- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03855761
Testing a Novel Community-based Occupational Therapy Model
February 10, 2020 updated by: Sally Wasmuth, Indiana University
Improving Equitable Care With Narrative Medicine and a Novel Community-based Occupational Therapy Care Model
This study will perform a needs assessment within an outpatient mental health unit, deliver an occupational therapy model of care, track patient and organizational outcomes, and provide training to staff to implement the model.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
In this project the investigators' overall objective is to implement a narrative medicine-based occupational therapy (OT) model of care that brings client voices to the forefront of treatment planning and intervention to enhance the existing interdisciplinary system of service delivery within Midtown Community Mental Health (MCMH).
The investigators hope to accomplish this objective via the following specific aims:1) Assess current programming - particularly processes surrounding client assessment, treatment planning, intervention, care-coordination/residential placement, and discharge - within MCMH sites to better understand limitations/gaps previously identified by the site manager that impact equitable and effective treatment 2) Adapt an existing care model - the Art of Healing Wellness Model (AoHW) - to meet the needs of MCMH, implement the model using an OT practitioner, and track feasibility/acceptability outcomes.
3) Re-assess MCMH programming post implementation to identify/demonstrate change resulting from the model 4) Using OT in the role of consultant, offer training to current MCMH staff to enable implementation of the adapted AoHW by MCMH (baccalaureate level) care coordinators 5) Preliminarily evaluate usability of the adapted AoHW by MCMH staff via focus groups following training and staff implementation
Study Type
Interventional
Enrollment (Actual)
27
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Indiana
-
Indianapolis, Indiana, United States, 46202
- Eskenazi - Midtown Community Mental Health (James Wright Center)
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria
• Patient on a pre-determined treatment team at the outpatient mental health recruitment site
Exclusion Criteria
- Under 18
- Pregnant
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention group
Experimental Occupational Therapy services
|
Detailed narrative assessment and person-centered participation in meaningful activities
|
|
Active Comparator: Comparison group
Treatment as usual
|
Weekly consultation with case managers to address housing and therapy needs
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Occupational Circumstances Assessment Interview & Rating Scale (OCAIRS)
Time Frame: 12 weeks
|
The "Occupational Circumstances Assessment Interview and Rating Scale" is a semi-structured interview that measures a person's current participation in life in 12 areas:roles, habits, personal causation, values, interests, skills, short-term goals, long-term goals, interpretation of past experiences, physical environment, social environment, & readiness for change.
The assessment provides an overall quantitative summed score of participation ranging from 12 to 48 with a higher number indicating greater participation as well as individual scores of 1-4 for each subsection.
|
12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 18, 2019
Primary Completion (Actual)
December 1, 2019
Study Completion (Actual)
December 1, 2019
Study Registration Dates
First Submitted
February 25, 2019
First Submitted That Met QC Criteria
February 25, 2019
First Posted (Actual)
February 27, 2019
Study Record Updates
Last Update Posted (Actual)
February 11, 2020
Last Update Submitted That Met QC Criteria
February 10, 2020
Last Verified
February 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- swasmuth
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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