- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07375485
Occupational Therapy for Mental Health and Engagement in Neurorehabilitation (OT for ME)
Multifaceted Implementation Program for Occupational Therapy Practitioners Addressing Anxiety and Depressive Symptoms in Home and Community Care
Study Overview
Status
Intervention / Treatment
Detailed Description
This Hybrid Type 3 convergent mixed methods pilot study examines implementation processes, practitioner experiences, and stakeholder perspectives associated with participation in a multifaceted implementation program designed to support OTPs in addressing mental health among adults with ABI in home and community-based care.
Participating OTPs complete a virtual, self-paced, five-module educational training focused on evidence-based mental health screening and intervention strategies relevant to ABI. Additional implementation support activities include periodic check-ins, mentoring and coaching as part of routine clinical practice, fidelity monitoring, and audit and feedback through electronic health record review.
Aim 1. Describe reach, adoption, implementation experiences, and maintenance of mental health-related occupational therapy practices among OTPs participating in a multifaceted implementation training in home and community-based neurorehabilitation.
Aim 2. Explore implementation mechanisms and contextual factors influencing observed implementation experiences, informed by the Practical, Robust Implementation and Sustainability Model (PRISM).
Aim 3. Describe perspectives of key stakeholders, including interdisciplinary team members, administrators, and people with ABI, regarding their experiences of OT addressing mental health.
The primary outcomes of the study are changes in OT practitioners' knowledge, self-efficacy, and mental health practice skills (defined according to the Reach Effectiveness Adoption Implementation and Maintenance [RE-AIM] Model). These outcomes will be assessed through electronic health record review, fidelity monitoring, surveys, and focus groups.
Interdisciplinary stakeholders, including social work, neuropsychology, administrative leadership, patients with ABI and caregivers will participate in focus groups and interviews to provide perspectives on feasibility, acceptability, and perceived impact of the training within the clinical setting.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Colorado
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Denver, Colorado, United States, 80222
- Rehab Without Walls Denver, CO
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Fort Collins, Colorado, United States, 80523
- Colorado State University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion criteria are at the level of the therapist:
- State-licensed occupational therapists (OTs) or occupational therapy assistants (OTAs) in the United States
- OTs or OTAs who work in home or community neurorehabilitation practice settings and treat adults (18 years of age or older) with acquired brain injury (defined as any traumatic or non-traumatic injury to the brain after birth)
Exclusion Criteria:
- OTs or OTAs without a state license to practice OT
- OTs or OTAs who do not work in home or community neurorehabilitation
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Occupational therapy practitioners
OTPs will complete training and coaching sessions on evidence-based OT mental health screening (anxiety and depressive symptoms and loneliness) and intervention practices (cognitive behavioral therapy, problem-solving therapy, motivational interviewing, behavior change, and self-regulation), receive job and decision aid templates, attend monthly check-insas a team and with clinical experts in OT mental healthcare, and fidelity monitoring and observation.
Additional strategies may be identified through interviews or focus groups by tailoring implementation strategies further to the local context.
Interdisciplinary team members will only undergo the training and share their experiences and perceptions of OT's role in mental health during neurorehabilitation.
|
OTPs will complete training and coaching sessions on evidence-based OT mental health screening (anxiety and depressive symptoms and loneliness) and intervention practices (cognitive behavioral therapy, problem-solving therapy, motivational interviewing, behavior change, and self-regulation), receive job and decision aid templates, attend monthly check-insas a team and with clinical experts in OT mental healthcare, and fidelity monitoring and observation.
Additional strategies may be identified by the OT practitioners in the study through interviews or focus groups, allowing for further tailoring of implementation strategies to the local context.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Implementation outcomes
Time Frame: 24 months
|
The primary outcome of this study is the adoption of evidence-based mental health screening and intervention practices among occupational therapy practitioners after participating in a multifaceted implementation program. We have defined adoption as a dichotomous outcome (adopted vs. did not adopt), with the a priori established benchmark for adoption as the observed use of evidence-based mental health screening tools and intervention practices with 90% of clients in 10 or more sessions across the client's length of stay. We will measure adoption using directed content analysis of electronic health record data, on-site observations, and self-reported use of screening and intervention practices from qualitative focus groups and interviews. |
24 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Identify implementation mechanisms and factors influencing implementation outcomes
Time Frame: 24 months
|
The secondary outcome of this study is to understand factors that influenced the adoption of evidence-based mental health screening and intervention practices among occupational therapy practitioners after participation in a multifaceted implementation program. Factors influencing the adoption of mental health screening and intervention practices will be measured qualitatively through the identification of themes that influence whether practitioners adopt the mental health screening tools and interventions. We will thematically analyze focus group and interview transcripts with inductive and deductive (from the Practical, Robust Implementation and Sustainability Model [PRISM] and use of a codebook) codes to identify the themes. |
24 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB #: 6989
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
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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