Evaluating a Telemedicine Neurological Consult Program for Drug-Induced Movement Disorders Using the RE-AIM Framework

NCT06060444 | Completed

• 1 other identifier: STUDY00001579
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

In this pilot study, the investigators will evaluate care delivery via telemedicine to individuals with drug-induced movement disorders (DIMDs). DIMDs can be disabling, and prevention is important; but these disorders are often under-reported, under-recognized and poorly managed. Interprofessional telemedicine for movement disorders is feasible and may provide similar care as in-person visits; however, the majority of studies to date have shown benefit in Parkinson's disease and further validation in other movement disorders is necessary. In this randomized controlled trial the aim is to study the acceptability, feasibility, and patient and clinician outcomes when a neurological consultation is provided for patients with DIMDs either in-person or through telemedicine. The investigators will apply the evaluation framework RE-AIM (Reach and Effectiveness, Adoption, Implementation, and Maintenance) to comprehensively assess the factors that may impact study success and program implementation. Mixed methods will be implemented to gather outcome data from mental health clinicians that refer patients and the patient participants.

Conditions

Drug-Induced Movement Disorder

Outcome Measures

Primary Outcomes (1)

• Effectiveness; Client Satisfaction Questionnaire-8 (CSQ-8)

  How satisfied are patients with the program

  12 months

Secondary Outcomes (4)

• Effectiveness; PROMIS 29+2 V2.1

  12 months

• Effectiveness; referral forms and visit notes

  12 months

• Effectiveness; visit notes

  12 months

• Effectiveness; MHC survey and Qualitative Interviews

  12 months

Other Outcomes (4)

• Reach

  12 months

• Adoption

  12 months

• Implementation

  12 months

Study Arms (2)

In-Person

OTHER

Control group

Other: In-person Consult

Telemedicine

EXPERIMENTAL

Other: Telemedicine Consult

Interventions

Telemedicine Consult OTHER

Neurological consultation completed remotely

Telemedicine

In-person Consult OTHER

Neurological consultation completed in-person

In-Person

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years or older
• Willing and able to provide consent
• Willing to have their Mental Health Clinician (MHC) share sensitive clinical information with the Neurology team
• Able to travel to Neurology clinic
• Have connectivity to Zoom using wi-fi or cellular data, either at home or a comfortable and private setting (such as MHC office)

You may not qualify if:

• Currently hospitalized
• Neurologist determines patient requires care outside of the scope of the study

Sponsors & Collaborators

• University of Vermont: lead
• Neurocrine Biosciences: collaborator

Study Sites (1)

University of Vermont Medical Center

Burlington, Vermont, 05401, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 10, 2023
• First Posted: September 29, 2023
• Study Start: April 26, 2022
• Primary Completion: September 20, 2024
• Study Completion: October 31, 2024
• Last Updated: November 5, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)