Schizophrenia Spectrum & Other Psychotic DisordersSMI-PACTNCT01668355
PACT for Individuals With Serious Mental Illness
A study testing Patient Aligned Care Team (PACT) in people with Schizophrenia Spectrum & Other Psychotic Disorders, run by VA Office of Research and Development at 3 sites in United States.
Trial summary
People with serious mental illness have difficulty making good use of primary care, and die, on average, years earlier than others in the population. The greatest contributors to this premature mortality are medical illnesses, especially cardiovascular disease and cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Schizophrenia Spectrum & Other Psychotic Disorders
- What is being tested?
- Patient Aligned Care Team (PACT)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 331 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Sep 2015to 6 Feb 2019
- 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
- Patient subjects:
- currently enrolled at one of the 3 participating VA healthcare centers
- Veteran
- diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder, chronic severe PTSD, or recurrent major depression with psychosis
- Milestone of Recovery Scale (MORS) score is 6 or above (indicates recovery status is coping rehabilitating or better)
- Staff subjects:
- employed at one of the 3 participating VA healthcare centers
- member of PACT, member of SMI PACT, member of primary care mental health integration, provider at mental health clinic, administrator overseeing mental health, or administrator overseeing primary care
Who cannot join
- none
Trial locations and contacts
3 sites in 1 country.
United States3 sites
VA Southern Nevada Healthcare System, North Las Vegas, NV
Las Vegas, Nevada, 89106
VA San Diego Healthcare System, San Diego, CA
San Diego, California, 92161
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
West Los Angeles, California, 90073
About this study
Official title: PACT to Improve Health Care in People With Serious Mental Illness (SMI-PACT)
People with serious mental illness have difficulty making good use of primary care, and die, on average, years earlier than others in the population. The greatest contributors to this premature mortality are medical illnesses, especially cardiovascular disease and cancer. The Patient Centered Medical Home is a model for reorganizing primary care practice so that healthcare is more effective, efficient, and user-friendly. It has been implemented across VA as the, "Patient Aligned Care Team" (PACT). It is unclear, however, how this PACT model applies to people whose predominant illness is treated by specialists. This is the case for people with serious mental illness (SMI), many of whom receive ongoing treatment at mental health clinics. To achieve optimal health outcomes in the population with SMI, it may be necessary to adapt the PACT model so that it includes approaches that have proven to improve healthcare in this population. This project implements an adapted "SMI-PACT" model, and evaluates its effect on Veterans with SMI.
Read the detailed description
Background/Rationale:
People with serious mental illness (SMI) die, on average, many years prematurely, with rates of premature mortality 2 to 3 times greater than the general population. Over 60% of premature deaths in this population are due to "natural causes," especially poorly treated cardiovascular, respiratory, and infectious diseases. Although the VA is a centrally organized, comprehensive healthcare system, Veterans with SMI still have difficulty navigating the system, and are at substantially elevated risk for premature death. Too often, they do not attend scheduled appointments or fail to engage in primary care treatment, and consequently do not get valuable preventive and primary care services.
Primary care in VA has undergone significant transformation under the Patent Aligned Care Team (PACT) model, which is based on the Patient Centered Medical Home (PCMH) concept. PACT has the goal of improving the quality, efficiency, and patient-centeredness of primary care. But it remains unclear how PACT will impact the large populations of Veterans whose predominant illness is treated in specialty settings, such as people with SMI. Research can inform efforts to apply the PACT model. For example, while people with SMI do poorly with usual primary care arrangements, there is substantial evidence that integrated care and medical care management approaches can improve medical treatment and outcomes, and reduce treatment costs, in people with SMI.
Objective:
Using available evidence, the investigators propose to implement and evaluate a specialized PACT model that meets the needs of individuals with SMI ("SMI-PACT").
