Pilot Study of Video and Telephone Primary Care Visits

Study Overview
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Brief Summary
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The inability to access and use smartphones or camera-outfitted internet-connected devices during the COVID-19 pandemic relegates certain patients to receive audio-only telemedicine instead of audio/video-based telemedicine. The investigators are conducting a randomized controlled trial in order to characterize patient and provider attitudes towards these two modalities of care and to test the feasibility of a new model to make tablets for video-based care accessible to those who need that. The investigators hypothesize that patient and provider satisfaction will be higher with video-based telehealth when compared to phone-based telehealth.

Official Title
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Pilot Study - Randomized Controlled Trial of Video and Telephone Primary Care Visits

Conditions
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Telemedicine

Intervention / Treatment
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* Other: Internet-connected computer tablet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients scheduled for telephone-based visits who are doing so because of a lack of ability to conduct a video visit (i.e. no tablet/laptop; no access to internet) who live in Baltimore City Exclusion Criteria: Patients with significant visual or hearing impairment Patients that have legal guardians or who are marked as lacking healthcare decision-making capacity Patients that have not selected English as their preferred language

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Telemedicine - Phone<br>Patients will continue with their telephone-based telemedicine visit as scheduled. There will be no change to their care. Patients will receive a survey by mail about the visit. | |
| Experimental: Telemedicine - Audio/Video<br>Patients will be given an internet-connected tablet to have their upcoming visit with their physician by audio/video. A survey can be completed on the tablet. The devices will be sent back to the research time after their single use. | Other: Internet-connected computer tablet<br>* An internet-connected tablet provided to patient for upcoming visit with physician by audio/video which can also be used to complete a survey.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Provider rating as assessed by the Consumer Assessment of Healthcare Providers and Systems question on provider rating | Provider rating will be assessed with the Consumer Assessment of Healthcare Providers and Systems question on provider rating of 0-10; 0 being worst provider possible and 10 being best provider possible. | Within 2 weeks of the study visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Satisfaction with telemedicine visit for patient as assessed by a Likert scale | Satisfaction with telemedicine visit for patient will be assessed with Likert-scale questions related to satisfaction. Satisfaction (1=strongly disagree to 5=strongly agree). In general, I was satisfied with using a video or phone call for this visit I could explain my medical problems well enough Talking to the doctor was as satisfying as talking in person Overall score 3 to 15 with higher scores signifying better satisfaction. | Within 2 weeks of the study visit | 
| Satisfaction with telemedicine visit for provider as assessed by a Likert scale | Satisfaction with telemedicine visit for provider will be assessed with Likert-scale questions related to satisfaction. [1=Strongly Disagree. 5=Strongly Agree]. In general, I was satisfied with using telemedicine for this visit Talking to the patient was as satisfying as talking in person. Overall score 2 to 10 with higher scores signifying better satisfaction. | Within 2 weeks of the study visit | 
| Efficacy of telemedicine visit for provider as assessed by a Likert scale | Efficacy of telemedicine visit for provider will be assessed with Likert-scale questions related to efficacy. [1=Strongly Disagree. 5=Strongly Agree]. b. I was able to understand the patient's explanation of their medical problems well enough. c. In general, this telemedicine visit was effective in improving this patient's medical care d. An in-person visit would likely have provided additional clinically-relevant information e. An in-person visit would likely have led to a change in management | Within 2 weeks of the study visit | 
| Provider communication as assessed by yes/no question | The ability of a provider to communicate will be assessed by patients with the yes/no question of a modified version of the Consumer Assessment of Healthcare Providers and Systems questionnaire related to communication. Did this provider explain things in a way that was easy to understand? Yes/No | Within 2 weeks of the study visit | 
| Provider listening as assessed by yes/no question | Provider listening will be assessed by patients with the yes/no question of a modified version of the Consumer Assessment of Healthcare Providers and Systems questionnaire related to listening. Did this provider listen carefully to you? Yes/No | Within 2 weeks of the study visit | 
| Provider respect as assessed by yes/no question | Provider respect will be assessed by patients with the yes/no question of a modified version of the Consumer Assessment of Healthcare Providers and Systems questionnaire relating to respect. Did this provider show respect for what you had to say? Yes/No | Within 2 weeks of the study visit | 
| Provider time spent as assessed by yes/no question | Provider time spent will be assessed by patients with the yes/no question of a modified version of the Consumer Assessment of Healthcare Providers and Systems questionnaire relating to time spent during the clinical encounter. Did this provider spend enough time with you? Yes/No | Within 2 weeks of the study visit | 
| Patient health rating as assessed by a likert scale | Patient health will be assessed with Likert-scale questions related to patient health. In general, how would you rate your overall health? Excellent Very good Good Fair Poor In general, how would you rate your overall mental or emotional health? Excellent Very good Good Fair Poor Overall score 2 to 10 with lower scores signifying better health. | Within 2 weeks of the study visit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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telemedicine, audio/video, telephone, primary care