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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
1,592
ractices 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
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.
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.
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
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
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.
Time frame: 12 months
Change in Systolic Blood Pressure Between Baseline and 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.
Time frame: 12 months
Change in Satisfaction With Chronic Illness Care Between Baseline and 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.
Time frame: 12 months
Change in Physical Component Summary Score (PCS) of the Short Form 12 (SF12)
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.
Time frame: 12 months
Change in the Mental Component Summary Score (MCS) From the Short Form 12 (SF12)
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.
Time frame: 12 months
Self-reported ED Visit or Evidence of an ED Visit at Chart Review 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.
Time frame: between baseline and 6 months
Self-reported ED Visit or Evidence of an ED Visit in Chart Review Between 6 Months and 12 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 their 6 month and 12 month follow-up. The outcome measure timeframe is between 6 months and 12 month follow-up.
Time frame: between 6 months to 12 month
Self-reported Hospitalization or Evidence of Hospitalization in Chart Review 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 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.
Time frame: between baseline to 6 months
Self-Reported Hospitalization or Evidence of Hospitalization in Chart Review Between 6 Month and 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.
Time frame: between 6 month to 12 month
Change in Perceived Stress
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.
Time frame: 12 months
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