Pilot Study of Video and Telephone Primary Care Visits

Telemedicine Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04496713
• Other study ID #: IRB00257994
• Status: Completed
• Phase: N/A
• Start date: January 24, 2021
• Est. completion date: December 30, 2021

Study information

• Verified date: February 2021
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: December 30, 2021
• Est. primary completion date: November 24, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Telemedicine

Intervention

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.

Locations

Country	Name	City	State
United States	Johns Hopkins Outpatient Center	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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