Regional Data Exchange to Improve Care for Veterans After Non-VA Hospitalization

July 19, 2023 updated by: VA Office of Research and Development
Among older VA patients who have Medicare coverage, 43% use both VA and non-VA (Medicare-covered) services. VA and non-VA providers are often uninformed about encounters, treatments and test results provided in the other system. The overall objective of this project is to examine the impact of VA provider notification of non-VA hospitalization or emergency department (ED) visit using electronic health information exchange (HIE), along with provision of post-hospital care coordination services. The investigators will examine the impact of these approaches on preventing hospital readmission, increasing provider follow-up, improving patient's self-knowledge, and preventing medication errors. The investigators will also examine the effect of these approaches on VA and non-VA costs. Finally the investigators will examine the acceptance of these approaches among VA and non-VA providers. The study sample will consist of Veterans followed in geriatrics or primary care clinics at the Bronx and Indianapolis VAs who are older than 65. The investigators will monitor patients for non-VA hospital admission or ED visit using technology provided by health information exchange organizations. Patients will be assigned to enhanced or control treatment groups. For both groups the VA provider will receive an electronic notification of a non-VA hospital admission or ED visit if it occurs. For the enhanced group, a care transitions coordinator will deliver post-hospital coordination services during a home and/or VA facility visit and follow-up phone calls over 1 month. The investigators' analyses will compare effects of notification-plus-coordination versus notification-only on health care outcomes. The investigators will conduct interviews with intervention team members, patients, VA and non-VA staff, and other stakeholders to ascertain the barriers and facilitators to implementation of these approaches.

Study Overview

Detailed Description

Background: Among older VA patients who have Medicare coverage, 43% use both VA and non-VA (Medicare-covered) services. VA and non-VA providers are often uninformed about encounters, treatments and test results provided in the other system. In particular, the absent or delayed notification of a non-VA hospital encounter is a missed opportunity for the VA to provide post-hospital transitional care services that have been shown to be effective in preventing adverse events and hospital readmission after hospital discharge. Objectives: The overall objective of this project is to examine the effectiveness, cost, and implementation acceptance of VA provider notification of non-VA hospitalization or emergency department (ED) visit using electronic health information exchange (HIE), with or without provision of evidence-based post-hospital transitional care services. Specific Aim 1 is to examine the impact of these approaches on preventing hospital admission or readmission as the primary outcome, and, as secondary outcomes, increasing provider follow-up, improving patient's condition self-knowledge, and preventing medication errors after discharge. been shown to be effective in preventing adverse events and hospital readmission after hospital discharge.

Specific Aim 2 is to examine the effect of these approaches on VA and non-VA costs. Specific Aim 3 is to examine the acceptance of these approaches among VA and non-VA stakeholders.

Methods: The study sample consists of Veterans followed in geriatrics or primary care clinics at the Bronx and Indianapolis VAs who are older than 65. The investigators will monitor patients for non-VA hospital admission or ED visit using technology provided by regional HIE organizations (i.e., the Bronx Regional Health Information Organization and the Indiana Health Information Exchange). Patients will be cluster-randomized 1:1 to notification-plus-coordination or notification-only groups by PACT team, stratified by facility. For both groups the PACT provider will receive real-time notification of a non-VA hospital admission or ED visit if it occurs. For the notification-plus-coordination group, a care transitions coordinator will deliver coordination activities during a home and/or VA facility visit and via follow-up phone calls over 1 month. Coordination activities will consist of: reconciliation of and counseling on the patient's VA and non-VA medications, education on signs of condition worsening, coordination of VA and non-VA follow-up appointments, and counseling on communicating with VA and non-VA providers, using structured protocols. All information-gathering by the transitions coordinator will include the HIE as an information source. The notification-only group will receive usual care after the notification. Multivariable regression models will be estimated to compare effects of notification-plus-coordination versus notification-only on primary and secondary outcomes and costs (Aims 1 and 2). The investigators will conduct interviews with intervention team members, patients, VA and non-VA staff, and other stakeholders to ascertain the barriers and facilitators to implementation of these approaches (Aim 3).

