Chronic DiseasePCORI OHNCT02318797
Optimizing Behavioral Health Homes for Adults With Serious Mental Illness
A study testing Patient Self-Directed Care and Provider-Supported Integrated Care in people with Chronic Disease and Mental Health, run by University of Pittsburgh at 1 site in United States.
Trial summary
Adults with serious mental illness (SMI) frequently have unmet medical needs which place them at risk for adverse health outcomes. While there are proven ways to manage and/or prevent serious medical conditions common among this population, information is needed to understand their impact on outcomes that matter most… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Disease, Mental Health, Behavioral Health
- What is being tested?
- Patient Self-Directed Care and Provider-Supported Integrated Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,229 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2013to Jan 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Adults age 18 and older
- Serious mental illness (schizophrenia, bipolar disorder, major depression)
- Receive services at one of the 11 participating community mental health centers
- At least one claim for outpatient case management or peer specialist services
Who cannot join
- Not willing to provide informed consent
- Assessed by clinicians as being too ill to be treated on an outpatient basis
- Unable to speak, read, or understand English at the minimum required level
Trial locations and contacts
1 site in 1 country.
United States1 site
Community Care Behavioral Health Organizations
Pittsburgh, Pennsylvania, 15229
About this study
Official title: Optimizing Behavioral Health Homes by Focusing on Outcomes That Matter Most for Adults With Serious Mental Illness
Adults with serious mental illness (SMI) frequently have unmet medical needs which place them at risk for adverse health outcomes. While there are proven ways to manage and/or prevent serious medical conditions common among this population, information is needed to understand their impact on outcomes that matter most for patients, particularly in community mental health centers (CMHCs) where most adults with SMI receive their care and rural areas where locating and receiving health care services can be challenging.
The investigators will test two promising ways for promoting the health, wellness, and recovery of adults with SMI. One way will help patients manage their health and health care through self-management strategies, including the use of a web portal, and peer support (patient self-directed care) and the other through interactions with nurses during clinic visits (provider-supported integrated care).
Read more
The investigators will compare the two interventions on three primary patient-centered outcomes (i.e. patient activation in care, health status, engagement in primary/specialty care). The investigators hypothesize that:
- Patient self-directed care will result in improvement in patient activation.
- Provider-supported integrated care will result in greater improvement in frequency in primary/specialty care visits.
- Both interventions will result in significant improvements in the three primary outcomes.
The investigators will collect information from patients, caregivers, and clinic staff at different points in time during the study. Patients will be asked to complete questionnaires and additional data on their service use will be gathered. Some patients and providers will also be interviewed about their experiences with care. The investigators will examine these data to learn if, how, and why the new services improve outcomes over time. This information will help us understand patient and other stakeholder views about the services and, if appropriate, ensure their continued and/or expanded availability.
Read the detailed description
The combination of high medical need with difficulty accessing quality medical care makes adults with serious mental illness (SMI) one of our nation's most medically vulnerable populations. While evidence-based interventions exist for managing and/or preventing high rates of chronic medical conditions in this population, information is needed to understand their impact on outcomes that matter most for patients, particularly in community mental health centers (CMHCs) where most adults with SMI receive their care and rural areas where availability of and access to health care services is limited.
Building on the work of a multi-stakeholder collaboration in rural Pennsylvania, the UPMC Center for High-Value Health Care and our patient, provider, and payer partners will evaluate two promising interventions-patient self-directed care and provider-supported integrated care-for promoting the health, wellness, and recovery of adults with SMI. We will address four questions that patients have identified as important to them:
- Given my mental and physical conditions, what should I expect will happen to my overall health, wellness, and recovery when I engage in the new services offered by my CMHC?
- If I choose to participate in these services, what are the potential advantages or disadvantages to me?
- In what ways can I become more active in managing my own health and health care?
- Which of the services that my CMHC could make available to me will impact outcomes that I care about and help me make the best decisions about my health and care? Our aims compare the effectiveness of the interventions on patient-centered outcomes and explore the moderating role of patient characteristics and the mediating role of engagement in the interventions. By demonstrating which interventions improve outcomes for whom under what circumstances, we will inform positive patient heath choices and key stakeholder decision making to support these choices, thereby advancing health system improvement efforts to avoid early mortality and comorbidity in this population.
We have enrolled 1,229 Medicaid-enrolled adults who have or are at risk for chronic medical conditions and receive care at rural and suburban CMHCs. Using a cluster randomized design with a mixed-methods approach, we randomly assigned 11 CMHCs to one of the two interventions. Quantitative (self-report, claims, process) and qualitative (interviews) data will be gathered across multiple time points from baseline through the end of the two-year intervention. Descriptive and multivariate analyses will be used to examine the impact of the interventions on outcomes over time and explore the roles of moderating and mediating variables. Qualitative results will be used to understand patient and other stakeholder perspectives and promote dissemination and sustainability.
