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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04616118
Other study ID # IRB-300005184
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 27, 2020
Est. completion date June 30, 2021

Study information

Verified date August 2021
Source University of Alabama at Birmingham
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 269
Est. completion date June 30, 2021
Est. primary completion date January 15, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Other:
Phone Visit
Participants randomized to this arm will receive usual care via telephone only
Video Visit
Participants randomized to this arm will receive usual care via video call

Locations

Country Name City State
United States University of Alabama at Birmingham Birmingham Alabama

Sponsors (1)

Lead Sponsor Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View 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. — View 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. — View Citation

Wade V, Smith AC. Research methods and methodology in telemedicine. J Telemed Telecare. 2017 Oct;23(9):757-758. doi: 10.1177/1357633X17733088. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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