NCT04616118

Brief Summary

Given the current public health crisis the use of telehealth consultation visits including phone-only and video visits has exponentially increased. This study will investigate if the conduct of telehealth phone only visits is non-inferior in terms of patient satisfaction/experience, adherence to post-visit recommendations such as medications, blood work and other medical testing, follow up care, when compared to the conduct of video delivered telehealth visits. Patients will be randomized to receive a routine care visit via phone only vs. video.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
269

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2020

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 27, 2020

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 29, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 4, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
Last Updated

August 13, 2021

Status Verified

August 1, 2021

Enrollment Period

8 months

First QC Date

October 29, 2020

Last Update Submit

August 12, 2021

Conditions

Rheumatic DiseaseCardiac DiseasePrimary CareInfectious Disease

Outcome Measures

Primary Outcomes (1)

  • Patient Satisfaction

    Patient satisfaction with type of visit. Satisfaction will be measured using the 11-point ARHQ-CAHPS patient satisfaction instrument.

    36 hours post visit

Study Arms (2)

Phone

EXPERIMENTAL

Participants randomized to this arm will receive usual care via telephone only

Other: Phone Visit

Video

EXPERIMENTAL

Participants randomized to this arm will receive usual care via video call

Other: Video Visit

Interventions

Phone VisitOTHER

Participants randomized to this arm will receive usual care via telephone only

Phone
Video VisitOTHER

Participants randomized to this arm will receive usual care via video call

Video

Eligibility Criteria

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

You may qualify if:

  • Access to a phone and video call capacity
  • A minimum of 1 visits in the last year with their provider
  • Medicare/Medicaid eligible

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Related Publications (5)

  • Donelan K, Barreto EA, Sossong S, Michael C, Estrada JJ, Cohen AB, Wozniak J, Schwamm LH. Patient and clinician experiences with telehealth for patient follow-up care. Am J Manag Care. 2019 Jan;25(1):40-44.

    PMID: 30667610BACKGROUND

  • Wade V, Smith AC. Research methods and methodology in telemedicine. J Telemed Telecare. 2017 Oct;23(9):757-758. doi: 10.1177/1357633X17733088. No abstract available.

    PMID: 29070002BACKGROUND

  • Batsis JA, Pletcher SN, Stahl JE. Telemedicine and primary care obesity management in rural areas - innovative approach for older adults? BMC Geriatr. 2017 Jan 5;17(1):6. doi: 10.1186/s12877-016-0396-x.

    PMID: 28056832BACKGROUND

  • Wade VA, Eliott JA, Hiller JE. Clinician acceptance is the key factor for sustainable telehealth services. Qual Health Res. 2014 May;24(5):682-94. doi: 10.1177/1049732314528809. Epub 2014 Mar 31.

    PMID: 24685708BACKGROUND

  • Kruse CS, Soma M, Pulluri D, Nemali NT, Brooks M. The effectiveness of telemedicine in the management of chronic heart disease - a systematic review. JRSM Open. 2017 Feb 1;8(3):2054270416681747. doi: 10.1177/2054270416681747. eCollection 2017 Mar.

    PMID: 28321319BACKGROUND

MeSH Terms

Conditions

Rheumatic DiseasesHeart DiseasesCommunicable Diseases

Condition Hierarchy (Ancestors)

Musculoskeletal DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesCardiovascular DiseasesInfectionsDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Maria Danila, MD

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Medicine

Study Record Dates

First Submitted

October 29, 2020

First Posted

November 4, 2020

Study Start

May 27, 2020

Primary Completion

January 15, 2021

Study Completion

June 30, 2021

Last Updated

August 13, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)