- Conditions
- Chronic Disease, Mental Health, Behavioral Health, Cardiovascular Disease, Diabetes Mellitus Type 2, Substance-related Disorders
- Being tested
- Patient Self-Directed Care, Provider-Supported Integrated Care
- Keywords
- Chronic disease, Mental Health, Behavioral Health, Community mental health centers, Intervention studies, Mixed methods, Qualitative research
- Medical subject headings
- Chronic Disease, Psychological Well-Being, Cardiovascular Diseases, Diabetes Mellitus, Type 2, Substance-Related Disorders, Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient Self-Directed CareBehavioural
Patient self-management toolkits, web portal with information on health conditions, personal health care use data, health tracking tools and wellness programs
Provider-Supported Integrated CareBehavioural
Registered nurse on staff at community mental health centers with access to patient-level physical health information to: 1) work with patients on coordinating their care, 2) enhance communication between providers and payer, and 3) provide patient wellness support and education
| Study group | Role | What they receive |
|---|---|---|
| Patient Self-Directed Care | Active comparator | See intervention description Receives: Behavioral: Patient Self-Directed Care |
| Provider-Supported Integrated Care | Active comparator | See intervention description Receives: Behavioral: Provider-Supported Integrated Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Patient Activation in Care (PAM, a 13-item Scale)
Assessed using the PAM, a 13-item scale that renders a total activation score. This measure gauges the knowledge, skills, and confidence of patients essential to managing their own health and health care. It divides into progressively higher levels of activation: starting to take a role, building knowledge and confidences, taking action, and maintaining behaviors. The raw score scale for the PAM ranges from 13 to 52. The activation scale for the PAM ranges from 0 to 100. The lower values represent a poor outcome while higher values represent a better outcome.
Measured: Baseline and every 6 months over 2 year active intervention period
Change in Health Status ( SF-12v2™): Physical Health Sub-scale
Health status is measured using the SF-12v2™, a widely used and practical health survey tool consisting of 12 questions and two sub-scales for measuring physical and mental health status and symptom effects and functioning. The physical health component summary score is created using a weighted sum of all 12 items and then a scoring algorithm places negative weights on four of the health domains and positive weights on the other four health domains. Scores range from 0-100 and better physical health is indicated by a higher score.
Measured: Baseline and every 6 months over 2 year active intervention period
Change in Engagement in Primary/Specialty Care
The frequency of primary/specialty care visits over two 12-month time periods.
Measured: Updated annually using claims data over 2 year active intervention period
Change in Health Status ( SF-12v2™): Mental Health Sub-scale
Health status is measured using the SF-12v2™, a widely used and practical health survey tool consisting of 12 questions and two sub-scales for measuring physical and mental health status and symptom effects and functioning. The mental health component summary score is created using a weighted sum of all 12 items and then a scoring algorithm places negative weights on four of the health domains and positive weights on the other four health domains (reverse of the weighting used for the physical health component summary score). Scores range from 0-100 and better mental health is indicated by a higher score.
Measured: Baseline and every 6 months during the active intervention period
Secondary outcomes (13)
Change in Hope (Hope Scale)
Assessed using the Hope Scale, an instrument designed to measure hope that has been previously used in health services research. Twelve items are rated on a four-point response scale ranging from "definitely false" to "definitely true" and summed to produce a total score. The hope scale ranges from 1 to 10, with 1 being no hope and 10 being filled with hope.
Measured: Baseline and every 6 months during the active intervention period
Change in Quality of Life (QLESQ)
Patient quality of life is measured using the QLESQ (Quality of Life Enjoyment and Satisfaction Questionnaire) in which participants respond on a scale of 1 (very poor) to 5 (very good) their level of satisfaction with a variety of social and physical domains. The total raw score ranges from 14 to 70 or 0-100%. Only the first 14 items yield the raw total score as the last two items are standalone. The raw total score is transformed into a percentage maximum possible score using the following formula: (raw total score-minimum score)/(maximum possible raw score-minimum score). The lower values/percentages represent a poor outcome while higher values/percentages represent a better outcome. The information below reflects raw scores (rather than percentages).
Measured: Baseline and every 6 months over 2 year active intervention period
Change in Medication Adherence - Diabetes
Claims data used to calculate diabetes medication possession ratio (MPO) for participants diagnosed with diabetes in 6 month time periods. If the (first_fill - last_end_Date) > 180 then MPR = (total days supply - (first_fill - last_end_Date) - 180 ) / 180. If the total duration was not greater than 180 days, MPR = total days supply / 180.
