Pilot Study of Video and Telephone Primary Care Visits

Sponsor
Johns Hopkins University (Other)
Overall Status
Completed
CT.gov ID
NCT04496713
Collaborator
(none)
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Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: Internet-connected computer tablet
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
15 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
Pilot Study - Randomized Controlled Trial of Video and Telephone Primary Care Visits
Actual Study Start Date :
Jan 24, 2021
Actual Primary Completion Date :
Nov 24, 2021
Actual Study Completion Date :
Dec 30, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Provider rating as assessed by the Consumer Assessment of Healthcare Providers and Systems question on provider rating [Within 2 weeks of the study visit]

    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.

Secondary Outcome Measures

  1. Satisfaction with telemedicine visit for patient as assessed by a Likert scale [Within 2 weeks of the study visit]

    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.

  2. Satisfaction with telemedicine visit for provider as assessed by a Likert scale [Within 2 weeks of the study visit]

    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.

  3. Efficacy of telemedicine visit for provider as assessed by a Likert scale [Within 2 weeks of the study visit]

    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

  4. Provider communication as assessed by yes/no question [Within 2 weeks of the study visit]

    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

  5. Provider listening as assessed by yes/no question [Within 2 weeks of the study visit]

    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

  6. Provider respect as assessed by yes/no question [Within 2 weeks of the study visit]

    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

  7. Provider time spent as assessed by yes/no question [Within 2 weeks of the study visit]

    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

  8. Patient health rating as assessed by a likert scale [Within 2 weeks of the study visit]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Johns Hopkins Outpatient Center Baltimore Maryland United States 21287

Sponsors and Collaborators

  • Johns Hopkins University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT04496713
Other Study ID Numbers:
  • IRB00257994
First Posted:
Aug 3, 2020
Last Update Posted:
Feb 9, 2022
Last Verified:
Feb 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Johns Hopkins University

Study Results

No Results Posted as of Feb 9, 2022