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PACT for Individuals With Serious Mental Illness

PACT to Improve Health Care in People With Serious Mental Illness (SMI-PACT)

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01668355
Acronym
SMI-PACT
Enrollment
331
Registered
2012-08-20
Start date
2015-09-01
Completion date
2019-02-06
Last updated
2020-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia Spectrum & Other Psychotic Disorders

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

Brief 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. 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.

Interventions

OTHERPatient Aligned Care Team (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.

Sponsors

VA Office of Research and Development
Lead SponsorFED

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Intervention model description

medical home tailored for people with serious mental illness

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* none

Design outcomes

Primary

MeasureTime frameDescription
Patient Satisfaction With Care: Patient Assessment of Chronic Illness Care (ACIC/PACIC)15 monthsAssesses 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.
Patient Health-related Quality of Life: Veterans RAND 6 Item Health Survey (VR-6) Physical Health15 monthsPhysical 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 Health15 monthsMental 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)15 monthsEvaluates 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.
Provision of Appropriate Preventive and Medical Treatments15 monthsScreened for body mass index, blood pressure, lipids, and glucose or hemoglobin A1c.

Other

MeasureTime frameDescription
Patient Psychopathology: Behavior and Symptom Identification Scale (BASIS-R) Depression Daily Functioning15 monthsAssesses patient psychopathology in the domain of depression/daily functioning. Scores range from 0 to 4. Higher scores mean a worse outcome.
Patient Psychopathology: Behavior and Symptom Identification Scale (BASIS-R) Interpersonal Functioning15 monthsAssesses patient psychopathology in the domain of interpersonal functioning. Scores range from 0 to 4. Lower scores mean a worse outcome.
Patient Psychopathology: Behavior and Symptom Identification Scale (BASIS-R) Psychosis15 monthsAssesses patient psychopathology in the domain of psychosis. Scores range from 0 to 4. Higher scores mean a worse outcome.

Countries

United States

Participant flow

Participants by arm

ArmCount
SMI-PACT
Patient Aligned Care Team (PACT) medical home model to address the physical healthcare needs for individuals with serious mental illness (SMI). An integrated healthcare model to coordinate and address physical health needs.
164
Usual Care
Usual Primary Care
167
Total331

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyDeath31
Overall StudyWithdrawal by Subject61

Baseline characteristics

CharacteristicUsual CareTotalSMI-PACT
Age, Continuous54.5 years
STANDARD_DEVIATION 13.9
56.6 years
STANDARD_DEVIATION 12.4
58.7 years
STANDARD_DEVIATION 10.4
Ethnicity (NIH/OMB)
Hispanic or Latino
19 Participants41 Participants22 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
127 Participants265 Participants138 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
21 Participants25 Participants4 Participants
Race (NIH/OMB)
American Indian or Alaska Native
3 Participants3 Participants0 Participants
Race (NIH/OMB)
Asian
7 Participants10 Participants3 Participants
Race (NIH/OMB)
Black or African American
37 Participants111 Participants74 Participants
Race (NIH/OMB)
More than one race
11 Participants19 Participants8 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
1 Participants2 Participants1 Participants
Race (NIH/OMB)
Unknown or Not Reported
14 Participants33 Participants19 Participants
Race (NIH/OMB)
White
94 Participants153 Participants59 Participants
Sex: Female, Male
Female
31 Participants45 Participants14 Participants
Sex: Female, Male
Male
136 Participants286 Participants150 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
3 / 1641 / 167
other
Total, other adverse events
0 / 1640 / 167
serious
Total, serious adverse events
0 / 1640 / 167

Outcome results

Primary

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.

Time frame: 15 months

Population: These are the number of subjects for whom data was available for this measure during the relevant time frame.

ArmMeasureValue (MEAN)Dispersion
SMI-PACTPatient Health-related Quality of Life: Veterans RAND 6 Item Health Survey (VR-6) Mental Health42.3 score on a scaleStandard Deviation 12.3
Usual CarePatient Health-related Quality of Life: Veterans RAND 6 Item Health Survey (VR-6) Mental Health37.6 score on a scaleStandard Deviation 12.8
Primary

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.

Time frame: 15 months

Population: These are the number of subjects for whom data was available for this measure during the relevant time frame.

ArmMeasureValue (MEAN)Dispersion
SMI-PACTPatient Health-related Quality of Life: Veterans RAND 6 Item Health Survey (VR-6) Physical Health38.9 score on a scaleStandard Deviation 11
Usual CarePatient Health-related Quality of Life: Veterans RAND 6 Item Health Survey (VR-6) Physical Health37.2 score on a scaleStandard Deviation 11.6
Primary

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.

