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

NCT ID: NCT04616118

Last Updated: 2021-08-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 269 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-27
• Study Completion Date: 2021-06-30

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.

Conditions

Rheumatic Disease; Cardiac Disease; Primary Care; Infectious Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: DOUBLE

Study Groups

Phone

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

Group Type: EXPERIMENTAL

Phone Visit

Intervention Type: OTHER

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

Video

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

Group Type: EXPERIMENTAL

Video Visit

Intervention Type: OTHER

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

Interventions

Phone Visit

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

Intervention Type: OTHER

Video Visit

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Maria Danila, MD, MSc, MSPH

Associate Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Maria Danila, MD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

University of Alabama at Birmingham

Birmingham, Alabama, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 30667610 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29070002 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28056832 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24685708 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28321319 (View on PubMed)

Other Identifiers

IRB-300005184

Identifier Type: -

Identifier Source: org_study_id