NCT02520024

Brief 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).

Trial Health

100
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2010

Typical duration for not_applicable

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

August 1, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 11, 2015

Completed
Last Updated

August 11, 2015

Status Verified

August 1, 2015

Enrollment Period

2.2 years

First QC Date

August 1, 2015

Last Update Submit

August 10, 2015

Conditions

Keywords

self-directed careserious mental illness

Outcome Measures

Primary Outcomes (11)

  • 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

  • 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

  • Change from Baseline Quality of Life to 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

    Baseline, 12 months- and 24 months post-baseline

  • Change from Baseline Empowerment Scale to 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

    Baseline, 12 months- and 24 months post-baseline

  • Change from Baseline Perceived Competence for Recovery Questionnaire to 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

    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

    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

    Baseline, 12 months- and 24 months post-baseline

  • Change from Baseline Treatment Self-Regulation Questionnaire to 12 months and 24 months post-baseline

    Baseline, 12 months- and 24 months post-baseline

Study Arms (2)

Self-directed Care

EXPERIMENTAL

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.

Behavioral: self-directed care

Treatment as usual

NO INTERVENTION

Participants in the control condition will receive services as usual.

Interventions

Self-directed Care

Eligibility Criteria

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

You may qualify if:

  • 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;
  • \) 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."

You may not qualify if:

  • do not speak English;
  • have a legal guardian;
  • are unable to give informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Depressive Disorder, MajorBipolar DisorderSchizophrenia

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental DisordersBipolar and Related DisordersSchizophrenia Spectrum and Other Psychotic Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

August 1, 2015

First Posted

August 11, 2015

Study Start

January 1, 2010

Primary Completion

March 1, 2012

Study Completion

March 1, 2012

Last Updated

August 11, 2015

Record last verified: 2015-08