Time frame: 15 months

Population: These are the number of subjects for whom data was available for this measure during the relevant time frame.

ArmMeasureValue (MEAN)Dispersion
SMI-PACTPatient Satisfaction With Care: Ambulatory Care Experiences Survey (ACES; Short Form)68 score on a scaleStandard Deviation 24.2
Usual CarePatient Satisfaction With Care: Ambulatory Care Experiences Survey (ACES; Short Form)66.7 score on a scaleStandard Deviation 25.1
Primary

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.

Time frame: 15 months

Population: These are the number of subjects for whom data was available for this measure during the relevant time frame.

ArmMeasureValue (MEAN)Dispersion
SMI-PACTPatient Satisfaction With Care: Patient Assessment of Chronic Illness Care (ACIC/PACIC)2.7 score on a scaleStandard Deviation 1
Usual CarePatient Satisfaction With Care: Patient Assessment of Chronic Illness Care (ACIC/PACIC)2.9 score on a scaleStandard Deviation 1
Primary

Provision of Appropriate Preventive and Medical Treatments

Screened for body mass index, blood pressure, lipids, and glucose or hemoglobin A1c.

Time frame: 15 months

Population: These are the number of subjects for whom data was available for this measure during the relevant time frame.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
SMI-PACTProvision of Appropriate Preventive and Medical TreatmentsScreened for Glucose or Hemoglobin A1c119 Participants
SMI-PACTProvision of Appropriate Preventive and Medical TreatmentsScreened for Blood Pressure146 Participants
SMI-PACTProvision of Appropriate Preventive and Medical TreatmentsScreened for Lipids88 Participants
SMI-PACTProvision of Appropriate Preventive and Medical TreatmentsScreened for Body Mass Index144 Participants
Usual CareProvision of Appropriate Preventive and Medical TreatmentsScreened for Glucose or Hemoglobin A1c85 Participants
Usual CareProvision of Appropriate Preventive and Medical TreatmentsScreened for Body Mass Index117 Participants
Usual CareProvision of Appropriate Preventive and Medical TreatmentsScreened for Lipids41 Participants
Usual CareProvision of Appropriate Preventive and Medical TreatmentsScreened for Blood Pressure131 Participants
Other Pre-specified

Patient Psychopathology: Behavior and Symptom Identification Scale (BASIS-R) Depression Daily Functioning

Assesses patient psychopathology in the domain of depression/daily functioning. Scores range from 0 to 4. Higher scores mean a worse outcome.

Time frame: 15 months

Population: These are the number of subjects for whom data was available for this measure during the relevant time frame.

ArmMeasureValue (MEAN)Dispersion
SMI-PACTPatient Psychopathology: Behavior and Symptom Identification Scale (BASIS-R) Depression Daily Functioning1.63 score on a scaleStandard Deviation 0.68
Usual CarePatient Psychopathology: Behavior and Symptom Identification Scale (BASIS-R) Depression Daily Functioning1.71 score on a scaleStandard Deviation 0.72
Other Pre-specified

Patient Psychopathology: Behavior and Symptom Identification Scale (BASIS-R) Interpersonal Functioning

Assesses patient psychopathology in the domain of interpersonal functioning. Scores range from 0 to 4. Lower scores mean a worse outcome.

Time frame: 15 months

Population: These are the number of subjects for whom data was available for this measure during the relevant time frame.

ArmMeasureValue (MEAN)Dispersion
SMI-PACTPatient Psychopathology: Behavior and Symptom Identification Scale (BASIS-R) Interpersonal Functioning2.42 score on a scaleStandard Deviation 0.89
Usual CarePatient Psychopathology: Behavior and Symptom Identification Scale (BASIS-R) Interpersonal Functioning2.39 score on a scaleStandard Deviation 0.89
Other Pre-specified

Patient Psychopathology: Behavior and Symptom Identification Scale (BASIS-R) Psychosis

Assesses patient psychopathology in the domain of psychosis. Scores range from 0 to 4. Higher scores mean a worse outcome.

Time frame: 15 months

Population: These are the number of subjects for whom data was available for this measure during the relevant time frame.

ArmMeasureValue (MEAN)Dispersion
SMI-PACTPatient Psychopathology: Behavior and Symptom Identification Scale (BASIS-R) Psychosis0.88 score on a scaleStandard Deviation 0.79
Usual CarePatient Psychopathology: Behavior and Symptom Identification Scale (BASIS-R) Psychosis0.65 score on a scaleStandard Deviation 0.71

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026