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 16, 2014
Last verified: April 2014

May 28, 2010
April 16, 2014
August 2010
September 2011   (final data collection date for primary outcome measure)
self-management of hypertension [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01134887 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Controlling Hypertension Outcomes by Improved Communication & Engagement
Controlling Hypertension Outcomes by Improved Communication & Engagement (CHOICE)

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
  • Hypertension
  • Stroke
Behavioral: Four Habits Model
The providers randomized to the intervention arm will be trained in Habit 1 of the Four Habits Model.
  • 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.

    Intervention: Behavioral: Four Habits Model
  • No Intervention: Arm 2
    Two clinic visits between each participating provider-patient pair will be videotaped and coded.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
September 2011
September 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01134887
RRP 09-190
No
Department of Veterans Affairs
Department of Veterans Affairs
Not Provided
Principal Investigator: Richard M. Frankel, PhD Richard Roudebush VA Medical Center
Department of Veterans Affairs
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP