NCT04496713

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 29, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 3, 2020

Completed
6 months until next milestone

Study Start

First participant enrolled

January 24, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 24, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2021

Completed
Last Updated

February 9, 2022

Status Verified

February 1, 2021

Enrollment Period

10 months

First QC Date

July 29, 2020

Last Update Submit

February 8, 2022

Conditions

Keywords

telemedicineaudio/videotelephoneprimary care

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

  • Satisfaction with telemedicine visit for patient as assessed by a Likert scale

    Within 2 weeks of the study visit

  • Satisfaction with telemedicine visit for provider as assessed by a Likert scale

    Within 2 weeks of the study visit

  • Efficacy of telemedicine visit for provider as assessed by a Likert scale

    Within 2 weeks of the study visit

  • Provider communication as assessed by yes/no question

    Within 2 weeks of the study visit

  • Provider listening as assessed by yes/no question

    Within 2 weeks of the study visit

  • +3 more secondary outcomes

Study Arms (2)

Telemedicine - Phone

NO INTERVENTION

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.

Telemedicine - Audio/Video

EXPERIMENTAL

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

Interventions

An internet-connected tablet provided to patient for upcoming visit with physician by audio/video which can also be used to complete a survey.

Telemedicine - Audio/Video

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins Outpatient Center

Baltimore, Maryland, 21287, United States

Location

Study Officials

  • Jeremy A Epstein, MD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR
  • Casey Overby Taylor, PhD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 29, 2020

First Posted

August 3, 2020

Study Start

January 24, 2021

Primary Completion

November 24, 2021

Study Completion

December 30, 2021

Last Updated

February 9, 2022

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will share

Protocol and analysis plan, without any protected health information (PHI), can be shared on request via email.

Shared Documents
STUDY PROTOCOL, SAP

Locations