- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00057083
Effect of Telemedicine on Physician-Patient Communication
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
San Diego, California, United States, 92161
- VA San Diego Healthcare System, San Diego, CA
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Arm 1
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
|---|
|
Patient and Physician Satisfaction Surveys on day of interventionRIAS (Roter Interaction Analysis System) Coding of videotapes for assessment of communication after intervention
|
Secondary Outcome Measures
Outcome Measure |
|---|
|
Knowledge and Understanding Questionnaires on day of intervention Compliance of study-related medications at 3 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Zia Agha, MD MS, VA San Diego Healthcare System, San Diego, CA
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- TEL 20-036
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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