- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02299492
Person-Centered Care Planning and Service Engagement (PCCP)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Service disengagement is one of the most pervasive and challenging problems currently facing the mental health care system. No matter how effective mental health services are now or become in the future, they are of little value should persons with mental illnesses continue to choose not to receive them. Consumers have attributed their disengagement from care to having poor alliances with care providers, including experiences of not being listened to and not being offered the opportunity to make decisions and collaborate in their own treatment. In response, the mental health system is moving toward a more person-centered model, based upon recovery principles, to engage consumers more actively in their care. While states have embraced this model in theory, they are now looking for guidance as to how best to implement this model in practice, including how to maximize service quality and consumer outcomes given the limited resources available to them for workforce development.
The proposed study tackles this pressing issue by testing the effectiveness of Person-Centered Care Planning (PCCP). By targeting treatment planning - a process that is common across clinical interventions - PCCP has the potential to enhance evidence based practices. PCCP is a field-tested intervention designed to maximize consumer choice and ownership of the treatment process.Providers collaborate with consumers to develop customized plans that identify life goals and potential barriers to achieving them. PCCP is implemented agency-wide through clinical supervisor trainings, which provide an experiential teaching program and tools to translate the practice to frontline clinicians.
Our controlled trial will randomize community mental health centers from two states to receive either PCCP or treatment as usual. The study will conduct surveys of agency providers to assess the impact of PCCP on transformational leadership, recovery orientation, and organizational readiness. Provider PCCP competency associated with the intervention will be measured via provider surveys and client medical record review. Client outcomes will include service engagement, satisfaction with services, adherence, employment, housing, and social support. Client outcomes will be measured using secondary data from agency, state and federal datasets. Qualitative inquiry will be used to better understand the care planning and implementation process associated with the intervention. Focus groups will be conducted with providers and consumers in the experimental sites. The specific aims of the study are:
- Assess the effectiveness of PCCP. H1: Relative to treatment as usual, a significantly larger proportion of participants receiving PCCP will engage in services, have greater satisfaction with services, and have improved outcomes.
- Assess the effect of organizational factors on the implementation and effectiveness of PCCP
- Use qualitative methods to understand how care planning impacts service engagement and how implementation processes influence organizational and provider level behavior.
Designed to bridge the science to services gap, this statewide study focuses on how agencies can bring about the wholesale transformation needed to deliver sustainable person-centered care. This study is the first of its kind to examine the synergy between PCCP, sophisticated organizational change methods, and provider level training, and to document their impact on consumer outcomes. This investigative team brings together experts in PCCP and recovery with experts in services and implementation research to generate valuable guidance for how state systems engaged in the transformation process can best use their limited resources during times of significant fiscal constraint.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New York
-
New York, New York, United States, 10003-6654
- New York University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Receiving services at participating community mental health clinics
Exclusion Criteria:
- None
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Person-Centered Care Planning
Arm will receive provider level training in Person Centered Care Planning
|
PCCP is a manualized provider-based intervention that maximizes consumer choice for adults receiving mental health services.
PCCP focuses on engagement and individualized care, thereby enhancing the impact of existing evidence based practices.
|
|
No Intervention: Treatment as Usual
Arm will receive treatment as usual in community mental health clinic
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Service Engagement
Time Frame: 12 Month
|
Consumers attending scheduled appointments at mental health clinics
|
12 Month
|
|
Service Engagement
Time Frame: 24 Month
|
Consumers attending scheduled appointments at mental health clinics
|
24 Month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Person Centered Care Competency
Time Frame: 12 Month
|
The 32-item Person Centered Care Questionnaire assesses fidelity to the PCCP intervention.
|
12 Month
|
|
Recovery Orientation
Time Frame: 12 Month
|
The Recovery Self Assessment is a 36-item measure assessing the degree to which recovery oriented practices are implemented in an agency.
|
12 Month
|
|
Person Centered Care Competency
Time Frame: 18 Month
|
The 32-item Person Centered Care Questionnaire assesses fidelity to the PCCP intervention.
|
18 Month
|
|
Recovery Orientation
Time Frame: 18 Month
|
The Recovery Self Assessment is a 36-item measure assessing the degree to which recovery oriented practices are implemented in an agency.
|
18 Month
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Victoria Stanhope, PhD, New York University
Publications and helpful links
General Publications
- Stanhope V, Matthews EB. Delivering person-centered care with an electronic health record. BMC Med Inform Decis Mak. 2019 Aug 22;19(1):168. doi: 10.1186/s12911-019-0897-6.
- Stanhope V, Tondora J, Davidson L, Choy-Brown M, Marcus SC. Person-centered care planning and service engagement: a study protocol for a randomized controlled trial. Trials. 2015 Apr 22;16:180. doi: 10.1186/s13063-015-0715-0.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PCCP-13-9762
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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