NCT02932228

Brief Summary

This evaluation will examine the feasibility, implementation, and effectiveness of a quality improvement intervention-Intensive Management Patient Aligned Care Team (ImPACT)-for high-risk patients.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
583

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2013

Typical duration 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

January 1, 2013

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

October 6, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 13, 2016

Completed
2.6 years until next milestone

Results Posted

Study results publicly available

May 29, 2019

Completed
Last Updated

June 12, 2019

Status Verified

May 1, 2019

Enrollment Period

1.4 years

First QC Date

October 6, 2016

Results QC Date

April 6, 2018

Last Update Submit

May 30, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • VA Health Care Costs

    Estimated programs effect on cost among all patients, and correspond to the change in monthly costs among patients in impact minus the change in costs for patients in PACT.

    17 months

Secondary Outcomes (3)

  • Hospitalization

    17 months

  • Emergency Department Utilization

    17 months

  • Outpatient Utilization

    17 months

Other Outcomes (7)

  • Feasibility: Time to Enrollment

    9 months

  • Feasibility: Participation

    9 months

  • Implementation Process

    9 months

  • +4 more other outcomes

Study Arms (2)

ImPACT

EXPERIMENTAL

Patients in ImPACT receive intensive outpatient care from the ImPACT team. The ImPACT team augments existing PACT primary care with intensive services delivered by a multidisciplinary team (including a physician, nurse practitioner, social worker, recreational therapist, and program coordinator). ImPACT program elements include a comprehensive patient assessment, identification and tracking of patients' goals and priorities, care management for medical and social service needs, co-attendance at specialty care appointments, and coordination of care with VA and non-VA providers, including during and after hospitalization.

Other: ImPACT

PACT

NO INTERVENTION

Patients in PACT receive usual VA primary care through the VA's Patient Centered Medical Home. VA primary care is delivered by PACT teamlets that comprise a primary care provider, nurse, clinical associate, and administrative associate who are supported by social work, pharmacy, and behavioral health services.

Interventions

ImPACTOTHER

The ImPACT team offers the following services: * An intensive intake process, including a home visit if deemed appropriate * Frequent contact (in-person, telephone, or secure messaging) tailored to a patient's needs * After-hours access to on-call team member in order to avoid unnecessary emergency care * Optimization of chronic condition management using evidence-based protocols * Navigation of transitions between hospital and home * Coordination of specialty care, including contact with specialists when indicated * Rapid response to signs of health status deterioration or other stressful events * Assess patient goals, advance directives, Physician Orders for Life-Sustaining Treatment

ImPACT

Eligibility Criteria

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

You may qualify if:

  • Patient receives care from one of 14 primary care providers (MDs, NPs) who have at least three half-days of clinic per week
  • Total VA healthcare costs in the top 5% for VA Palo Alto facility during the 9-month eligibility phase (10/1/11-6/30/12) AND/OR
  • Risk for one-year hospitalization in November 2012 in the top 5% (using the VA's Care Assessment Need risk-prediction algorithm)

You may not qualify if:

  • Enrollment in VA's mental health intensive case management program, home-based primary care, or palliative care programs
  • Recipient of inpatient care for over half of the 9-month eligibility phase (10/1/11-6/30/12).
  • Total VA healthcare costs in the lowest cost decile in the 9-month eligibility phase (10/1/11-6/30/12)
  • Risk for one-year hospitalization in November 2012 in the lowest risk quartile (using the VA's Care Assessment Need risk-prediction algorithm).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (11)

  • Zulman DM, Jenchura EC, Cohen DM, Lewis ET, Houston TK, Asch SM. How Can eHealth Technology Address Challenges Related to Multimorbidity? Perspectives from Patients with Multiple Chronic Conditions. J Gen Intern Med. 2015 Aug;30(8):1063-70. doi: 10.1007/s11606-015-3222-9. Epub 2015 Feb 18.

