TelemedicineNCT00057083
Effect of Telemedicine on Physician-Patient Communication
A study testing Telemedicine Care in people with Telemedicine and Patient Satisfaction, run by US Department of Veterans Affairs at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Telemedicine, Patient Satisfaction, Remote Consultation
- What is being tested?
- Telemedicine Care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 221 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2003to Oct 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
VA San Diego Healthcare System, San Diego, CA
San Diego, California, 92161
About this study
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.
Read the 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.
- Conditions
- Telemedicine, Patient Satisfaction, Remote Consultation
- Being tested
- Telemedicine Care
- Keywords
- Telemedicine, Remote consultation, Patient Satisfaction, Physician patient relations, Provider satisfaction, Doctor-patient relations
- Medical subject headings
- Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telemedicine CareOther
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Other | Not described Receives: Other: Telemedicine Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient and Physician Satisfaction Surveys on day of interventionRIAS (Roter Interaction Analysis System) Coding of videotapes for assessment of communication after intervention
Secondary outcomes (1)
Knowledge and Understanding Questionnaires on day of intervention Compliance of study-related medications at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2003 (estimated)
- Study startMar 2003
- Primary completionOct 2007
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TelemedicineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 221 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Zia Agha, MD MS, Principal investigator, VA San Diego Healthcare System, San Diego, CA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00057083
- Sponsor's protocol ID
- TEL 20-036
- Status last verified
- Feb 2008
- First submitted
- 27 Mar 2003
- Last updated
- 7 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Telemedicine on Physician-Patient Communication
- ClinicalTrials.gov ID
- NCT00057083
- Acronym / sponsor ID
- TEL 20-036
- Conditions
- Telemedicine, Patient Satisfaction, Remote Consultation
- Keywords
- Telemedicine, Remote consultation, Patient Satisfaction, Physician patient relations, Provider satisfaction, Doctor-patient relations
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 221 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Collaborators
- Medical College of Wisconsin, Johns Hopkins Bloomberg School of Public Health
- Study start
- Mar 2003
- Primary completion
- Oct 2007 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 28 Mar 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Other | Other: Telemedicine Care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telemedicine Care | Other | Arm 1 |
Primary outcome
Patient and Physician Satisfaction Surveys on day of interventionRIAS (Roter Interaction Analysis System) Coding of videotapes for assessment of communication after intervention
1 secondary outcome
Knowledge and Understanding Questionnaires on day of intervention Compliance of study-related medications at 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zia Agha, MD MS principal investigator
VA San Diego Healthcare System, San Diego, CA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telemedicine Care in people with Telemedicine and Patient Satisfaction, run by US Department of Veterans Affairs at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient and Physician Satisfaction Surveys on day of interventionRIAS (Roter Interaction Analysis System) Coding of videotapes for assessment of communication after intervention. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2015.