- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02520024
Assessing the Impact of Self-directed Care, Within a Medicaid-funded Environment,on Participation and Community Living
August 10, 2015 updated by: Mark Salzer, Temple University Collaborative on Community Inclusion
This project proposed to demonstrate the effectiveness, costs, and benefits to participation and community living self-directed care programming within a financially sustainable Medicaid managed care environment.
The study examined outcomes associated with the implementation of a novel self-directed care (SDC) approach being implemented in Delaware County, Pennsylvania in which consumers were able to access a set amount of renewable funds per year and direct how they were spent, both to purchase the types and amounts of rehabilitation and treatment services they desire (and from whom they choose) and to purchase a broad-range of individualized resources and services that are generally outside of Medicaid funding (e.g., health club memberships, yoga classes, support in taking care of bills).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
120
Phase
- Not Applicable
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 to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Adults between 18-65 who are currently receiving Medicaid-reimbursed services in Delaware County, Pennsylvania for either a schizophrenia-spectrum, major depression, or bipolar disorder;
- Individuals with a cost profile within the 60-90% band of all Magellan-administered Medicaid recipients in the county (estimated service costs between $10,048 and $22,324); 3) No more than two inpatient hospitalizations of 10 days per stay, over a 2 year period prior to the study;
4) No hospitalization within 6 months of the study; 5) Ability to understand self-directed care requirement and express interest in working with a "recovery coach."
Exclusion Criteria:
- do not speak English;
- have a legal guardian;
- are unable to give informed consent
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
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Self-directed Care
Individuals in the experimental condition will work with a specially trained certified peer specialists (CPS) who will serve as "recovery coaches" to develop an individualized recovery plan that describes their goals and desires.
They will then work with the team to select both the behavioral health treatment and rehabilitation services, and the non-behavioral health materials and resources they believe are necessary to achieve their goals.
|
|
|
No Intervention: Treatment as usual
Participants in the control condition will receive services as usual.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from Baseline TU Community Participation Questionnaire to follow up at 12 months and 24 months post-baseline
Time Frame: Baseline, 12 months- and 24 months post-baseline
|
Used to gather information about the frequency of participation in multiple domains (e.g., employment, education, spirituality, leisure/recreation, attendance at self-help groups, etc.) in the last 30 days, whether or not they did the activity enough, not enough, or too much in addition to their level of satisfaction with their level of participation in the activity.
|
Baseline, 12 months- and 24 months post-baseline
|
|
Change from Baseline Recovery Assessment Scale to follow up at 12 months and 24 months post-baseline
Time Frame: Baseline, 12 months- and 24 months post-baseline
|
Baseline, 12 months- and 24 months post-baseline
|
|
|
Change from Baseline Quality of Life to 12 months and 24 months post-baseline
Time Frame: Baseline, 12 months- and 24 months post-baseline
|
Baseline, 12 months- and 24 months post-baseline
|
|
|
Change from Baseline Hopkins Symptom Checklist to 12 months and 24 months post-baseline
Time Frame: Baseline, 12 months- and 24 months post-baseline
|
Baseline, 12 months- and 24 months post-baseline
|
|
|
Change from Baseline Empowerment Scale to 12 months and 24 months post-baseline
Time Frame: Baseline, 12 months- and 24 months post-baseline
|
Baseline, 12 months- and 24 months post-baseline
|
|
|
Change from Baseline Coping Mastery Questionnaire to 12 months and 24 months post-baseline
Time Frame: Baseline, 12 months- and 24 months post-baseline
|
Baseline, 12 months- and 24 months post-baseline
|
|
|
Change from Baseline Perceived Competence for Recovery Questionnaire to 12 months and 24 months post-baseline
Time Frame: Baseline, 12 months- and 24 months post-baseline
|
Baseline, 12 months- and 24 months post-baseline
|
|
|
Change from Baseline Perceived Autonomy Support: The Mental Health Questionnaire to 12 months and 24 months post-baseline
Time Frame: Baseline, 12 months- and 24 months post-baseline
|
Baseline, 12 months- and 24 months post-baseline
|
|
|
Change from Baseline Elements of a Recovery Facilitating Systems Assessment Questionnaire - Adult Version to 12 months and 24 months post-baseline
Time Frame: Baseline, 12 months- and 24 months post-baseline
|
Baseline, 12 months- and 24 months post-baseline
|
|
|
Change from Baseline Revised Camberwell Assessment of Need Questionnaire to 12 months and 24 months post-baseline
Time Frame: Baseline, 12 months- and 24 months post-baseline
|
Baseline, 12 months- and 24 months post-baseline
|
|
|
Change from Baseline Treatment Self-Regulation Questionnaire to 12 months and 24 months post-baseline
Time Frame: Baseline, 12 months- and 24 months post-baseline
|
Baseline, 12 months- and 24 months post-baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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
January 1, 2010
Primary Completion (Actual)
March 1, 2012
Study Completion (Actual)
March 1, 2012
Study Registration Dates
First Submitted
August 1, 2015
First Submitted That Met QC Criteria
August 10, 2015
First Posted (Estimate)
August 11, 2015
Study Record Updates
Last Update Posted (Estimate)
August 11, 2015
Last Update Submitted That Met QC Criteria
August 10, 2015
Last Verified
August 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 13304
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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