Southeastern Collaboration to Improve Blood Pressure Control

Not Applicable

Completed

• Conditions: Hypertension
• Interventions: Behavioral: Practice Facilitation; Behavioral: Peer Coach; Behavioral: Enhanced usual care

• Registration Number: NCT02866669
• Lead Sponsor: University of Alabama at Birmingham

Brief Summary

The central objective of this proposal is to rigorously compare two strategies designed to improve BP control in primary care practices serving rural Southeastern African Americans with low socioeconomic status (SES) living in the "Black Belt".

In year 1, we're engaging community members (community members who have experience being community peer advisors or have high blood pressure) to develop the study interventions and protocols. In years 2-5, the investigators will test the interventions.

Year 2-5, Aim 3: Enroll 80 practices and 25 African American patients with uncontrolled HTN at each practice (total n=2000) in a cluster-randomized, controlled, 4-arm pragmatic implementation trial to evaluate the three multi- component, multi-level functional interventions finalized in the UH2 phase compared with enhanced usual care.

The study's 4 arms are:

1. Enhanced Usual Care: Practices are provided with educational materials and tools to enhance patient care

2. Peer Coaching: Patients enrolled in these practices will be matched with a peer coach. The peer coach helps the patient to set goals around self-management, including medications, home monitoring, and diet and exercise, and she helps the patient to strategize how to accomplish the goals, using motivational interviewing techniques

3. Practice Facilitation: Practices randomized to this arm will work with a practice facilitator. Practice facilitation is a highly customized, staged approach to helping a practice to implement process and structural changes to enhance the quality of care and improve patient and staff satisfaction

4. Peer coaching and practice facilitation: Practices randomized to this arm will receive both the peer coach intervention and the practice facilitation intervention. Practice facilitators and peer coaches will receive the same training for this hybrid intervention, but the practice facilitator change packet will add examples of activities that integrate peer coaches.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-06-13
• Study First Submitted QC: 2016-08-10
• Study First Posted: 2016-08-15
• Study Start: 2017-05-03
• Primary Completion: 2021-02-28
• Study Completion: 2021-02-28
• Results First Submitted: 2021-12-22
• Status Verified: 2023-10
• Results First Submitted QC: 2023-10-04
• Last Update Submitted: 2023-10-04
• Results First Posted: 2023-10-05
• Last Update Posted: 2023-10-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1592

Inclusion Criteria

• African American adults aged 19-85 years
• Uncontrolled HTN, defined as BP >140/90 mm Hg at the time of study enrollment
• Black Belt resident
• English speaking
• Willing to work with a peer coach
• Willing to sign informed consent

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Exclusion Criteria

• Plans to move out of the area within the next two years
• Advanced illness with limited life expectancy
• Pregnant or plans to get pregnant in the next year
• Advanced chronic kidney disease (estimated glomerular filtration rate <45 ml/min/1.73 m2)
• Unwillingness to work with a peer coach or to sign informed consent

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Peer coach and Practice facilitation	Peer Coach	Practices that are randomized to the practice facilitation arm will work with a practice facilitator that will help practice staff for 15 months to make practice level changes to improve hypertension control. The patients will also be matched with peer advisors who will work with the participants for 12 months.
Peer coach	Peer Coach	Participants enrolled from practices that are randomized to the peer coach arm will be matched with peer advisors who will work with the participants for 12 months.
Peer coach	Enhanced usual care	Participants enrolled from practices that are randomized to the peer coach arm will be matched with peer advisors who will work with the participants for 12 months.
Peer coach and Practice facilitation	Practice Facilitation	Practices that are randomized to the practice facilitation arm will work with a practice facilitator that will help practice staff for 15 months to make practice level changes to improve hypertension control. The patients will also be matched with peer advisors who will work with the participants for 12 months.
Practice facilitation	Practice Facilitation	Practices that are randomized to the practice facilitation arm will work with a practice facilitator that will help practice staff for 15 months to make practice level changes to improve hypertension control. Practice facilitation is a highly customized, staged approach to helping a practice to implement process and structural changes to enhance the quality of care and improve patient and staff satisfaction
Practice facilitation	Enhanced usual care	Practices that are randomized to the practice facilitation arm will work with a practice facilitator that will help practice staff for 15 months to make practice level changes to improve hypertension control. Practice facilitation is a highly customized, staged approach to helping a practice to implement process and structural changes to enhance the quality of care and improve patient and staff satisfaction
Peer coach and Practice facilitation	Enhanced usual care	Practices that are randomized to the practice facilitation arm will work with a practice facilitator that will help practice staff for 15 months to make practice level changes to improve hypertension control. The patients will also be matched with peer advisors who will work with the participants for 12 months.
Enhanced usual care	Enhanced usual care	Practices in the usual enhanced care arm will receive a blood pressure medication algorithm developed using national guidelines and content experts on our study team. Practices will be provided the Joint National Committee (JNC) recommended protocol to measuring blood pressures. Practices will receive a laptop workstation that has access to the Patient Activated Learning System - an online education video system.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Blood Pressure Control (Systolic Pressure Less Than 140 mm Hg and Diastolic Pressure Less Than 90 mm Hg) at 12 Months	12 months	Blood pressure (BP) control is defined as systolic pressure less than 140 mm Hg and diastolic pressure less than 90 mm Hg. Difference in BP control at 12 month follow-up between trial arms. BP was assessed in the practice by a research assistant using a standardized protocol at baseline, 6, and 12 months.

