Community Health Workers Using Patient Stories to Support Hypertension Management

Community Health Workers Using Patient Stories to Support Hypertension

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.

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Behavioral: Intervention

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 171
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Lowell, Massachusetts, United States, 01852
      • Lowell Community Health Center
    • Worcester, Massachusetts, United States, 01655
      • Family Health Center of Worcester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; 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; 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.
Other: Delayed Intervention; 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; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Massachusetts, Worcester
• Investigators: Principal Investigator: Warren Ferguson, M.D., University of Massachusetts, Worcester

Publications and helpful links

General Publications

• Houston TK, Allison JJ, Sussman M, Horn W, Holt CL, Trobaugh J, Salas M, Pisu M, Cuffee YL, Larkin D, Person SD, Barton B, Kiefe CI, Hullett S. Culturally appropriate storytelling to improve blood pressure: a randomized trial. Ann Intern Med. 2011 Jan 18;154(2):77-84. doi: 10.7326/0003-4819-154-2-201101180-00004. Erratum In: Ann Intern Med. 2011 May 17;154(10):708.
• Ostchega Y, Dillon CF, Hughes JP, Carroll M, Yoon S. Trends in hypertension prevalence, awareness, treatment, and control in older U.S. adults: data from the National Health and Nutrition Examination Survey 1988 to 2004. J Am Geriatr Soc. 2007 Jul;55(7):1056-65. doi: 10.1111/j.1532-5415.2007.01215.x.
• Egan BM, Zhao Y, Axon RN. US trends in prevalence, awareness, treatment, and control of hypertension, 1988-2008. JAMA. 2010 May 26;303(20):2043-50. doi: 10.1001/jama.2010.650.
• McWilliams JM, Meara E, Zaslavsky AM, Ayanian JZ. Differences in control of cardiovascular disease and diabetes by race, ethnicity, and education: U.S. trends from 1999 to 2006 and effects of medicare coverage. Ann Intern Med. 2009 Apr 21;150(8):505-15. doi: 10.7326/0003-4819-150-8-200904210-00005.
• Swider SM. Outcome effectiveness of community health workers: an integrative literature review. Public Health Nurs. 2002 Jan-Feb;19(1):11-20. doi: 10.1046/j.1525-1446.2002.19003.x.
• Hargraves JL, Bonollo D, Person SD, Ferguson WJ. A randomized controlled trial of community health workers using patient stories to support hypertension management: Study protocol. Contemp Clin Trials. 2018 Jun;69:76-82. doi: 10.1016/j.cct.2018.04.004. Epub 2018 Apr 12.

Study record dates

Study Major Dates

• Study Start (Actual): April 14, 2014
• Primary Completion (Actual): September 14, 2016
• Study Completion (Actual): December 29, 2016

Study Registration Dates

• First Submitted: August 17, 2016
• First Submitted That Met QC Criteria: August 17, 2016
• First Posted (Estimate): August 22, 2016

Study Record Updates

• Last Update Posted (Actual): October 25, 2017
• Last Update Submitted That Met QC Criteria: October 23, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: 5P60MD006912-02 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO