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Completed

NCT Number: NCT04521816

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VAGLAHS

Los Angeles, California, 90073, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Refered for intensive management

Exclusion criteria

  • None

Treatment and study plan

PACT Intensive Management

Behavioral

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

Other names: PIM

Primary outcomes

  1. VA health care cost

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

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

Secondary outcomes

  1. Healthcare Utilization

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

    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

  2. Total Medicare Cost

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

    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.

  3. Total Medicare Utilization

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

    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.

Other outcomes

  1. Functional status- General

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

    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)

  2. Functional Status- Social

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

    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)

  3. Functional status- ADLS

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

    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)

  4. Functional status- IDLS

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

    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)

  5. Patient Quality of Life Status

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

    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
  6. Patient Symptom Burden

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

    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.

  7. Anxiety

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

    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.

  8. Substance Abuse

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

    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.

  9. Cognitive Status

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

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

  10. Pain level

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

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

  11. Shortness of Breath

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

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

  12. Problems with constipation

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

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

  13. Sleep Problems

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

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

  14. Level of Fatigue

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

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

  15. Risk of Falls

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

    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

  16. Patient Satisfaction-Trust

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

    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

  17. Patient Satisfaction- Care Coordination

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

    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

  18. Patient Satisfaction- Access

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

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

  19. Patient Satisfaction- Goals

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

    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

  20. Patient Satisfaction- Help with Barriers

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

    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

  21. Patient Satisfaction- overall facility

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

    Overall, how satisfied are you with the health care you have received at your VA facility?

    • Very dissatisfied
    • Dissatisfied
    • Somewhat dissatisfied
    • Somewhat satisfied
    • Satisfied
    • Very satisfied
  22. Patient Satisfaction- overall provider

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

    is the best provider possible, what number would you use to rate this provider?

    • Very dissatisfied
    • Dissatisfied
    • Somewhat dissatisfied
    • Somewhat satisfied
    • Satisfied
    • Very satisfied

Sponsors and collaborators

Lead sponsor

Veteran Affairs Office of Patient Care Services

Fed

Collaborators

  • US Department of Veterans Affairs
  • VA Office of Research and Development
  • VA Palo Alto Health Care System

Registry information

Acronym: PIM2

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Aug 21, 2020
Registry last updated
Aug 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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