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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Vermont
-
Burlington, Vermont, United States, 05401
- University of Vermont Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: In-Person
Control group
|
Neurological consultation completed in-person
|
|
Experimental: Telemedicine
|
Neurological consultation completed remotely
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Effectiveness; Client Satisfaction Questionnaire-8 (CSQ-8)
Time Frame: 12 months
|
How satisfied are patients with the program
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Effectiveness; PROMIS 29+2 V2.1
Time Frame: 12 months
|
What are the impacts on patient health status
|
12 months
|
|
Effectiveness; referral forms and visit notes
Time Frame: 12 months
|
Was there concordance in diagnosis between the MHC and movement disorder specialist
|
12 months
|
|
Effectiveness; visit notes
Time Frame: 12 months
|
Was there an impact on care plan
|
12 months
|
|
Effectiveness; MHC survey and Qualitative Interviews
Time Frame: 12 months
|
Were the MHCs Satisfied with the program
|
12 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
12 months
|
|
Adoption
Time Frame: 12 months
|
Are there factors that determine whether a clinician will initiate participation in this program
|
12 months
|
|
Implementation
Time Frame: 12 months
|
What barriers exist that may determine the feasibility of the study and neurological consultation
|
12 months
|
|
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
|
12 months
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00001579
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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