Methods:
This project will partner with leadership to implement SMI-PACT, with the goal of improving healthcare and outcomes among people with SMI, while reducing unnecessary use of emergency and hospital services. Evidence-based quality improvement strategies will be used to reorganize processes of care. In a site-level controlled trial, this project will evaluate the effect, relative to usual care, of SMI-PACT implementation on (a) provision of appropriate preventive and medical treatments; (b) patient health-related quality of life and satisfaction with care; and (c) medical and mental health treatment utilization and costs. The project includes a mixed methods formative evaluation of usual care and SMI-PACT implementation to strengthen the intervention, and assess barriers and facilitators to its implementation. Mixed methods will also be used to investigate the relationships between organizational context, intervention factors, and patient and provider outcomes; and identify patient factors related to successful patient outcomes.
Significance:
This project's approach to SMI-PACT is consistent with the VA PACT model, and with efforts in VA to improve care for Veterans with psychiatric disorders. This will be one of the first projects to systematically implement and evaluate the PCMH and PACT concepts for patients with serious mental illness. Should SMI-PACT be demonstrated to be feasible and effective, the model could be used more broadly to improve the quality and efficiency of care for Veterans.
- Being tested
- Patient Aligned Care Team (PACT)
- Keywords
- Delivery of Healthcare, Health Services Research, Integrated Healthcare Systems, Healthcare Quality, Access, and Evaluation, Primary Care, Quality Improvement, Psychotic Disorders, Medical Home, Psychiatry, Patient Care Management, Nursing Care Management, Treatment Costs
- Medical subject headings
- Schizophrenia Spectrum and Other Psychotic Disorders, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient Aligned Care Team (PACT)Other
Also called SMI-PACT
An integrated healthcare model to coordinate and address physical health needs of people with serious mental illness. This specialized PACT medical home model is designed for individuals with serious mental illness.
| Study group | Role | What they receive |
|---|---|---|
| SMI-PACT | Experimental | Patient Aligned Care Team (PACT) medical home model to address the physical healthcare needs of individuals with serious mental illness Receives: Other: Patient Aligned Care Team (PACT) |
| Usual Care | No intervention | Usual Primary Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Provision of Appropriate Preventive and Medical Treatments
Screened for body mass index, blood pressure, lipids, and glucose or hemoglobin A1c.
Measured: 15 months
Patient Health-related Quality of Life: Veterans RAND 6 Item Health Survey (VR-6) Physical Health
Physical health related quality of life. The scale range is 0 to 100. Higher scores mean a better outcome.
Measured: 15 months
Patient Health-related Quality of Life: Veterans RAND 6 Item Health Survey (VR-6) Mental Health
Mental health related quality of life. The scale range is 0 to 100. Higher scores mean a better outcome.
Measured: 15 months
Patient Satisfaction With Care: Ambulatory Care Experiences Survey (ACES; Short Form)
Evaluates patients' experiences and satisfaction with a physician's practice. The ACES uses the Institute of Medicine definition of primary care as its underlying conceptual model for measurement. The ACES range is 0 to 100. Higher scores mean a better outcome.
Measured: 15 months
Patient Satisfaction With Care: Patient Assessment of Chronic Illness Care (ACIC/PACIC)
Assesses the patient's experience and satisfaction with receipt of chronic care. This measure aligns with the Chronic Care Model. The ACIC/PACIC ranges from from 1 to 5. Higher scores mean a better outcome.
Measured: 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2012 (estimated)
- Study start1 Sep 2015
- Primary completion6 Feb 2019
- Study completion6 Feb 2019
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.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Schizophrenia Spectrum & Other Psychotic DisordersStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- medical home tailored for people with serious mental illness
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 331 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Alexander S Young, MD MSHS, Principal investigator, VA Greater Los Angeles Healthcare System, West Los Angeles, CA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01668355
- Sponsor's protocol ID
- SDP 12-177
- Acronym
- SMI-PACT
- Status last verified
- Feb 2020
- First submitted
- 7 Aug 2012
- Last updated
- 28 Feb 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Young AS, Cohen AN, Chang ET, Flynn AWP, Hamilton AB, Oberman R, Vinzon M. A clustered controlled trial of the implementation and effectiveness of a medical home to improve health care of people with serious mental illness: study protocol. BMC Health Serv Res. 2018 Jun 7;18(1):428. doi: 10.1186/s12913-018-3237-0.
