Assessing the Impact of Self-directed Care, Within a Medicaid-funded Environment,on Participation and Community Living

Schizophrenia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02520024
• Other study ID #: 13304
• Status: Completed
• Phase: N/A
• First received: August 1, 2015
• Last updated: August 10, 2015
• Start date: January 2010
• Est. completion date: March 2012

Study information

• Verified date: August 2015
• Source: Temple University Collaborative on Community Inclusion
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. 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;

2. 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:

1. do not speak English;

2. have a legal guardian;

3. are unable to give informed consent

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Bipolar Disorder
• Depressive Disorder, Major
• Major Depression
• Schizophrenia

Intervention

Behavioral:
• self-directed care

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Temple University Collaborative on Community Inclusion

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline TU Community Participation Questionnaire to follow up at 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	No
Primary	Change from Baseline Recovery Assessment Scale to follow up at 12 months and 24 months post-baseline		Baseline, 12 months- and 24 months post-baseline	No
Primary	Change from Baseline Quality of Life to 12 months and 24 months post-baseline		Baseline, 12 months- and 24 months post-baseline	No
Primary	Change from Baseline Hopkins Symptom Checklist to 12 months and 24 months post-baseline		Baseline, 12 months- and 24 months post-baseline	No
Primary	Change from Baseline Empowerment Scale to 12 months and 24 months post-baseline		Baseline, 12 months- and 24 months post-baseline	No
Primary	Change from Baseline Coping Mastery Questionnaire to 12 months and 24 months post-baseline		Baseline, 12 months- and 24 months post-baseline	No
Primary	Change from Baseline Perceived Competence for Recovery Questionnaire to 12 months and 24 months post-baseline		Baseline, 12 months- and 24 months post-baseline	No
Primary	Change from Baseline Perceived Autonomy Support: The Mental Health Questionnaire to 12 months and 24 months post-baseline		Baseline, 12 months- and 24 months post-baseline	No
Primary	Change from Baseline Elements of a Recovery Facilitating Systems Assessment Questionnaire - Adult Version to 12 months and 24 months post-baseline		Baseline, 12 months- and 24 months post-baseline	No
Primary	Change from Baseline Revised Camberwell Assessment of Need Questionnaire to 12 months and 24 months post-baseline		Baseline, 12 months- and 24 months post-baseline	No
Primary	Change from Baseline Treatment Self-Regulation Questionnaire to 12 months and 24 months post-baseline		Baseline, 12 months- and 24 months post-baseline	No