PIM 2.0: Patient Aligned Care Team (PACT) Intensive Management (PIM) Project (PIM2)

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

Study Overview

• Status: Completed
• Conditions: Primary Health Care; Health Care Costs
• Intervention / Treatment: Behavioral: PACT Intensive Management

• Study Type: Interventional
• Enrollment (Actual): 599
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90073
      • VAGLAHS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Refered for intensive management

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual care; High-Risk patients receiving care in PACT.
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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
VA health care cost	Total costs of VA care, including inpatient, outpatient, pharmacy and fee-basis services.	2 years (two 1-year points)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	2 years (two 1-year points)
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.	2 years (two 1-year points)
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.	2 years (two 1-year points)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	2 years (two 1-year points)
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.	2 years (two 1-year points)
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.	2 years (two 1-year points)
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.	2 years (two 1-year points)
Cognitive Status	The Blessed-Short and/or the Mini-Cog where the lower the score the more impairment.	2 years (two 1-year points)
Pain level	Pain in past 24 hours on scale of 0 = no pain, to 10 = worst pain imaginable.	2 years (two 1-year points)
Shortness of Breath	Shortness of breath in past 24 hours on a scale of 0, no shortness of breath, to 10, worst imaginable.	2 years (two 1-year points)
Problems with constipation	Constipation in past 24 hours on a scale from 0, no constipation, to 10, worst imaginable.	2 years (two 1-year points)
Sleep Problems	Sleep problems in past 24 hours on a scale from 0, no sleep problems, to 10, worst imaginable.	2 years (two 1-year points)
Level of Fatigue	Fatigue in past 24 hours on a scale from 0, no fatigue, to 10, worst imaginable.	2 years (two 1-year points)
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	2 years (two 1-year points)
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)	2 years (two 1-year points)
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)	2 years (two 1-year points)
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)	2 years (two 1-year points)
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)	2 years (two 1-year points)
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	2 years (two 1-year points)
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	2 years (two 1-year points)
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	2 years (two 1-year points)
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	2 years (two 1-year points)
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	2 years (two 1-year points)
Patient Satisfaction- overall facility	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	2 years (two 1-year points)
Patient Satisfaction- overall provider	is the best provider possible, what number would you use to rate this provider?; Very dissatisfied; Dissatisfied; Somewhat dissatisfied; Somewhat satisfied; Satisfied; Very satisfied	2 years (two 1-year points)

Collaborators and Investigators

• Sponsor: Veteran Affairs Office of Patient Care Services
• Collaborators: VA Office of Research and Development; VA Palo Alto Health Care System; VHA Primary Care Services
• Investigators: Principal Investigator: Evelyn Chang, MD, VAGLAHS- WLA

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2017
• Primary Completion (Actual): September 30, 2018
• Study Completion (Actual): September 30, 2018

Study Registration Dates

• First Submitted: July 8, 2020
• First Submitted That Met QC Criteria: August 17, 2020
• First Posted (Actual): August 21, 2020

Study Record Updates

• Last Update Posted (Actual): August 21, 2020
• Last Update Submitted That Met QC Criteria: August 17, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: High-Risk Patients, Complex patients
• Other Study ID Numbers: PIM #2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No