Community Health Workers Using Patient Stories to Support Hypertension Management

Study Overview
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Brief Summary
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Community Health Workers (CHWs) using patient stories to support hypertension management is a randomized controlled trial to evaluate the implementation of a CHW-delivered culturally appropriate storytelling intervention for english and spanish-speaking patients diagnosed with hypertension who receive care at community health center settings.

Detailed Description
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Community Health Workers (CHWs) using patient stories to support hypertension (HTN) management is a CHW-delivered culturally appropriate storytelling intervention for patients diagnosed with HTN. We will develop and test interactive videos presenting stories of patients who have successfully made changes enhancing blood pressure control; and integrate this new tool with a CHW approach to management of hypertension. This two site, two-armed randomized controlled trial aims to recruit 252 english and spanish speaking patients with uncontrolled HTN. All participants are randomized to receive five visits (two in-person and 3 telephone calls) with CHWs either immediately (intervention condition (I)) or 6 months after enrollment (delayed intervention (DI)). Intervention participants receive the intervention immediately and DI participants receive print materials at enrollment and are telephoned 4-6 months after enrollment to schedule an in-person visit at the health enter to begin receiving the intervention protocol.

Official Title
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Community Health Workers Using Patient Stories to Support Hypertension

Conditions
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Hypertension

Intervention / Treatment
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* Behavioral: Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: English and Spanish speaking patients Male or female between the ages of 30 and 80 Diagnosis of HTN and uncontrolled HTN, defined as (a) having an average systolic BP greater than or equal to 140 and /or diastolic BP greater than or equal to 90 over the past 12 months or (b) most recent BP reading within the previous 6 months as systolic BP greater than or equal to 140 and /or diastolic BP greater than or equal to 90. Willingness to be randomized to either intervention or delayed intervention Exclusion Criteria: Pregnant women Patients planning to leave the Community Health Center in the next year Adults unable to consent

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Patients will receive five visits with a CHW during a 6 month period (two in-person and three by telephone). At the first visit, patients will meet the CHW who is trained in motivational interviewing techniques to deliver coaching to work on behavioral changes and introduce a 60 minute Digital Video Disc of five patient stories of individuals who have managed to control their hypertension. | Behavioral: Intervention<br>* During an in-person visit, patients receive a pamphlet in english and spanish and a storytelling Digital Versatile Disc (DVD) (developed for this project from interviews with hypertensive patients), supplemented by motivational interviewing delivered by the CHW. The CHW explores the patient's motivation to change associated with hypertension and counsels on risk factor control (tobacco, diet, physical activity). Patients receive a followup telephone call from the CHW in 2 weeks, 4 weeks, 2 months to support any changes or goals discussed at first visit. Six months after first intervention visit, patients are invited to schedule an in-person visit with the CHW at the health center to discuss goals and provide support for change.<br>|
| Other: Delayed Intervention<br>Patients will receive print materials at time of consent and randomization. Four to six months after randomization, DI patients will receive an invitation to schedule an in-person visit at the health center to begin receiving the intervention protocol. | Behavioral: Intervention<br>* During an in-person visit, patients receive a pamphlet in english and spanish and a storytelling Digital Versatile Disc (DVD) (developed for this project from interviews with hypertensive patients), supplemented by motivational interviewing delivered by the CHW. The CHW explores the patient's motivation to change associated with hypertension and counsels on risk factor control (tobacco, diet, physical activity). Patients receive a followup telephone call from the CHW in 2 weeks, 4 weeks, 2 months to support any changes or goals discussed at first visit. Six months after first intervention visit, patients are invited to schedule an in-person visit with the CHW at the health center to discuss goals and provide support for change.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes in systolic and diastolic BP (SBP and DBP) | Entering SBP and DBP will be the most recent BP values in the 6 months before entry; exit BP values will be the average of two BP values taken at study exit. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduce sodium intake | Self report of behavior change | 6 months | 
| Increased physical activity | Self report of behavior change | 6 months | 
| Greater medication adherence | Self report of behavior change | 6 months | 
| Blood Pressure maintenance | SBP and DBP will be the value obtained from the Electronic Health Record visit date 12 months after enrollment | 12 months |