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Comparing Modes of Telehealth Delivery: Phone vs. Video Visits (ASSIST)

Primary Purpose

Rheumatic Disease, Cardiac Disease, Primary Care

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Phone Visit
Video Visit
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Rheumatic Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

•Individuals not meeting inclusion criteria

Sites / Locations

  • University of Alabama at Birmingham

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Phone

Video

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
October 29, 2020
Last Updated
August 12, 2021
Sponsor
University of Alabama at Birmingham
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1. Study Identification

Unique Protocol Identification Number
NCT04616118
Brief Title
Comparing Modes of Telehealth Delivery: Phone vs. Video Visits (ASSIST)
Official Title
Comparing Modes of Telehealth Delivery:Phone vs. Video Visits
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
May 27, 2020 (Actual)
Primary Completion Date
January 15, 2021 (Actual)
Study Completion Date
June 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Telemedicine and an emerging field of novel care delivery modalities, which encompasses all forms of remote-based care. These include asynchronous (store-and-forward) and consultative care by specialists, mobile-device based care, and real-time video chat, and synchronous telemedicine. Health care services delivered remotely through telecommunications and video technology is steadily increasing as technology evolves and access becomes more widely available. The increasing availability of personal technology - 89% Americans have internet access, 77% are online daily - offers patients and clinicians the opportunity to utilize real-time virtual communication to enhance access for patients when transportation challenges, schedules, or physical disability make office visits difficult in any geography. With the increased use of technology in healthcare, much emphasis has been placed on telemedicine as it can extend the services of providers to remote locations and overcome the barrier of proximity. This expands access to care and has the potential of making healthcare services more convenient for many patients who otherwise might suffer access barriers. It is increasingly evident that telehealth can improve access to healthcare services and specialists; prevent unnecessary delays in receiving care, and facilitate coordinated care and interprofessional collaboration. The World Health Organization affirms the efficacy of telehealth as an effective service delivery model for professionals. Telemedicine has been shown to improve health outcomes, increase communication with providers, increase access to high-quality service, decrease travel time, decrease missed appointments, decrease wait time, decrease repeat admissions, increase self-awareness, increase medication adherence, and increase self-monitoring of chronic conditions. The technical quality of telehealth consultation (e.g. audio and visual quality of a videoconference) has been shown to influence clinicians' willingness to practice in this manner and the satisfaction of users. A recent systematic review on patient satisfaction with telemedicine found that patient satisfaction can be associated with the modality of telehealth, but factors of effectiveness and efficiency are mixed. Telehealth is a feasible option to expand practices to remote areas without having to relocate or expand. Understanding the perceived relative value of different modes of healthcare services may help to shape the use of virtual or remote healthcare technologies. System learning that demonstrates the value of different types of "visits" for the system and the patient is essential.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatic Disease, Cardiac Disease, Primary Care, Infectious Disease

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
269 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Phone
Arm Type
Experimental
Arm Description
Participants randomized to this arm will receive usual care via telephone only
Arm Title
Video
Arm Type
Experimental
Arm Description
Participants randomized to this arm will receive usual care via video call
Intervention Type
Other
Intervention Name(s)
Phone Visit
Intervention Description
Participants randomized to this arm will receive usual care via telephone only
Intervention Type
Other
Intervention Name(s)
Video Visit
Intervention Description
Participants randomized to this arm will receive usual care via video call
Primary Outcome Measure Information:
Title
Patient Satisfaction
Description
Patient satisfaction with type of visit. Satisfaction will be measured using the 11-point ARHQ-CAHPS patient satisfaction instrument.
Time Frame
36 hours post visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Access to a phone and video call capacity A minimum of 1 visits in the last year with their provider Medicare/Medicaid eligible Exclusion Criteria: •Individuals not meeting inclusion criteria
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria Danila, MD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30667610
Citation
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.
Results Reference
background
PubMed Identifier
29070002
Citation
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.
Results Reference
background
PubMed Identifier
28056832
Citation
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.
Results Reference
background
PubMed Identifier
24685708
Citation
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.
Results Reference
background
PubMed Identifier
28321319
Citation
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.
Results Reference
background

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Comparing Modes of Telehealth Delivery: Phone vs. Video Visits (ASSIST)

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