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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00914485
Other study ID # IIR 07-194
Secondary ID
Status Completed
Phase N/A
First received June 3, 2009
Last updated April 6, 2015
Start date December 2009
Est. completion date March 2013

Study information

Verified date April 2015
Source VA Office of Research and Development
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

The proposed research will provide important insight into two serious problems for veterans' healthcare: 1) mixed effectiveness of communication improvement interventions in the VA to date, and 2) persistence of racial/ethnic disparities in VA healthcare.


Description:

The proposed research will provide important insight into two serious problems for veterans' healthcare: 1) mixed effectiveness of communication improvement interventions in the VA to date, and 2) persistence of racial/ethnic disparities in VA healthcare. We have identified 4 "best acts" of physician communication that patients believe to be most important in a clinical interaction. We propose to develop and evaluate a physician communication intervention that focuses specifically on these acts. In addition, our abundance of pilot study data from patients of various races/ethnicities enables us to create an intervention applicable to communication that spans patient race/ethnicity. Evaluating this intervention with physicians and patients in 2 independent VA primary care settings will help determine whether a patient-driven communication focus that incorporates input from patients of varied race/ethnicity can help "close the gap" in health outcomes between white and minority veterans.

We aim to (1) demonstrate the efficacy of using "best acts" of physician communication as content for an intervention to improve physician communication skills overall and reduce variation in communication with white versus racial/ethnic minority patients, and (2) assess the impact of patient experiences of "best acts" on patients' perceptual and behavioral outcomes.

We have collected data from over 200 primary care patients as they viewed a video of themselves and their physician interacting during a clinic visit. From these data, we are developing an educational intervention for physicians that focuses specifically on the 4 "best acts" we have identified. Scripts of the 4 "best acts" will be developed, and standardized patients at Baylor College of Medicine will perform the acts, which will be video recorded. We will then conduct a 2-site longitudinal observational study of 16 primary care physicians (8 at each site) and 36 patients of each physician. At the first site at 3-month intervals, physicians will attend an instruction session consisting of viewing a video of one best act and participating in group discussion, role-playing re-enactment of the act, and formulation of bulleted "take-away" points to facilitate subsequent recall. Once completed, the sequence of sessions will occur at the second site. At both sites, clinical interactions of participating physicians and patients will be audio recorded, and audio recordings will be analyzed for frequency of occurrence of the 4 "best acts." After each study visit, each patient will complete validated surveys measuring patients' perceptions of their physician on 4 affective dimensions known to impact patients' subsequent perceptual and behavioral outcomes. Efficacy will be assessed across patient demographics.


Recruitment information / eligibility

Status Completed
Enrollment 369
Est. completion date March 2013
Est. primary completion date February 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

Any patient included in the regular panel of a participating physician at either study site who is a returning patient for that physician. Since 2 of the patient perceptual measures included require the pre-existence of a relationship with a specific physician, we will only enroll patients who have been seen by their physician before.

Exclusion Criteria:

- Physical disabilities that prohibit unassisted participation in research protocol:

- legal blindness

- dementia

- severe post-traumatic stress disorder

- schizophrenic disorder

- Alzheimer's disease

- bipolar disorder

- and severe anxiety and/or mood disorders (must be documented in patient's medical record or attested to by patient, physician or charge nurse).

- Also, no patients new to VA primary care or to a given participating physician will be enrolled.

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research


Related Conditions & MeSH terms


Intervention

Behavioral:
Provider Communication Skills Training
Consists of 4 separate 1-hour sessions, 1 per "best act," in which physicians view 3 video-recorded performances of each act performed by trained actors of varied race/ethnicity.

Locations

Country Name City State
United States Michael E. DeBakey VA Medical Center, Houston, TX Houston Texas
United States Southeast Louisiana Veterans Health Care System, New Orleans, LA New Orleans Louisiana

Sponsors (1)

Lead Sponsor Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Provider Use of Best Acts From Baseline to Post-Intervention Mean per-patient use of "best acts" learned during provider communication skills intervention, post-intervention minus baseline. Baseline, 18 months No
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