Measured: Updated annually using claims data over 2 year active intervention period
Change in Functional Status (Sheehan Disability Scale)
Functional status is measured using the Sheehan Disability Scale which assesses functional impairment in three domains including: work/school, social and family life. Respondents rate the extent to which work/school, social life and home life or family responsibilities are impaired by symptoms. The three items from the Sheehan Disability Scale are summed together into a single measure of global functional impairment. This measure ranges from 0 to 30, with 0 being unimpaired and 30 being highly impaired.
Measured: Baseline and every 6 months over 2 year active intervention period
Change in Emergent Care Use (Claims Data)
Behavioral and physical health claims data will be obtained to determine frequency of emergent service use for participants over 12-month time periods.
Measured: Updated annually using claims data over 2 year active intervention period
Change in Lab Monitoring - Overall
Frequency of lab tests (glucose, lipids, EKG) in 12 month periods
Measured: Updated annually using claims data over 2 year active intervention period
Change in Patient Satisfaction With Care
Change in patient satisfaction with care was assessed using the Patient Assessment of Care for Chronic Conditions (PACIC). Each item of the PACIC is on a 1 to 5 scale. The total score is the average of all 20 item scores. Higher scores represent increased frequency of structured chronic care.
Measured: Baseline and every 6 months over 2 year active intervention period
Change in Medication Adherence - Antipsychotics
Claims data used to calculate antipsychotic medication possession ratio (MPR) for participants in 6 month time periods. If the (first_fill - last_end_Date) > 180 then MPR = (total days supply - (first_fill - last_end_Date) - 180 ) / 180. If the total duration was not greater than 180 days, MPR = total days supply / 180.
Measured: Updated annually using claims data over 2 year active intervention period
Change in Medication Adherence - Hypertension
Claims data used to calculate antihypertensive medication possession ratio (MPR) for participants in 6 month time periods. If the (first_fill - last_end_Date) > 180 then MPR = (total days supply - (first_fill - last_end_Date) - 180 ) / 180. If the total duration was not greater than 180 days, MPR = total days supply / 180.
Measured: Updated annually using claims data over 2 year active intervention period
Change in Medication Adherence - Antidepressants
Claims data used to calculate antidepressant medication possession ratio (MPR) for participants in 6 month time periods. If the (first_fill - last_end_Date) > 180 then MPR = (total days supply - (first_fill - last_end_Date) - 180 ) / 180. If the total duration was not greater than 180 days, MPR = total days supply / 180.
Measured: Updated annually using claims data over 2 year active intervention period
Change in Lab Monitoring - Glucose
Frequency of glucose lab tests in 12 month periods
Measured: Updated annually using claims data over 2 year active intervention period
Change in Lab Monitoring - Lipids
Frequency of lipid lab tests in 12 month periods
Measured: Updated annually using claims data over 2 year active intervention period
Change in Lab Monitoring - EKG
Frequency of EKG tests in 12 month periods
Measured: Updated annually using claims data over 2 year active intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2014 (estimated)
- Study startOct 2013
- Primary completionOct 2016
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic DiseaseStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 1,229 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- UPMC Center for High-Value Health Care, Western Psychiatric Institute and Clinic of UPMC, Community Care Behavioral Health Organization, Columbia Montour Snyder Union Mental Health, Behavioral Health Alliance of Rural Pennsylvania
- Responsible party
- Principal investigator, Charles Reynolds, University of Pittsburgh
- Investigators
- Charles F. Reynolds, MD, Principal investigator, University of Pittsburgh; UPMC Center for High-Value Health CareJames M. Schuster, MD, MBA, Principal investigator, Community Care Behavioral Health; UPMC Center for High-Value Health CareTracy A. Carney, AAS, Principal investigator, Recovery Central Clubhouse, Columbia Montour Snyder Union Mental Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02318797
- Sponsor's protocol ID
- PCORI 271
- Acronym
- PCORI OH
- Status last verified
- Feb 2018
- First submitted
- 25 Nov 2014
- Last updated
- 22 Feb 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided: Still determining data sharing plan
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Behavioral Health Homes by Focusing on Outcomes That Matter Most for Adults With Serious Mental Illness
- ClinicalTrials.gov ID
- NCT02318797
- Acronym / sponsor ID
- PCORI OH / PCORI 271
- Conditions
- Chronic Disease, Mental Health, Behavioral Health, Cardiovascular Disease, Diabetes Mellitus Type 2, Substance-related Disorders
- Keywords
- Chronic disease, Mental Health, Behavioral Health, Community mental health centers, Intervention studies, Mixed methods, Qualitative research
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,229 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- UPMC Center for High-Value Health Care, Western Psychiatric Institute and Clinic of UPMC, Community Care Behavioral Health Organization, Columbia Montour Snyder Union Mental Health, Behavioral Health Alliance of Rural Pennsylvania
- Study start
- Oct 2013
- Primary completion
- Oct 2016 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 17 Dec 2014 (estimated)
- Results
- Posted 22 Feb 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Adults with serious mental illness (SMI) frequently have unmet medical needs which place them at risk for adverse health outcomes. While there are proven ways to manage and/or prevent serious medical conditions common among this population, information is needed to understand their impact on outcomes that matter most for patients, particularly in community mental health centers (CMHCs) where most adults with SMI receive their care and rural areas where locating and receiving health care services can be challenging.