PubMed 29880047Young AS, Chang ET, Cohen AN, Oberman R, Chang DT, Hamilton AB, Lindamer LA, Sanford J, Whelan F. The Effectiveness of a Specialized Primary Care Medical Home for Patients with Serious Mental Illness. J Gen Intern Med. 2022 Oct;37(13):3258-3265. doi: 10.1007/s11606-021-07270-x. Epub 2022 Apr 5.
PubMed 35380346
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PACT to Improve Health Care in People With Serious Mental Illness (SMI-PACT)
- ClinicalTrials.gov ID
- NCT01668355
- Acronym / sponsor ID
- SMI-PACT / SDP 12-177
- Keywords
- Delivery of Healthcare, Health Services Research, Integrated Healthcare Systems, Healthcare Quality, Access, and Evaluation, Primary Care, Quality Improvement, Psychotic Disorders, Medical Home
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 331 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Sep 2015 (actual)
- Primary completion
- 6 Feb 2019 (actual)
- Study completion
- 6 Feb 2019 (actual)
- First posted
- 20 Aug 2012 (estimated)
- Results
- Posted 28 Feb 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
People with serious mental illness have difficulty making good use of primary care, and die, on average, years earlier than others in the population. The greatest contributors to this premature mortality are medical illnesses, especially cardiovascular disease and cancer. The Patient Centered Medical Home is a model for reorganizing primary care practice so that healthcare is more effective, efficient, and user-friendly. It has been implemented across VA as the, "Patient Aligned Care Team" (PACT). It is unclear, however, how this PACT model applies to people whose predominant illness is treated by specialists. This is the case for people with serious mental illness (SMI), many of whom receive ongoing treatment at mental health clinics. To achieve optimal health outcomes in the population with SMI, it may be necessary to adapt the PACT model so that it includes approaches that have proven to improve healthcare in this population. This project implements an adapted "SMI-PACT" model, and evaluates its effect on Veterans with SMI.
Detailed description
Background/Rationale:
People with serious mental illness (SMI) die, on average, many years prematurely, with rates of premature mortality 2 to 3 times greater than the general population. Over 60% of premature deaths in this population are due to "natural causes," especially poorly treated cardiovascular, respiratory, and infectious diseases. Although the VA is a centrally organized, comprehensive healthcare system, Veterans with SMI still have difficulty navigating the system, and are at substantially elevated risk for premature death. Too often, they do not attend scheduled appointments or fail to engage in primary care treatment, and consequently do not get valuable preventive and primary care services.
Primary care in VA has undergone significant transformation under the Patent Aligned Care Team (PACT) model, which is based on the Patient Centered Medical Home (PCMH) concept. PACT has the goal of improving the quality, efficiency, and patient-centeredness of primary care. But it remains unclear how PACT will impact the large populations of Veterans whose predominant illness is treated in specialty settings, such as people with SMI. Research can inform efforts to apply the PACT model. For example, while people with SMI do poorly with usual primary care arrangements, there is substantial evidence that integrated care and medical care management approaches can improve medical treatment and outcomes, and reduce treatment costs, in people with SMI.
Objective:
Using available evidence, the investigators propose to implement and evaluate a specialized PACT model that meets the needs of individuals with SMI ("SMI-PACT").
Methods:
This project will partner with leadership to implement SMI-PACT, with the goal of improving healthcare and outcomes among people with SMI, while reducing unnecessary use of emergency and hospital services. Evidence-based quality improvement strategies will be used to reorganize processes of care. In a site-level controlled trial, this project will evaluate the effect, relative to usual care, of SMI-PACT implementation on (a) provision of appropriate preventive and medical treatments; (b) patient health-related quality of life and satisfaction with care; and (c) medical and mental health treatment utilization and costs. The project includes a mixed methods formative evaluation of usual care and SMI-PACT implementation to strengthen the intervention, and assess barriers and facilitators to its implementation. Mixed methods will also be used to investigate the relationships between organizational context, intervention factors, and patient and provider outcomes; and identify patient factors related to successful patient outcomes.
