NCT03855761

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 18, 2019

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

February 25, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 27, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

February 11, 2020

Status Verified

February 1, 2020

Enrollment Period

10 months

First QC Date

February 25, 2019

Last Update Submit

February 10, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Occupational Circumstances Assessment Interview & Rating Scale (OCAIRS)

    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

Study Arms (2)

Intervention group

EXPERIMENTAL

Experimental Occupational Therapy services

Behavioral: Occupational Therapy

Comparison group

ACTIVE COMPARATOR

Treatment as usual

Behavioral: Case management; psychological services

Interventions

Detailed narrative assessment and person-centered participation in meaningful activities

Intervention group

Weekly consultation with case managers to address housing and therapy needs

Comparison group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient on a pre-determined treatment team at the outpatient mental health recruitment site

You may not qualify if:

  • Under 18
  • Pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eskenazi - Midtown Community Mental Health (James Wright Center)

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Mental Disorders

Interventions

Occupational TherapyCase Management

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPatient Care PlanningComprehensive Health CarePatient Care ManagementHealth Services Administration

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 25, 2019

First Posted

February 27, 2019

Study Start

February 18, 2019

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

February 11, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations