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CompletedNCT04521816PIM2Updated Aug 21, 2020

PIM 2.0: Patient Aligned Care Team (PACT) Intensive Management (PIM) Project

An interventional study of PACT Intensive Management in Primary Health Care and Health Care Costs, sponsored by Veteran Affairs Office of Patient Care Services. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-08-21.

Sponsored by Veteran Affairs Office of Patient Care Services · Not applicable, Interventional, and Health services research

From the registry’s dates

  • Registered 2 years 9 months after the study started (first participant enrolled Oct 2017, registered Jul 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
599
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

Purpose: Implement a Patient Aligned Care Team (PACT) model that identifies and proactively manages Veterans at the highest risk for hospital admission and death while the patient is still in the ambulatory care setting.

Goal:

  • Reduce emergency department and urgent care utilization, hospitalization, and mortality in complex, high risk patients
  • Improve Veteran and staff satisfaction

Objectives:

  • Maintain the patient in the home setting as much as possible
  • Secure appropriate home environment to facilitate health and well-being
  • Utilize comprehensive team-based care
  • Engage appropriate Veteran Health Administration (VHA) programs to provide interdisciplinary, coordinated, and timely management of complex medical issues
02

Conditions studied

  • Primary Health Care
  • Health Care Costs

Keywords

  • High-Risk Patients, Complex patients
03

In context

Lead sponsor

Veteran Affairs Office of Patient Care Services is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Refered for intensive management

Exclusion criteria

Exclusion Criteria:

  • None
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
599 participants (actual)

Study arms

  • Experimental
    Intervention--PACT Intensive Management

    The intervention is the PACT Intensive Management Program (PIM) provides a standardized menu of services, ranging from chart review assessment or in-home assessment, to a time limited intensive care management intervention. The following PIM features are standardized across the PIM demonstration sites: A) Chart review assessment template in the EMR; B) Comprehensive assessment template of unmet needs and modifiable risk factors in EMR; C) Transitions in care process (eligibility criteria, clinical protocols); D) Diagnostic home visits process (eligibility criteria, clinical protocols); E) Core risk stratification/Triage process; F) Discharge criteria and note template in EMR; G) Standardized interdisciplinary team (IDT) meeting note procedure and template in EMR.

    Behavioral: PACT Intensive Management

  • No intervention
    Usual care

    High-Risk patients receiving care in PACT.

Interventions

  • BehavioralPACT Intensive Management

    Purpose: Implement a Patient Aligned Care Team (PACT) model that identifies and proactively manages Veterans at the highest risk for hospital admission and death while they are still in the ambulatory care setting. Goal: * Reduce emergency department and urgent care utilization, hospitalization, and mortality in complex, high risk patients * Improve Veteran and staff satisfaction Objectives: * Maintain the patient in the home setting as much as possible * Secure appropriate home environment to facilitate health and well-being * Utilize comprehensive team-based care * Engage appropriate VHA programs to provide interdisciplinary, coordinated, and timely management of complex medical issues

    Also known as: PIM

06

What researchers measure

Primary outcomes

  1. VA health care cost

    Total costs of VA care, including inpatient, outpatient, pharmacy and fee-basis services.

    Time frame: 2 years (two 1-year points)

Secondary outcomes

  1. Healthcare Utilization

    VA central repository administrative data will be analyzed to calculate utilization of hospital, emergency and outpatient primary and specialty care. This information will be electronically abstracted through the VA central repository administrative data center

    Time frame: 2 years (two 1-year points)

  2. Total Medicare Cost

    Data will be extracted from VHA's Corporate Data Warehouse to capture patient Medicare cost. Medicare claims data to measure total patient inpatient and outpatient cost for services reimbursed by Medicare. Inpatient cost will be measured as cost for total acute hospitalizations, and subcategories: medical, surgical, psychiatric, rehabilitation, hospice and ambulatory care-sensitive conditions. Outpatient cost will be measured as the cost for combined visits in VHA and elsewhere reimbursed by Medicare in 9 categories: primary care, specialty care, mental health, surgical, home health, nursing home, diagnostic, rehabilitation and ED.

    Time frame: 2 years (two 1-year points)

  3. Total Medicare Utilization

    Data will be extracted from VHA's Corporate Data Warehouse to capture patient utilization. Medicare claims data to measure total patient inpatient and outpatient utilization for services reimbursed by Medicare. Inpatient utilization will be measured as counts of total acute hospitalizations, and subcategories: medical, surgical, psychiatric, rehabilitation, hospice and ambulatory care-sensitive conditions. Outpatient utilization will be measured as the number of combined visits in VHA and elsewhere reimbursed by Medicare in 9 categories: primary care, specialty care, mental health, surgical, home health, nursing home, diagnostic, rehabilitation and ED.

    Time frame: 2 years (two 1-year points)

Other outcomes

  1. Functional status- General

    Patient report of their physical, social, and mental functional status is routinely collected as part of their medical visit as health factor data. The data will be abstracted through the VA central repository administrative data. The variables used to measure functional status are the following: •In general, please rate how well you carry out your usual social activities and roles. (This includes activities at home, at work and in your community, and responsibilities as a parent, child, spouse, employee, friend, etc.) (Excellent, Very good, Good, Fair, Poor)

    Time frame: 2 years (two 1-year points)

  2. Functional Status- Social

    Patient report of their physical, social, and mental functional status is routinely collected as part of their medical visit as health factor data. The data will be abstracted through the VA central repository administrative data. The variables used to measure functional status are the following: •In general, how would you rate your satisfaction with your social activities and relationships? (Excellent, Very good, Good, Fair, Poor)

    Time frame: 2 years (two 1-year points)

  3. Functional status- ADLS

    Patient report of their physical, social, and mental functional status is routinely collected as part of their medical visit as health factor data. The data will be abstracted through the VA central repository administrative data. The variables used to measure functional status are the following: •Administer Katz Index of Independence in Activities of Daily Living (Independence=1 point; dependence = 0 points for each of the six item pairs)

    Time frame: 2 years (two 1-year points)

  4. Functional status- IDLS

    Patient report of their physical, social, and mental functional status is routinely collected as part of their medical visit as health factor data. The data will be abstracted through the VA central repository administrative data. The variables used to measure functional status are the following: •Administer the Lawton Instrumental Activities of Daily Living (IADL) Scale (score 0-8)

    Time frame: 2 years (two 1-year points)

  5. Patient Quality of Life Status

    Patient assessment of their quality of life collected as part of their medical care as a health factor. This information will be electronically abstracted through the VA central repository administrative data center. The variables used to assess a patient's quality of life are the following: * Patient's self-rating of quality of life in general: Excellent, Very Good, Good, Fair, Poor * Patient's self-rating of mental health, including mood and ability to think: Excellent, Very Good, Good, Fair, Poor

    Time frame: 2 years (two 1-year points)

  6. Patient Symptom Burden

    Patient assessment of symptom burden is routinely collected as part of their care and documented in their medical record and will be electronically abstracted through the VA central repository administrative data center. Mental Health and physical burdens are abstracted from the medical record utilizing ICD-9 and ICD-10 code. It will be assessed as yes/no if present.

    Time frame: 2 years (two 1-year points)

  7. Anxiety

    Generalized Anxiety Disorder 2-item (GAD-2): (Not at all; several days; More than half the days, nearly every day). The higher the score the higher the anxiety.

    Time frame: 2 years (two 1-year points)

  8. Substance Abuse

    The 3-item AUDIT-C scored on a scale of 0-12; Drugs: How many times in the past year, have you used an illegal drug or used a prescription medication for nonmedical reasons? (Yes/No, Number of times). The greater the score the worse the substance abuse status.

    Time frame: 2 years (two 1-year points)

  9. Cognitive Status

    The Blessed-Short and/or the Mini-Cog where the lower the score the more impairment.

    Time frame: 2 years (two 1-year points)

  10. Pain level

    Pain in past 24 hours on scale of 0 = no pain, to 10 = worst pain imaginable.

    Time frame: 2 years (two 1-year points)

  11. Shortness of Breath

    Shortness of breath in past 24 hours on a scale of 0, no shortness of breath, to 10, worst imaginable.

    Time frame: 2 years (two 1-year points)

  12. Problems with constipation

    Constipation in past 24 hours on a scale from 0, no constipation, to 10, worst imaginable.

    Time frame: 2 years (two 1-year points)

  13. Sleep Problems

    Sleep problems in past 24 hours on a scale from 0, no sleep problems, to 10, worst imaginable.

    Time frame: 2 years (two 1-year points)

  14. Level of Fatigue

    Fatigue in past 24 hours on a scale from 0, no fatigue, to 10, worst imaginable.

    Time frame: 2 years (two 1-year points)

  15. Risk of Falls

    Falls (Patient reports no falls in past 12 months;Patient reports no problems with walking or balance; Patient reports problems with walking or balance; Patients reports falls in past 12 months

    Time frame: 2 years (two 1-year points)

  16. Patient Satisfaction-Trust

    I have a VA healthcare provider who I can trust. 1: Very dissatisfied 2: Dissatisfied 3: Somewhat dissatisfied 4: Somewhat satisfied 5: Satisfied 6: Very satisfied

    Time frame: 2 years (two 1-year points)

  17. Patient Satisfaction- Care Coordination

    I have a VA healthcare provider who helps coordinate my care from different doctors and services. 1: Very dissatisfied 2: Dissatisfied 3: Somewhat dissatisfied 4: Somewhat satisfied 5: Satisfied 6: Very satisfied

    Time frame: 2 years (two 1-year points)

  18. Patient Satisfaction- Access

    I got the service I needed. 1: Very dissatisfied 2: Dissatisfied 3: Somewhat dissatisfied 4: Somewhat satisfied 5: Satisfied 6: Very satisfied

    Time frame: 2 years (two 1-year points)

  19. Patient Satisfaction- Goals

    In the last 6 months, did someone at the VA talk with you about specific goals for your health. 1: Very dissatisfied 2: Dissatisfied 3: Somewhat dissatisfied 4: Somewhat satisfied 5: Satisfied 6: Very satisfied

    Time frame: 2 years (two 1-year points)

  20. Patient Satisfaction- Help with Barriers

    In the last 6 months, did someone at the VA ask you if there are things that make it hard for you to take care of your health. 1: Very dissatisfied 2: Dissatisfied 3: Somewhat dissatisfied 4: Somewhat satisfied 5: Satisfied 6: Very satisfied

    Time frame: 2 years (two 1-year points)

  21. Patient Satisfaction- overall facility

    Overall, how satisfied are you with the health care you have received at your VA facility? 1. Very dissatisfied 2. Dissatisfied 3. Somewhat dissatisfied 4. Somewhat satisfied 5. Satisfied 6. Very satisfied

    Time frame: 2 years (two 1-year points)

  22. Patient Satisfaction- overall provider

    is the best provider possible, what number would you use to rate this provider? 1. Very dissatisfied 2. Dissatisfied 3. Somewhat dissatisfied 4. Somewhat satisfied 5. Satisfied 6. Very satisfied

    Time frame: 2 years (two 1-year points)

07

Study locations

1 site
  • VAGLAHS
    Los Angeles, California 90073, United States
08

References and documents

Study documents

  • Study protocol · Jul 8, 2020

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 21, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04521816
Lead sponsor
Veteran Affairs Office of Patient Care Services
Collaborators
VA Office of Research and Development, VA Palo Alto Health Care System, US Department of Veterans Affairs
Responsible party
Sponsor
First posted
Aug 21, 2020
Start date
Oct 1, 2017
Primary completion
Sep 30, 2018
Completion
Sep 30, 2018
Last update
Aug 21, 2020

Study contacts

Evelyn Chang, MD
principal investigator · VAGLAHS- WLA

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.

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