NCT01668355

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
331

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 7, 2012

Completed
13 days until next milestone

First Posted

Study publicly available on registry

August 20, 2012

Completed
3 years until next milestone

Study Start

First participant enrolled

September 1, 2015

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 6, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 6, 2019

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

February 28, 2020

Completed
Last Updated

February 28, 2020

Status Verified

February 1, 2020

Enrollment Period

3.4 years

First QC Date

August 7, 2012

Results QC Date

February 13, 2020

Last Update Submit

February 13, 2020

Conditions

Schizophrenia Spectrum & Other Psychotic Disorders

Keywords

Delivery of HealthcareHealth Services ResearchIntegrated Healthcare SystemsHealthcare Quality, Access, and EvaluationPrimary CareQuality ImprovementPsychotic DisordersMedical HomePsychiatryPatient Care ManagementNursing Care ManagementTreatment Costs

Outcome Measures

Primary Outcomes (5)

  • Provision of Appropriate Preventive and Medical Treatments

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

    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.

    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.

    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.

    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.

    15 months

Other Outcomes (3)

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

    15 months

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

    15 months

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

    15 months

Study Arms (2)

SMI-PACT

EXPERIMENTAL

Patient Aligned Care Team (PACT) medical home model to address the physical healthcare needs of individuals with serious mental illness

Other: Patient Aligned Care Team (PACT)

Usual Care

NO INTERVENTION

Usual Primary Care

Interventions

Patient Aligned Care Team (PACT)OTHER

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.

Also known as: SMI-PACT
SMI-PACT

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

VA San Diego Healthcare System, San Diego, CA

San Diego, California, 92161, United States

Location

VA Greater Los Angeles Healthcare System, West Los Angeles, CA

West Los Angeles, California, 90073, United States

Location

VA Southern Nevada Healthcare System, North Las Vegas, NV

Las Vegas, Nevada, 89106, United States

Location

Related Publications (2)

  • 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.

    PMID: 29880047RESULT

  • Young 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.

    PMID: 35380346DERIVED

MeSH Terms

Conditions

Schizophrenia Spectrum and Other Psychotic DisordersPsychotic Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Results Point of Contact

Title
Alexander Young
Organization
VA
alexander.young@va.gov
310-794-7219

Study Officials

  • Alexander S Young, MD MSHS

    VA Greater Los Angeles Healthcare System, West Los Angeles, CA

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: medical home tailored for people with serious mental illness
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 7, 2012

First Posted

August 20, 2012

Study Start

September 1, 2015

Primary Completion

February 6, 2019

Study Completion

February 6, 2019

Last Updated

February 28, 2020

Results First Posted

February 28, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

US(3)