Significance:
This project's approach to SMI-PACT is consistent with the VA PACT model, and with efforts in VA to improve care for Veterans with psychiatric disorders. This will be one of the first projects to systematically implement and evaluate the PCMH and PACT concepts for patients with serious mental illness. Should SMI-PACT be demonstrated to be feasible and effective, the model could be used more broadly to improve the quality and efficiency of care for Veterans.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- medical home tailored for people with serious mental illness
| Arm | Type | Receives |
|---|---|---|
| SMI-PACT | Experimental | Other: Patient Aligned Care Team (PACT)Patient Aligned Care Team (PACT) medical home model to address the physical healthcare needs of individuals with serious mental illness |
| Usual Care | No intervention | –Usual Primary Care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- currently enrolled at one of the 3 participating VA healthcare centers
- Veteran
- diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder, chronic severe PTSD, or recurrent major depression with psychosis
- Milestone of Recovery Scale (MORS) score is 6 or above (indicates recovery status is coping rehabilitating or better)
- employed at one of the 3 participating VA healthcare centers
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 |
|---|---|---|
| Patient Aligned Care Team (PACT)Also: SMI-PACTAn integrated healthcare model to coordinate and address physical health needs of people with serious mental illness. This specialized PACT medical home model is designed for individuals with serious mental illness. | Other | SMI-PACT |
Primary outcome
Provision of Appropriate Preventive and Medical Treatments
Time frame: 15 months
Screened for body mass index, blood pressure, lipids, and glucose or hemoglobin A1c.
Patient Health-related Quality of Life: Veterans RAND 6 Item Health Survey (VR-6) Physical Health
Time frame: 15 months
Physical health related quality of life. The scale range is 0 to 100. Higher scores mean a better outcome.
Patient Health-related Quality of Life: Veterans RAND 6 Item Health Survey (VR-6) Mental Health
Time frame: 15 months
Mental health related quality of life. The scale range is 0 to 100. Higher scores mean a better outcome.
Patient Satisfaction With Care: Ambulatory Care Experiences Survey (ACES; Short Form)
Time frame: 15 months
Evaluates patients' experiences and satisfaction with a physician's practice. The ACES uses the Institute of Medicine definition of primary care as its underlying conceptual model for measurement. The ACES range is 0 to 100. Higher scores mean a better outcome.
Patient Satisfaction With Care: Patient Assessment of Chronic Illness Care (ACIC/PACIC)
Time frame: 15 months
Assesses the patient's experience and satisfaction with receipt of chronic care. This measure aligns with the Chronic Care Model. The ACIC/PACIC ranges from from 1 to 5. Higher scores mean a better outcome.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 29880047Young AS, Cohen AN, Chang ET, Flynn AWP, Hamilton AB, Oberman R, Vinzon M. A clustered controlled trial of the implementation and effectiveness of a medical home to improve health care of people with serious mental illness: study protocol. BMC Health Serv Res. 2018 Jun 7;18(1):428. doi: 10.1186/s12913-018-3237-0.
- Derived from this study: PubMed 35380346Young AS, Chang ET, Cohen AN, Oberman R, Chang DT, Hamilton AB, Lindamer LA, Sanford J, Whelan F. The Effectiveness of a Specialized Primary Care Medical Home for Patients with Serious Mental Illness. J Gen Intern Med. 2022 Oct;37(13):3258-3265. doi: 10.1007/s11606-021-07270-x. Epub 2022 Apr 5.
- Individual participant dataSharing planned: No
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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.
Alexander S Young, MD MSHS principal investigator
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient Aligned Care Team (PACT) in people with Schizophrenia Spectrum & Other Psychotic Disorders, run by VA Office of Research and Development at 3 sites 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 8 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 28 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 28 Feb 2020). 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?
Provision of Appropriate Preventive and Medical Treatments (time frame: 15 months). The study lists 5 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 NCT01668355, 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 28 Feb 2020.