Secondary Outcome Measures

Name	Time	Method
Change in the Mental Component Summary Score (MCS) From the Short Form 12 (SF12)	12 months	Change in health related quality of life measured using self report scale Short form-12. Six questions comprise the MCS. Of the six questions, two questions are dichotomous as yes or no. One question ranges on a 5 point Likert scale from all of the time to none of the time. Three questions range on a 6 point Likert scale from all of the time to none of the time. Different weights are applied to each item to result in a score ranging from 0-100 with higher scores indicating higher mental functioning.
Self-reported ED Visit or Evidence of an ED Visit at Chart Review Between Baseline and 6 Months	between baseline and 6 months	Outcome was defined by self-reported question (yes/no) or chart review. Those who reported yes to the question, "In the past 6 months have you been seen in an ER/ED but not admitted overnight" were considered having the outcome. Data collectors looked for ED visits in patient's charts between baseline and 6 month visit. The outcome measure timeframe is between baseline and 6 months.
Change in Systolic Blood Pressure Between Baseline and 12 Months	12 months	Change in systolic blood pressure between baseline and 12 months, which is analyzed by subtracting the baseline systolic BP from the 12 month systolic BP.
Change in Physical Component Summary Score (PCS) of the Short Form 12 (SF12)	12 months	Change in health related quality of life measured using self report scale Short form-12. Six questions comprise the PCS. Of the six questions, one question ranges on a 5 point Likert scale from excellent to poor. Two questions range on a 3 point Likert scale from a lot to not at all. Two questions are dichotomous as yes or no. One question ranges on a 5 point Likert scale from extremely to not at all. Different weights are applied to each item to results in scores ranging from 0-100 with higher scores indicating higher functioning.
Self-reported Hospitalization or Evidence of Hospitalization in Chart Review Between Baseline and 6 Months	between baseline to 6 months	Outcome was defined by self-reported question (yes/no) or chart review. Those who reported yes to the question, "In the past 6 months have you been hospitalized overnight?" were considered having the outcome.; Data collectors looked for hospitalization in patient's charts between baseline and 6 month visit. The outcome measure timeframe is between baseline and 6 months.
Self-Reported Hospitalization or Evidence of Hospitalization in Chart Review Between 6 Month and 12 Month	between 6 month to 12 month	Outcome was defined by self-reported question (yes/no) or chart review. Those who reported yes to the question, "In the past 6 months have you been hospitalized overnight?" were considered having the outcome. Data collectors looked for hospitalizations in patient's charts between their 6 month and 12 month follow-up. The outcome measure timeframe is between 6 months and 12 month follow-up.
Change in Satisfaction With Chronic Illness Care Between Baseline and 12 Months	12 months	Patient Assessment of Care for Chronic Conditions (PACIC) measures how patients perceive their chronic condition(s) are being managed by their health care team. Patients fill out a survey of 20 questions regarding the care of their chronic condition(s) over the last 12 months. Used a Likert scale from 1-5, where 1 signifies "None of the time" and 5 signifying "Always". PACIC was scored by summing participants' responses across all 20 items then dividing by 20. This score was calculated at baseline and 12 months follow-up. A change in score for each participant was created by subtracting the 12 months follow-up PACIC score from the baseline PACIC score.
Self-reported ED Visit or Evidence of an ED Visit in Chart Review Between 6 Months and 12 Months	between 6 months to 12 month	Outcome was defined by self-reported question (yes/no) or chart review. Those who reported yes to the question, "In the past 6 months have you been seen in an ER/ED but not admitted overnight" were considered having the outcome. Data collectors looked for ED visits in patient's charts between their 6 month and 12 month follow-up. The outcome measure timeframe is between 6 months and 12 month follow-up.
Change in Perceived Stress	12 months	The 4-item Cohen perceived stress scale that are measured on a 5-point scale (0 = never, 1= almost never, 2 = sometimes, 3 = fairly often and 4- very often). Items 2 and 3 are reverse coded and then all for items are summed to created a total score that ranges from 0 -16. A higher score is negative indicating greater perceived stress.

Trial Locations

Locations (3)

University of Alabama At Birmingham; 🇺🇸 Birmingham, Alabama, United States

UNC Chapel Hill; 🇺🇸 Chapel Hill, North Carolina, United States

East Carolina University; 🇺🇸 Greenville, North Carolina, United States