The investigators will test two promising ways for promoting the health, wellness, and recovery of adults with SMI. One way will help patients manage their health and health care through self-management strategies, including the use of a web portal, and peer support (patient self-directed care) and the other through interactions with nurses during clinic visits (provider-supported integrated care).
The investigators will compare the two interventions on three primary patient-centered outcomes (i.e. patient activation in care, health status, engagement in primary/specialty care). The investigators hypothesize that:
- Patient self-directed care will result in improvement in patient activation.
- Provider-supported integrated care will result in greater improvement in frequency in primary/specialty care visits.
- Both interventions will result in significant improvements in the three primary outcomes.
The investigators will collect information from patients, caregivers, and clinic staff at different points in time during the study. Patients will be asked to complete questionnaires and additional data on their service use will be gathered. Some patients and providers will also be interviewed about their experiences with care. The investigators will examine these data to learn if, how, and why the new services improve outcomes over time. This information will help us understand patient and other stakeholder views about the services and, if appropriate, ensure their continued and/or expanded availability.
Detailed description
The combination of high medical need with difficulty accessing quality medical care makes adults with serious mental illness (SMI) one of our nation's most medically vulnerable populations. While evidence-based interventions exist for managing and/or preventing high rates of chronic medical conditions in this population, information is needed to understand their impact on outcomes that matter most for patients, particularly in community mental health centers (CMHCs) where most adults with SMI receive their care and rural areas where availability of and access to health care services is limited.
Building on the work of a multi-stakeholder collaboration in rural Pennsylvania, the UPMC Center for High-Value Health Care and our patient, provider, and payer partners will evaluate two promising interventions-patient self-directed care and provider-supported integrated care-for promoting the health, wellness, and recovery of adults with SMI. We will address four questions that patients have identified as important to them:
- Given my mental and physical conditions, what should I expect will happen to my overall health, wellness, and recovery when I engage in the new services offered by my CMHC?
- If I choose to participate in these services, what are the potential advantages or disadvantages to me?
- In what ways can I become more active in managing my own health and health care?
- Which of the services that my CMHC could make available to me will impact outcomes that I care about and help me make the best decisions about my health and care? Our aims compare the effectiveness of the interventions on patient-centered outcomes and explore the moderating role of patient characteristics and the mediating role of engagement in the interventions. By demonstrating which interventions improve outcomes for whom under what circumstances, we will inform positive patient heath choices and key stakeholder decision making to support these choices, thereby advancing health system improvement efforts to avoid early mortality and comorbidity in this population.
We have enrolled 1,229 Medicaid-enrolled adults who have or are at risk for chronic medical conditions and receive care at rural and suburban CMHCs. Using a cluster randomized design with a mixed-methods approach, we randomly assigned 11 CMHCs to one of the two interventions. Quantitative (self-report, claims, process) and qualitative (interviews) data will be gathered across multiple time points from baseline through the end of the two-year intervention. Descriptive and multivariate analyses will be used to examine the impact of the interventions on outcomes over time and explore the roles of moderating and mediating variables. Qualitative results will be used to understand patient and other stakeholder perspectives and promote dissemination and sustainability.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient Self-Directed Care | Active comparator | Behavioral: Patient Self-Directed CareSee intervention description |
| Provider-Supported Integrated Care | Active comparator | Behavioral: Provider-Supported Integrated CareSee intervention description |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults age 18 and older
- Serious mental illness (schizophrenia, bipolar disorder, major depression)
- Receive services at one of the 11 participating community mental health centers
- At least one claim for outpatient case management or peer specialist services
Key exclusion criteria (3 listed)
- Not willing to provide informed consent
- Assessed by clinicians as being too ill to be treated on an outpatient basis
- Unable to speak, read, or understand English at the minimum required level
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 |
|---|---|---|
| Patient Self-Directed CarePatient self-management toolkits, web portal with information on health conditions, personal health care use data, health tracking tools and wellness programs | Behavioural | Patient Self-Directed Care |
| Provider-Supported Integrated CareRegistered nurse on staff at community mental health centers with access to patient-level physical health information to: 1) work with patients on coordinating their care, 2) enhance communication between providers and payer, and 3) provide patient wellness support and education | Behavioural | Provider-Supported Integrated Care |
Primary outcome
Change in Patient Activation in Care (PAM, a 13-item Scale)
Time frame: Baseline and every 6 months over 2 year active intervention period
Assessed using the PAM, a 13-item scale that renders a total activation score. This measure gauges the knowledge, skills, and confidence of patients essential to managing their own health and health care. It divides into progressively higher levels of activation: starting to take a role, building knowledge and confidences, taking action, and maintaining behaviors. The raw score scale for the PAM ranges from 13 to 52. The activation scale for the PAM ranges from 0 to 100. The lower values represent a poor outcome while higher values represent a better outcome.
