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

Sponsor
University of Vermont (Other)
Overall Status
Recruiting
CT.gov ID
NCT06060444
Collaborator
Neurocrine Biosciences (Industry)
30
1
2
21.2
1.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Telemedicine Consult
  • Other: In-person Consult
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Evaluating a Telemedicine Neurological Consult Program for Drug-Induced Movement Disorders Using the RE-AIM Framework
Actual Study Start Date :
Apr 26, 2022
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Feb 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Other: In-Person

Control group

Other: In-person Consult
Neurological consultation completed in-person

Experimental: Telemedicine

Other: Telemedicine Consult
Neurological consultation completed remotely

Outcome Measures

Primary Outcome Measures

  1. Effectiveness; Client Satisfaction Questionnaire-8 (CSQ-8) [12 months]

    How satisfied are patients with the program

Secondary Outcome Measures

  1. Effectiveness; PROMIS 29+2 V2.1 [12 months]

    What are the impacts on patient health status

  2. Effectiveness; referral forms and visit notes [12 months]

    Was there concordance in diagnosis between the MHC and movement disorder specialist

  3. Effectiveness; visit notes [12 months]

    Was there an impact on care plan

  4. Effectiveness; MHC survey and Qualitative Interviews [12 months]

    Were the MHCs Satisfied with the program

Other Outcome Measures

  1. Reach [12 months]

    In this study, are we able to enroll a sample that is representative of the patient population that experiences DIMDs

  2. Adoption [12 months]

    Are there factors that determine whether a clinician will initiate participation in this program

  3. Implementation [12 months]

    What barriers exist that may determine the feasibility of the study and neurological consultation

  4. Maintenance; MHC survey and qualitative interviews [12 months]

    Could a telemedicine program similar to the one we develop for this study become a part of the routine organizational practices

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • 18 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)

Exclusion Criteria:
  • Currently hospitalized

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Vermont Medical Center Burlington Vermont United States 05401

Sponsors and Collaborators

  • University of Vermont
  • Neurocrine Biosciences

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Emily Houston, Principal Investigator, University of Vermont
ClinicalTrials.gov Identifier:
NCT06060444
Other Study ID Numbers:
  • STUDY00001579
First Posted:
Sep 29, 2023
Last Update Posted:
Sep 29, 2023
Last Verified:
Sep 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 29, 2023