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OpenTrials
Completed

NCT Number: NCT06060444

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Vermont Medical Center

Burlington, Vermont, 05401, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Telemedicine Consult

Other

Neurological consultation completed remotely

In-person Consult

Other

Neurological consultation completed in-person

Primary outcomes

  1. Effectiveness; Client Satisfaction Questionnaire-8 (CSQ-8)

    Time frame: 12 months

    How satisfied are patients with the program

Secondary outcomes

  1. Effectiveness; PROMIS 29+2 V2.1

    Time frame: 12 months

    What are the impacts on patient health status

  2. Effectiveness; referral forms and visit notes

    Time frame: 12 months

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

  3. Effectiveness; visit notes

    Time frame: 12 months

    Was there an impact on care plan

  4. Effectiveness; MHC survey and Qualitative Interviews

    Time frame: 12 months

    Were the MHCs Satisfied with the program

Other outcomes

  1. Reach

    Time frame: 12 months

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

  2. Adoption

    Time frame: 12 months

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

  3. Implementation

    Time frame: 12 months

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

  4. Maintenance; MHC survey and qualitative interviews

    Time frame: 12 months

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

Sponsors and collaborators

Lead sponsor

University of Vermont

Other

Collaborators

  • Neurocrine Biosciences

Registry information

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Sep 29, 2023
Registry last updated
Nov 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.