Back to resultsEvaluating a Telemedicine Neurological Consult Program for Drug-Induced Movement Disorders Using the RE-AIM Framework
Primary Purpose
Drug-Induced Movement Disorder
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Telemedicine Consult
In-person Consult
Sponsored by
About this trial
This is an interventional supportive care trial for Drug-Induced Movement Disorder
Eligibility Criteria
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
Sites / Locations
- University of Vermont Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Experimental
Arm Label
In-Person
Telemedicine
Arm Description
Control group
Outcomes
Primary Outcome Measures
Effectiveness; Client Satisfaction Questionnaire-8 (CSQ-8)
How satisfied are patients with the program
Secondary Outcome Measures
Effectiveness; PROMIS 29+2 V2.1
What are the impacts on patient health status
Effectiveness; referral forms and visit notes
Was there concordance in diagnosis between the MHC and movement disorder specialist
Effectiveness; visit notes
Was there an impact on care plan
Effectiveness; MHC survey and Qualitative Interviews
Were the MHCs Satisfied with the program
Full Information
NCT ID
NCT06060444
First Posted
June 10, 2023
Last Updated
September 23, 2023
Sponsor
University of Vermont
Collaborators
Neurocrine Biosciences
1. Study Identification
Unique Protocol Identification Number
NCT06060444
Brief Title
Evaluating a Telemedicine Neurological Consult Program for Drug-Induced Movement Disorders Using the RE-AIM Framework
Official Title
Evaluating a Telemedicine Neurological Consult Program for Drug-Induced Movement Disorders Using the RE-AIM Framework
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 26, 2022 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
February 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Vermont
Collaborators
Neurocrine Biosciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Drug-Induced Movement Disorder
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
In-Person
Arm Type
Other
Arm Description
Control group
Arm Title
Telemedicine
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Telemedicine Consult
Intervention Description
Neurological consultation completed remotely
Intervention Type
Other
Intervention Name(s)
In-person Consult
Intervention Description
Neurological consultation completed in-person
Primary Outcome Measure Information:
Title
Effectiveness; Client Satisfaction Questionnaire-8 (CSQ-8)
Description
How satisfied are patients with the program
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Effectiveness; PROMIS 29+2 V2.1
Description
What are the impacts on patient health status
Time Frame
12 months
Title
Effectiveness; referral forms and visit notes
Description
Was there concordance in diagnosis between the MHC and movement disorder specialist
Time Frame
12 months
Title
Effectiveness; visit notes
Description
Was there an impact on care plan
Time Frame
12 months
Title
Effectiveness; MHC survey and Qualitative Interviews
Description
Were the MHCs Satisfied with the program
Time Frame
12 months
Other Pre-specified Outcome Measures:
Title
Reach
Description
In this study, are we able to enroll a sample that is representative of the patient population that experiences DIMDs
Time Frame
12 months
Title
Adoption
Description
Are there factors that determine whether a clinician will initiate participation in this program
Time Frame
12 months
Title
Implementation
Description
What barriers exist that may determine the feasibility of the study and neurological consultation
Time Frame
12 months
Title
Maintenance; MHC survey and qualitative interviews
Description
Could a telemedicine program similar to the one we develop for this study become a part of the routine organizational practices
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Emily Houston
Phone
802-656-8974
Email
emily.houston@med.uvm.edu
Facility Information:
Facility Name
University of Vermont Medical Center
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emily Houston
Phone
802-656-8974
Email
Emily.Houston@uvm.edu
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Currently there is no plan to share individual participant data (IPD) with other researchers.
Learn more about this trial
Evaluating a Telemedicine Neurological Consult Program for Drug-Induced Movement Disorders Using the RE-AIM Framework
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