role of the health care provider in helping patients with high blood pressure management; whether they would be interested in participating in an intervention about self-management of blood pressure; and general thoughts about strategies to improve the lives of patients and the treatment of high blood pressure. +We will also obtain feedback from providers about the approach that would be used by the patient for self-titration of medication. We are interested in knowing about the following topics: the appropriateness of the frequency of medication titration, clarity and readability of instructions, and comfort level of health care team with the actions recommended; and what can be done to improve successful use of the self-titration protocol by patients.

20

21 METHODS FOR AIM 3: To beta test home blood pressure monitors and titration protocols and materials. Study population for Aim 3. +We will choose 5 patients (some of them will have a family caregiver) at the trial site who meet study inclusion criteria. We will seek the assistance of clinic staff in identifying patients and their caregivers. +The patients will be asked to use the blood pressure monitors and diaries, and provide feedback (see Appendix C for Patient Interview about BP Monitors and Titration Protocols ). +We will also recruit providers who would likely participate in our future intervention study about self-management of blood pressure. This will include 10 physicians, nurses, and community health workers. They will be asked to review the study s medication titration protocol and provide feedback (see Appendix D for Provider Interview about Titration Protocol ).

22

23

24 METHODS FOR AIM 3: To beta test home blood pressure monitors and titration protocols and materials.. Description of procedures for patients regarding Aim 3 The procedures to beta test the home blood pressure management approaches involves four steps. 1 st ) Patients and caregivers will be trained by study personnel and instructed to use the blood pressure monitor and to record readings in a diary. The patient will perform a blood pressure measurement in front of study staff. The study staff will use predetermined criteria to assess adequacy of training (see Appendix E for Patient Blood Pressure Diary and Checklist ). 2 nd ) Study personnel will provide patients with a blood pressure monitor and diary to use at home. Consistent with the protocol for the recently completed highly successful TASMIN trial, patients will be asked to measure their blood pressure two times over one week: once in the morning and once in the evening. They will be required to take two readings 5 minutes apart at each time point and record the values in the study diary.

25

26 METHODS FOR AIM 3: To beta test home blood pressure monitors and titration protocols and materials.. Description of procedures for patients regarding Aim 3 The procedures to beta test the home blood pressure management approaches involves four steps. 3 rd ) At the end of the week, patients will be asked to return to the clinic for: 1) an interview about their experience and how it could be made better; and 2) to complete an interviewer-administered usability scale (see Appendix F for Usability Scale and Checklist ). The interviewer will ask patients for feedback on the diverse topics and about process variables 4 th ) While patients are at the clinic, we will also show them a hypothetical medication up-titration protocol, based on their current hypertension medication regimen. This hypothetical protocol will have been designed and approved by a study physician in consultation with the treating physician. Patients will be asked for feedback on barriers and facilitators that may affect fidelity to the hypothetical protocol. We are specifically interested in the clarity and readability of instructions, and comfort level of patient/family caregiver with the actions recommended.

27

28

29 DATA MANAGEMENT AND ANALYSIS FOR AIMS 1, 2, AND 3 +We have guidelines for the number of participants that will be recruited at each site for study. However, the final sample size for interviews and focus group discussions will be determined based on the principle of saturation. +Once the interviews and group discussions begin, the researchers will determine, based on the information obtained, whether involving another participant or group adds important new data.. +All interviews and group discussions will be digitally recorded upon receiving the consent of participants. Recorded interviews and focus group discussions will be reviewed by the local researcher in order to extract the relevant data for analysis. Using the coding on the spot method each researcher will record the data in the original language in a common template (see Appendix G for Data Extraction Matrix ).

30

31 DATA MANAGEMENT AND ANALYSIS FOR AIMS 1, 2, AND 3 +After completing each recording, the researcher will verify the information entered in the matrix to ensure it is clear and non-redundant. It is also possible that a new topic emerges from the data extraction process and it is possible for this new topic to be added. +Relevant data is that which provides information around the core seven research topics: 1) Blood pressure management and measurement 2) Medication adherence and Medication titration: barriers and facilitators 3) Patient-physician relationship 4) Characteristics of local health care system 5) Perceptions about Home BP Monitoring 6) Understanding of blood pressure measurements 7) Social Support.

32 DATA MANAGEMENT AND ANALYSIS FOR AIMS 1, 2, AND 3 +Interim analysis will occur alongside the data collection. After each data collection round (interview or focus group discussion), the data will be reviewed by the researchers to further refine the data collection processes. The full process of analyzing across different languages will be documented. +Coding and categorization will be carried out by at least two team members trained in qualitative methods. Reports of the analysis will be produced for each site for review of local team members. The analysis will use both inductive codes and a priori categories. +Final collation of the analyses using the English translations will be centralized for the final analysis. All data from beta-testing of the home blood pressure monitors and titration protocols will be used to in an iterative process to adapt and improve blood pressure monitoring and titration materials and protocols.

33 HUMAN SUBJECTS To ensure the protection of human subjects, we will obtain ethical clearance at all participating sites. IRB applications will be submitted prior to beginning all work. INFORMED CONSENT Written informed consent will be obtained from study participants prior to any study activities involving data collection (See Appendix H for Informed Consent ). DATA MANAGEMENT, QUALITY ASSURANCE, QUALITY CONTROL Standard data management, quality assurance and quality control will be followed.

34

35 BUDGET

36 TIMELINE

37

38 Expected Outcomes -In our first step of the study we expect to find unique contextual factors that will inform the design of a clinical trial of home blood pressure management in low- and middle-income countries. -In further steps our expected outcomes are to create strategies for the improvement in the blood pressure control and medication adherence that could help us to reduce cardiovascular events

39 Expected impact on global heart health -The potential impact of this work is high because of the high global burden of hypertension in low- and middle- income countries; thereby, identification of innovative and effective strategies to control blood pressure is critical. -To the best of our knowledge, our study aims to be one of the first to provide evidence of the feasibility and utility of home blood pressure management to optimize blood pressure management in these settings. -We hypothesize that self management will optimize management of blood pressure in a low income setting by reducing delays in medication titration and improving adherence to antihypertensive medication.

40 Progress to date -The team is presenting the protocol to respective IRBs and will begin with the research for the first objective after approval has been received -The team is also submitting the project for some grants to help us to reach our objectives.- + MRC + NIH + CFAR (Center for Aids Research) -The team is preparing a manuscript about the protocol and about the qualitative research in this area

41 @rafavidalperez