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Controlling Hypertension Outcomes by Improved Communication & Engagement (CHOICE)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT01134887
First received: May 28, 2010
Last updated: March 15, 2016
Last verified: March 2016
Results First Received: February 3, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Health Services Research
Conditions: Hypertension
Stroke
Interventions: Behavioral: Video-Assisted Coaching
Other: Informational Guide for Patients
Other: Monograph for Physicians
Behavioral: Educational Coaching
Other: Control

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Ten physicians and 20 Veterans were recruited into the study at the Roudebush VA Medical Center in Indianapolis, Indiana. The 20 Veterans were patients in the panels of the ten participating physicians. Four patients did not complete the protocol reducing the overall number of completers to 26.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Arm 1: Intervention-Veteran Veterans enrolled in the "Intervention-Veterans" arm received a copy of the NIA guide for "Talking with Your Doctor." Just prior to their next scheduled visit an educator met with each Veteran in the intervention arm individually for 20-30 minutes to review the material in the pamphlet and develop a plan for enhancing communication about self-management of hypertension with their doctor. To facilitate communication change, the educator assisted the patient in setting a goal to achieve during their visit. The educator also provided telephone follow-up within 24 hours to review satisfaction and effectiveness of the visit and assess barriers and facilitators to communicating about self-management.
Arm 2: Control-Veteran Veterans enrolled in the "Control-Veterans" arm received a copy of the NIA guide for "Talking with Your Doctor.” This pamphlet was specifically developed for this purpose (updated in 2002). It has pictorials and is written at an 8th grade level.
Arm 3: Intervention-Physician Primary care providers randomly assigned to the "Intervention-Physicians" arm of this study received a copy of the Four Habits of Highly Effective Physicians. The Four Habits provided practical evidence-based advice for improving patient-physician communication. Second, physicians participated in an audiotaped intensive 30 minute, one-on-one educational intervention with PI Frankel after their first set of visits from their three participating patients, but before seeing them for follow-ups. The main goal of this meeting was to review and discuss the analysis of the physician's videotaped visits using the Four Habits framework, with a particular focus on improving communication about self-management.
Arm 4: Control-Physician Primary care providers randomly assigned to the "Control-Physicians" arm of the study did not receive coaching or additional resources, and conducted their primary care practice as usual.

Participant Flow:   Overall Study
    Arm 1: Intervention-Veteran     Arm 2: Control-Veteran     Arm 3: Intervention-Physician     Arm 4: Control-Physician  
STARTED     9     11     5     5  
COMPLETED     9     7 [1]   5     5  
NOT COMPLETED     0     4     0     0  
[1] Four patients in the Veteran-Control arm did not have two clinic visits videotaped and left study.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Arm 1: Intervention-Veteran Veterans enrolled in the "Intervention-Veterans" arm received a copy of the NIA guide for "Talking with Your Doctor." Just prior to their next scheduled visit an educator met with each Veteran in the intervention arm individually for 20-30 minutes to review the material in the pamphlet and develop a plan for enhancing communication about self-management of hypertension with their doctor. To facilitate communication change, the educator assisted the patient in setting a goal to achieve during their visit. The educator also provided telephone follow-up within 24 hours to review satisfaction and effectiveness of the visit and assess barriers and facilitators to communicating about self-management.
Arm 2: Control-Veteran Veterans enrolled in the "Control-Veterans" arm received a copy of the NIA guide for "Talking with Your Doctor.” This pamphlet was specifically developed for this purpose (updated in 2002). It has pictorials and is written at an 8th grade level.
Arm 3: Intervention-Physician Primary care providers randomly assigned to the "Intervention-Physicians" arm of this study received a copy of the Four Habits of Highly Effective Physicians. The Four Habits provided practical evidence-based advice for improving patient-physician communication. Second, physicians participated in an audiotaped intensive 30 minute, one-on-one educational intervention with PI Frankel after their first set of visits from their three participating patients, but before seeing them for follow-ups. The main goal of this meeting was to review and discuss the analysis of the physician's videotaped visits using the Four Habits framework, with a particular focus on improving communication about self-management.
Arm 4: Control-Physician Primary care providers randomly assigned to the "Control-Physicians" arm of the study did not receive coaching or additional resources, and conducted their primary care practice as usual.
Total Total of all reporting groups

Baseline Measures
    Arm 1: Intervention-Veteran     Arm 2: Control-Veteran     Arm 3: Intervention-Physician     Arm 4: Control-Physician     Total  
Number of Participants  
[units: participants]
  9     11     5     5     30  
Age  
[units: participants]
         
<=18 years     0     0     0     0     0  
Between 18 and 65 years     5     6     5     5     21  
>=65 years     4     5     0     0     9  
Gender  
[units: participants]
         
Female     0     0     3     4     7  
Male     9     11     2     1     23  
Ethnicity (NIH/OMB)  
[units: participants]
         
Hispanic or Latino     0     0     0     0     0  
Not Hispanic or Latino     0     0     0     0     0  
Unknown or Not Reported     9     11     5     5     30  
Region of Enrollment  
[units: participants]
         
United States     9     11     5     5     30  



  Outcome Measures

1.  Primary:   Patient Activation Measure   [ Time Frame: 12 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Richard M. Frankel Ph.D.
Organization: Veterans Administration Health Services Research and Development
phone: 317-988-4000
e-mail: Richard.Frankel@VA.Gov



Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01134887     History of Changes
Other Study ID Numbers: RRP 09-190
Study First Received: May 28, 2010
Results First Received: February 3, 2015
Last Updated: March 15, 2016
Health Authority: United States: Federal Government