Study Type

Interventional

Enrollment (Actual)

796

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Indiana
      • Indianapolis, Indiana, United States, 46202-2884
        • Richard L. Roudebush VA Medical Center, Indianapolis, IN
    • New York
      • Bronx, New York, United States, 10468-3904
        • James J. Peters VA Medical Center, Bronx, NY

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • established patient in a Bronx VA or Indianapolis VA geriatrics or primary care clinic
  • 65 years or older
  • be consented in the local health information exchange
  • have utilized any non-VA services in the previous two years, including:

    • nursing
    • lab
    • physician
    • pharmacy
    • and/or hospital services

Exclusion Criteria:

  • Refusal to sign informed consent or consent to access local health information exchange
  • Enrolled in hospice at baseline
  • Enrolled in Geriatric Resources and Care for Elders (GRACE) program (Indianapolis) at baseline

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HIE Notification plus Care Coordination
VA provider notification of non-VA hospitalization via electronic health information exchange (HIE) plus post-hospital geriatric care transitions intervention
VA provider notification of non-VA hospitalization or ED visit via electronic health information exchange
Post-hospital geriatrics care transitions coordinator provides home visit and telephone support for 30 days after hospital discharge
Active Comparator: HIE Notification alone
VA provider notification of non-VA hospitalization via electronic health information exchange (HIE) followed by usual post-hospital care
VA provider notification of non-VA hospitalization or ED visit via electronic health information exchange
No Intervention: Usual Care (No HIE Notification and No Care Coordination)
Absence of VA provider notification of non-VA hospitalization via HIE plus Absence of post-hospital geriatric care transitions intervention [Usual Care]

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Hospital Readmission
Time Frame: 90 days
Percentage of patients with VA and non-VA hospital admission or readmission 90 days after non-VA hospital or ED discharge (or, if the patient is not discharged home, 90 days after discharge home from a rehabilitation facility)
90 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Scheduled Follow-up
Time Frame: 30 days
VA follow-up visit with a VA provider (physician or nurse practitioner) within 30 days of non-VA hospital discharge or ED visit.
30 days
Number of High-risk Medication Discrepancies
Time Frame: 30 days
The number of discrepancies in medications classified as high risk for hospitalized older adults, including opioid analgesics, insulin, non-steroidal anti-inflammatory drugs, digoxin, antipsychotics, sedatives/hypnotics, and anticoagulants based on medical record review and patient or caregiver interview 30 days after non-VA hospital discharge.
30 days
Care Transitions Measure Score
Time Frame: 30 days
A measure of condition self-knowledge and transitional care quality from the patient's perspective is ascertained by patient or caregiver interview 30 days after non-VA hospital discharge. The investigators will use an adapted 3-item version which includes items such as: "After I left the hospital, I had all the information I needed to be able to take care of myself" with the response options strongly agree, agree, disagree, strongly disagree, and don't know. The investigators chose to use the 3-item rather than a 15-item version as the shorter instrument demonstrates excellent correlation with the longer version but with lower respondent burden. Unabbreviated scale title is "3-Item Care Transitions Measure" and minimum value is 1 and maximum value is 12. Higher scores mean a better transition/outcome.
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Kenneth S Boockvar, MD MS, James J. Peters Veterans Affairs Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 14, 2016

Primary Completion (Actual)

April 5, 2020

Study Completion (Actual)

April 5, 2020

Study Registration Dates

First Submitted

February 18, 2016

First Submitted That Met QC Criteria

February 18, 2016

First Posted (Estimated)

February 23, 2016

Study Record Updates

Last Update Posted (Actual)

July 27, 2023

Last Update Submitted That Met QC Criteria

July 19, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

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

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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