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Controlling Hypertension Outcomes by Improved Communication & Engagement (CHOICE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01134887
First received: May 28, 2010
Last updated: April 18, 2013
Last verified: February 2012
History of Changes
  Purpose

This proposed randomized control study will test the feasibility of two communication enhancement interventions: one with veterans who have had a stroke and now demonstrate poorly controlled hypertension; the other with VA primary care providers who provide routine outpatient medical care to these veterans. This study will intervene 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.


Condition Intervention
Hypertension
Stroke
 Behavioral: Four Habits Model

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Controlling Hypertension Outcomes by Improved Communication & Engagement (CHOICE)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • self-management of hypertension [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: August 2010
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1

A health educator will meet 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 will provide the Four Habits communication training to the 5 primary care providers in the intervention arm. Two clinic visits between each participating provider-patient pair will be videotaped and coded.

 Behavioral: Four Habits Model
The providers randomized to the intervention arm will be trained in Habit 1 of the Four Habits Model.
No Intervention: Arm 2
Two clinic visits between each participating provider-patient pair will be videotaped and coded.

Detailed Description:

The communication intervention has 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 will meet 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 will provide the Four Habits communication training to the 5 primary care providers in the intervention arm. Two clinic visits between each participating provider-patient pair will be videotaped and coded.

This proposed project will enroll 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 have had a stroke and now demonstrate poorly controlled hypertension. The evaluation will determine if there is a difference, as well as compare the content of the provider-patient conversations around hypertension management, between the two groups. It will also involve a business case analysis to evaluate return on investment to the VHA.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01134887

Locations
United States, Indiana
Richard Roudebush VA Medical Center
Indianapolis, Indiana, United States, 46202-2884
Richard Roudebush VA Medical Center, Indianapolis
Indianapolis, Indiana, United States, 46202-2884
Sponsors and Collaborators
Department of Veterans Affairs
Investigators
Principal Investigator: Richard M. Frankel, PhD Richard Roudebush VA Medical Center
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT01134887     History of Changes
Other Study ID Numbers: RRP 09-190
Study First Received: May 28, 2010
Last Updated: April 18, 2013
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
hypertension
physician-patient relations
communication

Additional relevant MeSH terms:
Hypertension
Stroke
Vascular Diseases
Cardiovascular Diseases
 Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on May 19, 2013