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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00057083
Other study ID # TEL 20-036
Secondary ID
Status Completed
Phase N/A
First received March 27, 2003
Last updated April 6, 2015
Start date March 2003
Est. completion date October 2007

Study information

Verified date February 2008
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 purpose of this study is to determine whether the physical separation between patient and physician required during telemedicine has an affect on physician-patient communication and related outcomes, including patient and physician satisfaction, patient compliance, and patient understanding of medical care.


Description:

BACKGROUND/RATIONALE:

The Veterans Administration system supports telemedicine (TM) to provide medical consultations between patients and physicians via videoconference. At present, little is known about the impact of such TM consultations on patient-physician communication and related health outcomes. Analyses of in-person (IP) medical encounters have shown that effective patient-physician communication is associated with improved health outcomes.

OBJECTIVE(S):

To determine whether the physical separation between patient and physician required during TM has an affect on patient-physician communication and related outcomes, including patient and physician satisfaction, patient compliance, and patient understanding of medical care.

METHODS:

In this clinical trial, 238 patients were randomized to receive either consultative care at the remote site via TM with a consultant physician located the Milwaukee VA (intervention) OR by an IP consultation with a consultant physician at the Milwaukee VA (control). The same group of consultant physicians provided both IP and TM consultations.

Patients in both study arms had their medical encounter video recorded. We compared patterns and quality of patient-physician communication for the TM and IP encounters, using the Roter Interaction Analysis System. Data on patient and physician satisfaction with the encounter and patients' understanding of their medical problems were collected at the end of each medical encounter. Patient compliance (medication refill behavior) was assessed at 90 days post visit. The frequency of communication behaviors during the TM and IP encounters was compared using the analysis of a Linear Mixed Model. Comparison of patient satisfaction, physician satisfaction, patient compliance, and patient knowledge measures between TM and IP groups were conducted with similar Linear Mixed Models.


Recruitment information / eligibility

Status Completed
Enrollment 221
Est. completion date October 2007
Est. primary completion date October 2007
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

Only adult (age>18) patients referred from the Appleton Clinic are eligible. All Appleton patients who are considered new patient referrals (ie, have never been seen in the pulmonary, rheumatology, and endocrine clinics at the Milwaukee VA) will be eligible. Appleton patients who have previously been seen by any of the nine participating endocrine, pulmonary, and rheumatology physicians at the Milwaukee VA will be eligible. These follow-up patients will be scheduled with the previously seen participating physician, so there is no disruption of the ongoing patient-provider relationship. Patients that have established care with a non-participating provider will not be eligible. Patients that have been referred to the specialist for an outpatient procedure (eg, request to perform pulmonary function testing or bronchoscopy) will not be eligible. Repeat visits to the same or any other participating physician will not be eligible. Adult patients who have a significant communication disability (severe speech and hearing impairment, severe dementia, or mental health condition resulting in a non-communicative patient) and are considered mentally competent to provide informed written consent will not be eligible. Patients with disabilities other than those mentioned will be eligible.

Exclusion Criteria:

Patients that have established care with a non-participating provider will not be eligible to participate. Patients that have been referred to the specialist for an outpatient procedure (e.g. request to perform pulmonary function testing or bronchoscopy) will not be eligible. Repeat visits to the same or any other participating physician will not be eligible. Adult patients who have a significant communication disability (severe speech and hearing impairment, severe dementia, or mental health condition resulting in a non-communicative patient) and are considered mentally competent to provide informed written consent will not be eligible to participate.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Other:
Telemedicine Care


Locations

Country Name City State
United States VA San Diego Healthcare System, San Diego, CA San Diego California

Sponsors (3)

Lead Sponsor Collaborator
VA Office of Research and Development Johns Hopkins Bloomberg School of Public Health, Medical College of Wisconsin

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Patient and Physician Satisfaction Surveys on day of interventionRIAS (Roter Interaction Analysis System) Coding of videotapes for assessment of communication after intervention No
Secondary Knowledge and Understanding Questionnaires on day of intervention Compliance of study-related medications at 3 months No
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