    PMID: 25691239BACKGROUND
  • Zulman DM, Pal Chee C, Wagner TH, Yoon J, Cohen DM, Holmes TH, Ritchie C, Asch SM. Multimorbidity and healthcare utilisation among high-cost patients in the US Veterans Affairs Health Care System. BMJ Open. 2015 Apr 16;5(4):e007771. doi: 10.1136/bmjopen-2015-007771.

    PMID: 25882486BACKGROUND
  • Gidwani R, Zulman D. Association Between Acute Medical Exacerbations and Consuming or Producing Web-Based Health Information: Analysis From Pew Survey Data. J Med Internet Res. 2015 Jun 23;17(6):e145. doi: 10.2196/jmir.3801.

    PMID: 26104000BACKGROUND
  • Breland JY, Greenbaum MA, Zulman DM, Rosen CS. The effect of medical comorbidities on male and female Veterans' use of psychotherapy for PTSD. Med Care. 2015 Apr;53(4 Suppl 1):S120-7. doi: 10.1097/MLR.0000000000000284.

    PMID: 25767965BACKGROUND
  • Hunter G, Yoon J, Blonigen DM, Asch SM, Zulman DM. Health Care Utilization Patterns Among High-Cost VA Patients With Mental Health Conditions. Psychiatr Serv. 2015 Sep;66(9):952-8. doi: 10.1176/appi.ps.201400286. Epub 2015 May 1.

    PMID: 25930040BACKGROUND
  • Breland JY, Chee CP, Zulman DM. Racial Differences in Chronic Conditions and Sociodemographic Characteristics Among High-Utilizing Veterans. J Racial Ethn Health Disparities. 2015 Jun;2(2):167-75. doi: 10.1007/s40615-014-0060-0. Epub 2014 Nov 8.

    PMID: 26863335BACKGROUND
  • Hummel DL, Hill C, Shaw JG, Slightam C, Zulman DM. Nurse practitioner-led intensive outpatient team: Effects on end-of-life care. The Journal for Nurse Practitioners. 2017 Mar 14; 13(5):e245-e248

    BACKGROUND
  • Zulman DM, Ezeji-Okoye SC, Shaw JG, Hummel DL, Holloway KS, Smither SF, Breland JY, Chardos JF, Kirsh S, Kahn JS, Asch SM. Partnered research in healthcare delivery redesign for high-need, high-cost patients: development and feasibility of an Intensive Management Patient-Aligned Care Team (ImPACT). J Gen Intern Med. 2014 Dec;29 Suppl 4(Suppl 4):861-9. doi: 10.1007/s11606-014-3022-7.

  • Breland JY, Asch SM, Slightam C, Wong A, Zulman DM. Key ingredients for implementing intensive outpatient programs within patient-centered medical homes: A literature review and qualitative analysis. Healthc (Amst). 2016 Mar;4(1):22-9. doi: 10.1016/j.hjdsi.2015.12.005. Epub 2015 Dec 29.

  • Zulman DM, Pal Chee C, Ezeji-Okoye SC, Shaw JG, Holmes TH, Kahn JS, Asch SM. Effect of an Intensive Outpatient Program to Augment Primary Care for High-Need Veterans Affairs Patients: A Randomized Clinical Trial. JAMA Intern Med. 2017 Feb 1;177(2):166-175. doi: 10.1001/jamainternmed.2016.8021.

  • Wu FM, Slightam CA, Wong AC, Asch SM, Zulman DM. Intensive Outpatient Program Effects on High-need Patients' Access, Continuity, Coordination, and Engagement. Med Care. 2018 Jan;56(1):19-24. doi: 10.1097/MLR.0000000000000833.

Results Point of Contact

Title
Dr Donna Zulman
Organization
VA Palo Alto Health Care System

Study Officials

  • Donna M Zulman, MD MS

    VA Palo Alto Health Care System, Palo Alto, CA

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

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

October 6, 2016

First Posted

October 13, 2016

Study Start

January 1, 2013

Primary Completion

June 1, 2014

Study Completion

May 1, 2015

Last Updated

June 12, 2019

Results First Posted

May 29, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share