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.
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.
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:
- 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.
- Conditions
- Severe Mental Illness
- 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 group | Role | What they receive |
|---|---|---|
| Person-Centered Care Planning | Experimental | Arm will receive provider level training in Person Centered Care Planning Receives: Other: Person Centered Care Planning |
| Treatment as Usual | No intervention | Arm 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.
Service Engagement
Consumers attending scheduled appointments at mental health clinics
Measured: 12 Month
Service Engagement
Consumers attending scheduled appointments at mental health clinics
Measured: 24 Month
Secondary outcomes (4)
Person Centered Care Competency
The 32-item Person Centered Care Questionnaire assesses fidelity to the PCCP intervention.
Measured: 12 Month
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
Person Centered Care Competency
The 32-item Person Centered Care Questionnaire assesses fidelity to the PCCP intervention.
Measured: 18 Month
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.
- First posted24 Nov 2014 (estimated)
- Study start1 Sep 2013
- Primary completion1 Feb 2019
- Study completion1 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Severe Mental IllnessStudies of the same condition, open and under way.
- More trials run by New York UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- New York University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pennsylvania, Yale University
- Responsible party
- Sponsor
- Investigators
- Victoria Stanhope, PhD, Principal investigator, New York University
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 31438960Stanhope 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
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Person-Centered Care Planning and Service Engagement
- ClinicalTrials.gov ID
- NCT02299492
- Acronym / sponsor ID
- PCCP / PCCP-13-9762
- Conditions
- Severe Mental Illness
- Keywords
- Mental Health Services
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 570 participants (actual)
- Lead sponsor
- New York UniversityUniversity, hospital or other
- Collaborators
- University of Pennsylvania, Yale University
- Study start
- 1 Sep 2013
- Primary completion
- 1 Feb 2019 (actual)
- Study completion
- 1 Dec 2019 (actual)
- First posted
- 24 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Person-Centered Care Planning | Experimental | Other: Person Centered Care PlanningArm will receive provider level training in Person Centered Care Planning |
| Treatment as Usual | No intervention | –Arm will receive treatment as usual in community mental health clinic |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Receiving services at participating community mental health clinics
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Person Centered Care PlanningPCCP 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. | Other | Person-Centered Care Planning |
Primary outcome
Service Engagement
Time frame: 12 Month
Consumers attending scheduled appointments at mental health clinics
Service Engagement
Time frame: 24 Month
Consumers attending scheduled appointments at mental health clinics
4 secondary outcomes
Person Centered Care Competency
Time frame: 12 Month
Recovery Orientation
Time frame: 12 Month
Person Centered Care Competency
Time frame: 18 Month
Recovery Orientation
Time frame: 18 Month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2022.
- Derived from this study: PubMed 31438960Stanhope 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.
- Derived from this study: PubMed 25897762Stanhope 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Victoria Stanhope, PhD principal investigator
New York University
1 site in 1 country: see every site and its status.
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.