Change in Health Status ( SF-12v2™): Physical Health Sub-scale
Time frame: Baseline and every 6 months over 2 year active intervention period
Health status is measured using the SF-12v2™, a widely used and practical health survey tool consisting of 12 questions and two sub-scales for measuring physical and mental health status and symptom effects and functioning. The physical health component summary score is created using a weighted sum of all 12 items and then a scoring algorithm places negative weights on four of the health domains and positive weights on the other four health domains. Scores range from 0-100 and better physical health is indicated by a higher score.
Change in Engagement in Primary/Specialty Care
Time frame: Updated annually using claims data over 2 year active intervention period
The frequency of primary/specialty care visits over two 12-month time periods.
Change in Health Status ( SF-12v2™): Mental Health Sub-scale
Time frame: Baseline and every 6 months during the active intervention period
Health status is measured using the SF-12v2™, a widely used and practical health survey tool consisting of 12 questions and two sub-scales for measuring physical and mental health status and symptom effects and functioning. The mental health component summary score is created using a weighted sum of all 12 items and then a scoring algorithm places negative weights on four of the health domains and positive weights on the other four health domains (reverse of the weighting used for the physical health component summary score). Scores range from 0-100 and better mental health is indicated by a higher score.
13 secondary outcomes
Change in Hope (Hope Scale)
Time frame: Baseline and every 6 months during the active intervention period
Change in Quality of Life (QLESQ)
Time frame: Baseline and every 6 months over 2 year active intervention period
Change in Medication Adherence - Diabetes
Time frame: Updated annually using claims data over 2 year active intervention period
Change in Functional Status (Sheehan Disability Scale)
Time frame: Baseline and every 6 months over 2 year active intervention period
Change in Emergent Care Use (Claims Data)
Time frame: Updated annually using claims data over 2 year active intervention period
Change in Lab Monitoring - Overall
Time frame: Updated annually using claims data over 2 year active intervention period
Change in Patient Satisfaction With Care
Time frame: Baseline and every 6 months over 2 year active intervention period
Change in Medication Adherence - Antipsychotics
Time frame: Updated annually using claims data over 2 year active intervention period
Change in Medication Adherence - Hypertension
Time frame: Updated annually using claims data over 2 year active intervention period
Change in Medication Adherence - Antidepressants
Time frame: Updated annually using claims data over 2 year active intervention period
Change in Lab Monitoring - Glucose
Time frame: Updated annually using claims data over 2 year active intervention period
Change in Lab Monitoring - Lipids
Time frame: Updated annually using claims data over 2 year active intervention period
Change in Lab Monitoring - EKG
Time frame: Updated annually using claims data over 2 year active intervention period
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided. Still determining data sharing plan
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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.
Charles F. Reynolds, MD principal investigator
University of Pittsburgh; UPMC Center for High-Value Health Care
James M. Schuster, MD, MBA principal investigator
Community Care Behavioral Health; UPMC Center for High-Value Health Care
Tracy A. Carney, AAS principal investigator
Recovery Central Clubhouse, Columbia Montour Snyder Union Mental Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient Self-Directed Care and Provider-Supported Integrated Care in people with Chronic Disease and Mental Health, run by University of Pittsburgh 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 4 inclusion and 3 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 22 Feb 2018. 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?
Yes. Results are posted in the registry (first posted 22 Feb 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Patient Activation in Care (PAM, a 13-item Scale) (time frame: Baseline and every 6 months over 2 year active intervention period). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Feb 2018.