Controlling Hypertension Outcomes by Improved Communication & Engagement

Stroke Clinical Trial

— CHOICE  

Official title:

Controlling Hypertension Outcomes by Improved Communication & Engagement (CHOICE)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01134887
• Other study ID #: RRP 09-190
• Status: Completed
• Phase: N/A
• First received: May 28, 2010
• Last updated: November 14, 2014
• Start date: August 2010
• Est. completion date: September 2011

Study information

• Verified date: November 2014
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

This randomized control study tested the feasibility of two communication enhancement interventions: one with veterans who had a stroke and demonstrated poorly controlled hypertension; the other with VA primary care providers who provided routine outpatient medical care to these veterans. This study intervened with both members of the provider-patient dyad in an attempt to improve the self-management of hypertension by improving communication during visits to the VA outpatient clinic, specifically by enabling veterans to communicate their questions and concerns about chronic disease self-management to their providers more effectively, and to help providers improve their ability to communicate more effectively with this population of veterans.

Description:

The communication intervention had two goals; (a) coaching to enhance veteran's abilities to communicate their questions and concerns about self-management for hypertension to their physician; and (b) improving provider's communication skills for enhancing and encouraging self-management of hypertension.

A health educator met with each participating veteran in the intervention arm prior to the 2nd visit to develop a plan for enhancing communication about self-management of hypertension.

The PI provided the Four Habits communication training to the 5 primary care providers in the intervention arm. Two clinic visits between each participating provider-patient pair were videotaped and coded.

This proposed project enrolled 10 VA primary care providers to participate in the randomized control trial and 30 veterans (3 veterans from the panel of each of the 10 participating providers) who had a stroke and now demonstrated poorly controlled hypertension. The study evaluated the difference between the two groups, and compared the content of the provider-patient conversations around hypertension management.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Veteran:

• Veteran is a patient of the enrolled provider

• History of prior stroke

• Poorly controlled hypertension with at least one measurement >140/90 mm Hg in the past 12 months

• Complete a 6-item screen for cognitive and language impairment with a score of 3 or higher

• Sign the VA Media consent for use of picture and/or voice

Provider:

• Primary care provider, Medicine Service

• Sign VA media consent for use of picture and/or voice

Exclusion Criteria:

• Life expectancy is less than 6 months

• Non-English language patients

• Inability to provide informed consent

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Hypertension
• Stroke

Intervention

Behavioral:
• Four Habits Model
The providers randomized to the intervention arm received training in Habit 1 of the Four Habits Model.

Locations

Country	Name	City	State
United States	Richard Roudebush VA Medical Center	Indianapolis	Indiana
United States	Richard Roudebush VA Medical Center, Indianapolis	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	self-management of hypertension		12 months	No