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Severe Mental IllnessPCCPNCT02299492

Person-Centered Care Planning and Service Engagement

A study testing Person Centered Care Planning in people with Severe Mental Illness, run by New York University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This proposed study addresses the problem of service disengagement within the mental health system. No matter how effective mental health practices are now or become in the future, they are of little value should persons with mental illnesses continue to choose not to receive them. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Severe Mental Illness
What is being tested?
Person Centered Care Planning
Could I receive a placebo?
No, everyone receives an active treatment
How many people
570 participants
Where
1 siteUnited States
Study dates
1 Sep 2013to 1 Dec 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Receiving services at participating community mental health clinics

Who cannot join

  • None

Trial locations and contacts

1 site in 1 country.

United States1 site
  • New York University

    New York, New York, 10003-6654

Other trials in United States

About this study

This proposed study addresses the problem of service disengagement within the mental health system. No matter how effective mental health practices 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. Person-centered care planning 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. The proposed study tests the effectiveness of Person-Centered Care Planning (PCCP) designed to target barriers and efficiently implement PCCP throughout an agency. By conducting a randomized controlled trial with 14 community mental health clinics from two states, the study will assess whether PCCP improves service engagement and consumer outcomes. The study will also utilize 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 study focuses on two priorities identified by the NIMH Diversion of Services and Intervention Research: developing models and methods to implement effective mental health services in the community and the study of personalized mental health care.

Read the 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:

  1. 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.
  2. Assess the effect of organizational factors on the implementation and effectiveness of PCCP
  3. 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.

Being tested
Person Centered Care Planning
Keywords
Mental Health Services
Medical subject headings
Mental Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Person Centered Care PlanningOther

    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.

Study groups in NCT02299492
Study groupRoleWhat they receive
Person-Centered Care PlanningExperimentalArm will receive provider level training in Person Centered Care Planning
Receives: Other: Person Centered Care Planning
Treatment as UsualNo interventionArm will receive treatment as usual in community mental health clinic

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Service Engagement

    Consumers attending scheduled appointments at mental health clinics

    Measured: 12 Month

  2. Service Engagement

    Consumers attending scheduled appointments at mental health clinics

    Measured: 24 Month

Secondary outcomes (4)
  1. Person Centered Care Competency

    The 32-item Person Centered Care Questionnaire assesses fidelity to the PCCP intervention.

    Measured: 12 Month

  2. Recovery Orientation

    The Recovery Self Assessment is a 36-item measure assessing the degree to which recovery oriented practices are implemented in an agency.

    Measured: 12 Month

  3. Person Centered Care Competency

    The 32-item Person Centered Care Questionnaire assesses fidelity to the PCCP intervention.

    Measured: 18 Month

  4. Recovery Orientation

    The Recovery Self Assessment is a 36-item measure assessing the degree to which recovery oriented practices are implemented in an agency.

    Measured: 18 Month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Nov 2014 (estimated)
  2. Study start1 Sep 2013
  3. Primary completion1 Feb 2019
  4. Study completion1 Dec 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
570 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02299492
Sponsor's protocol ID
PCCP-13-9762
Acronym
PCCP
Status last verified
Sep 2020
First submitted
13 Nov 2014
Last updated
1 Nov 2022
Results posted
No
Data monitoring committee
No

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.

    PubMed 31438960
  • 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.

    PubMed 25897762

Questions about this trial

What is this clinical trial studying?

A study testing Person Centered Care Planning in people with Severe Mental Illness, run by New York University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Service Engagement (time frame: 12 Month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02299492, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2022.

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