Pilot Study of Video and Telephone Primary Care Visits

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

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.

Study Overview

• Status: Completed
• Conditions: Telemedicine
• Intervention / Treatment: Other: Internet-connected computer tablet

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins Outpatient Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Telemedicine - Phone; 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; 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; An internet-connected tablet provided to patient for upcoming visit with physician by audio/video which can also be used to complete a survey.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Investigators: Principal Investigator: Jeremy A Epstein, MD, Johns Hopkins University; Principal Investigator: Casey Overby Taylor, PhD, Johns Hopkins University

Study record dates

Study Major Dates

• Study Start (Actual): January 24, 2021
• Primary Completion (Actual): November 24, 2021
• Study Completion (Actual): December 30, 2021

Study Registration Dates

• First Submitted: July 29, 2020
• First Submitted That Met QC Criteria: July 29, 2020
• First Posted (Actual): August 3, 2020

Study Record Updates

• Last Update Posted (Actual): February 9, 2022
• Last Update Submitted That Met QC Criteria: February 8, 2022
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: primary care; telemedicine; telephone; audio/video
• Other Study ID Numbers: IRB00257994

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Protocol and analysis plan, without any protected health information (PHI), can be shared on request via email.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No