Hypertension, Stroke
Conditions
Keywords
hypertension, physician-patient relations, communication
Brief 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.
Detailed 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 project had a goal of enrolling 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.
Interventions
OTHERInformational Guide for Patients
Veterans 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.
BEHAVIORALVideo-Assisted Coaching
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 video-assisted coaching session 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.
OTHERMonograph for Physicians
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.
BEHAVIORALEducational Coaching
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 \[Coaching\]. 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.
OTHERControl
The primary care providers randomly assigned to the Control-Physicians arm did not receive any additional coaching or resources and conducted their practice as usual.
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Activation Measure | 12 months | 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). |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 9 |
| 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. | 11 |
| 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. | 5 |
| 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. | 5 |
| Total | 30 |
Baseline characteristics
| Characteristic | Arm 2: Control-Veteran | Arm 3: Intervention-Physician | Arm 4: Control-Physician | Total | Arm 1: Intervention-Veteran |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 5 Participants | 0 Participants | 0 Participants | 9 Participants | 4 Participants |
| Age, Categorical Between 18 and 65 years | 6 Participants | 5 Participants | 5 Participants | 21 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 11 Participants | 5 Participants | 5 Participants | 30 Participants | 9 Participants |
| Region of Enrollment United States | 11 participants | 5 participants | 5 participants | 30 participants | 9 participants |
| Sex: Female, Male Female | 0 Participants | 3 Participants | 4 Participants | 7 Participants | 0 Participants |
| Sex: Female, Male Male | 11 Participants | 2 Participants | 1 Participants | 23 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 9 | 0 / 11 | 0 / 5 | 0 / 5 |
| serious Total, serious adverse events | 0 / 9 | 0 / 11 | 0 / 5 | 0 / 5 |
Outcome results
Primary
Patient Activation Measure
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).
Time frame: 12 months
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 1: Intervention-Veterans | Patient Activation Measure | Baseline PAM | 61.33 units on a scale | Standard Deviation 13.39 |
| Arm 1: Intervention-Veterans | Patient Activation Measure | Followup PAM | 63.49 units on a scale | Standard Deviation 14.45 |
| Arm 2: Control-Veterans | Patient Activation Measure | Baseline PAM | 60.86 units on a scale | Standard Deviation 11.41 |
| Arm 2: Control-Veterans | Patient Activation Measure | Followup PAM | 57.45 units on a scale | Standard Deviation 8.65 |