NCT03100526

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

100
On Track

Trial Health Score

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

Enrollment
2,210

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2013

Longer than P75 for not_applicable

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

November 1, 2013

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

February 10, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 4, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

May 11, 2020

Status Verified

May 1, 2020

Enrollment Period

3.8 years

First QC Date

February 10, 2017

Last Update Submit

May 6, 2020

Conditions

Primary Health CareHealth Care Costs

Keywords

High-Risk 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 (16)

  • Patient Engagement

    2 years (two 1-year points)

  • Functional status

    2 years (two 1-year points)

  • Patient Quality of Life Status

    2 years (two 1-year points)

  • +13 more other outcomes

Study Arms (2)

Intervention--PACT Intensive Management

EXPERIMENTAL

The intervention is the PACT Intensive Management Program (PIM) which provides intensive interdisciplinary care planning, care coordination, patient self-management support, and tailored goal setting based on patient needs and preferences, and additional care management services.

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:

  • selected for intensive management

You may not qualify if:

  • enrolled in other intensive case management at VA

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Yoon J, Chang E, Rubenstein LV, Park A, Zulman DM, Stockdale S, Ong MK, Atkins D, Schectman G, Asch SM. Impact of Primary Care Intensive Management on High-Risk Veterans' Costs and Utilization: A Randomized Quality Improvement Trial. Ann Intern Med. 2018 Jun 19;168(12):846-854. doi: 10.7326/M17-3039. Epub 2018 Jun 5.

    PMID: 29868706DERIVED

  • Chang ET, Zulman DM, Asch SM, Stockdale SE, Yoon J, Ong MK, Lee M, Simon A, Atkins D, Schectman G, Kirsh SR, Rubenstein LV; PIM Executive Committee and Demonstration Sites. An operations-partnered evaluation of care redesign for high-risk patients in the Veterans Health Administration (VHA): Study protocol for the PACT Intensive Management (PIM) randomized quality improvement evaluation. Contemp Clin Trials. 2018 Jun;69:65-75. doi: 10.1016/j.cct.2018.04.008. Epub 2018 Apr 23.

    PMID: 29698772DERIVED

Study Officials

  • Lisa Rubenstein, MD

    VAGLAHS- WLA

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

February 10, 2017

First Posted

April 4, 2017

Study Start

November 1, 2013

Primary Completion

September 1, 2017

Study Completion

September 1, 2017

Last Updated

May 11, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share