Trial Outcomes & Findings for Controlling Hypertension Outcomes by Improved Communication & Engagement (NCT NCT01134887)
NCT ID: NCT01134887
Last Updated: 2017-08-01
Results Overview
Veteran self-management of hypertension measured via the 13-item, (0-100 point range), Patient Activation Measure (PAM). Administered at baseline (1st visit) and after each additional follow-up visit during the next 12-months (+2 max). Rasch conversion changed raw scores to the PAM interval measure. Reported outcome is difference in mean PAM scores at baseline and during 12-month follow-up. If a participant had two PAM scores during the follow-up period, the average of the two was taken to calculate a combined follow-up score. Higher PAM scores represent higher levels of self-activation. Research on the PAM measure indicates that each point increase in PAM score correlates to a 2% decrease in hospitalization and a 2% increase in medication adherence. Ranges for Baseline PAM scores: Intervention = 46.1 (min) to 84.3 (max); Control = 43.2 (min) to 77 (max). Ranges for Follow-up PAM scores: Intervention = 48.4 (min) to 100 (max); Control = 45.1 (min) to 80.1 (max).
COMPLETED
NA
26 participants
12 months
2017-08-01
Participant Flow
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.
Participant milestones
| Measure |
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.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
9
|
11
|
5
|
5
|
|
Overall Study
COMPLETED
|
9
|
7
|
5
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
4
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Controlling Hypertension Outcomes by Improved Communication & Engagement
Baseline characteristics by cohort
| Measure |
Arm 1: Intervention-Veteran
n=9 Participants
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
n=11 Participants
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
n=5 Participants
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
n=5 Participants
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
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
21 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
23 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
9 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
30 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=5 Participants
|
11 participants
n=7 Participants
|
5 participants
n=5 Participants
|
5 participants
n=4 Participants
|
30 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Veterans participating in CHOICE study randomized to two arms: intervention or attention control. The 13-item Patient Activation Measure was administered at baseline and up to two additional times during the following 12 months. Rasch conversion of the raw PAM scores was performed to ensure the final scores were linear and interval measures.
Veteran self-management of hypertension measured via the 13-item, (0-100 point range), Patient Activation Measure (PAM). Administered at baseline (1st visit) and after each additional follow-up visit during the next 12-months (+2 max). Rasch conversion changed raw scores to the PAM interval measure. Reported outcome is difference in mean PAM scores at baseline and during 12-month follow-up. If a participant had two PAM scores during the follow-up period, the average of the two was taken to calculate a combined follow-up score. Higher PAM scores represent higher levels of self-activation. Research on the PAM measure indicates that each point increase in PAM score correlates to a 2% decrease in hospitalization and a 2% increase in medication adherence. Ranges for Baseline PAM scores: Intervention = 46.1 (min) to 84.3 (max); Control = 43.2 (min) to 77 (max). Ranges for Follow-up PAM scores: Intervention = 48.4 (min) to 100 (max); Control = 45.1 (min) to 80.1 (max).
Outcome measures
| Measure |
Arm 1: Intervention-Veterans
n=9 Participants
Veterans randomized to the intervention group 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. Additional information was provided on how to be an active participant in the health care encounter and how to communicate effectively to promote productive self-management. To facilitate communication change, the educator assisted the Veteran 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-Veterans
n=11 Participants
The attention control comparator consisted of giving Veterans 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.
|
|---|---|---|
|
Patient Activation Measure
Baseline PAM
|
61.33 units on a scale
Standard Deviation 13.39
|
60.86 units on a scale
Standard Deviation 11.41
|
|
Patient Activation Measure
Followup PAM
|
63.49 units on a scale
Standard Deviation 14.45
|
57.45 units on a scale
Standard Deviation 8.65
|
Adverse Events
Arm 1: Intervention
Arm 2: Attention Control
Arm 3: Intervention-Physicians
Arm 4: Control-Physicians
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Richard M. Frankel Ph.D.
Veterans Administration Health Services Research and Development
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place