NCT04521816

Brief 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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
599

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2017

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

October 1, 2017

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2018

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

July 8, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 21, 2020

Completed
Last Updated

August 21, 2020

Status Verified

August 1, 2020

Enrollment Period

12 months

First QC Date

July 8, 2020

Last Update Submit

August 17, 2020

Conditions

Primary Health CareHealth Care Costs

Keywords

High-Risk Patients, Complex patients

Outcome Measures

Primary Outcomes (1)

  • VA health care cost

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

    2 years (two 1-year points)

Secondary Outcomes (3)

  • Healthcare Utilization

    2 years (two 1-year points)

  • Total Medicare Cost

    2 years (two 1-year points)

  • Total Medicare Utilization

    2 years (two 1-year points)

Other Outcomes (22)

  • Functional status- General

    2 years (two 1-year points)

  • Functional Status- Social

    2 years (two 1-year points)

  • Functional status- ADLS

    2 years (two 1-year points)

  • +19 more other outcomes

Study Arms (2)

Intervention--PACT Intensive Management

EXPERIMENTAL

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

Usual care

NO INTERVENTION

High-Risk patients receiving care in PACT.

Interventions

PACT Intensive ManagementBEHAVIORAL

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
Intervention--PACT Intensive Management

Eligibility Criteria

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

You may qualify if:

  • Refered for intensive management

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VAGLAHS

Los Angeles, California, 90073, United States

Location

Related Publications (1)

  • Chang ET, Huynh A, Yoo C, Yoon J, Zulman DM, Ong MK, Klein M, Eng J, Roy S, Stockdale SE, Jimenez EE, Denietolis A, Needleman J, Asch SM; PACT Intensive Management (PIM) Demonstration Sites, PIM National Evaluation Center, and PIM Executive Committee. Impact of Referring High-Risk Patients to Intensive Outpatient Primary Care Services: A Propensity Score-Matched Analysis. J Gen Intern Med. 2025 Feb;40(3):637-646. doi: 10.1007/s11606-024-08923-3. Epub 2024 Jul 29.

    PMID: 39075268DERIVED

Study Officials

  • Evelyn Chang, MD

    VAGLAHS- WLA

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 8, 2020

First Posted

August 21, 2020

Study Start

October 1, 2017

Primary Completion

September 30, 2018

Study Completion

September 30, 2018

Last Updated

August 21, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)