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

Primary Purpose

Patient Readmission, Adverse Drug Event, Cost

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
HIE Notification
Care transitions intervention
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Patient Readmission focused on measuring Patient transfer, Patient care management, Health information exchange

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Richard L. Roudebush VA Medical Center, Indianapolis, IN
  • James J. Peters VA Medical Center, Bronx, NY

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

HIE Notification plus Care Coordination

HIE Notification alone

Usual Care (No HIE Notification and No Care Coordination)

Arm Description

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 via electronic health information exchange (HIE) followed by usual post-hospital care

Absence of VA provider notification of non-VA hospitalization via HIE plus Absence of post-hospital geriatric care transitions intervention [Usual Care]

Outcomes

Primary Outcome Measures

Number of Participants With Hospital Readmission
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)

Secondary Outcome Measures

Number of Participants With Scheduled Follow-up
VA follow-up visit with a VA provider (physician or nurse practitioner) within 30 days of non-VA hospital discharge or ED visit.
Number of High-risk Medication Discrepancies
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.
Care Transitions Measure Score
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.

Full Information

First Posted
February 18, 2016
Last Updated
July 19, 2023
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT02689076
Brief Title
Regional Data Exchange to Improve Care for Veterans After Non-VA Hospitalization
Official Title
Regional Data Exchange to Improve Care for Veterans After Non-VA Hospitalization
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
March 14, 2016 (Actual)
Primary Completion Date
April 5, 2020 (Actual)
Study Completion Date
April 5, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patient Readmission, Adverse Drug Event, Cost
Keywords
Patient transfer, Patient care management, Health information exchange

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
796 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HIE Notification plus Care Coordination
Arm Type
Experimental
Arm Description
VA provider notification of non-VA hospitalization via electronic health information exchange (HIE) plus post-hospital geriatric care transitions intervention
Arm Title
HIE Notification alone
Arm Type
Active Comparator
Arm Description
VA provider notification of non-VA hospitalization via electronic health information exchange (HIE) followed by usual post-hospital care
Arm Title
Usual Care (No HIE Notification and No Care Coordination)
Arm Type
No Intervention
Arm Description
Absence of VA provider notification of non-VA hospitalization via HIE plus Absence of post-hospital geriatric care transitions intervention [Usual Care]
Intervention Type
Other
Intervention Name(s)
HIE Notification
Intervention Description
VA provider notification of non-VA hospitalization or ED visit via electronic health information exchange
Intervention Type
Other
Intervention Name(s)
Care transitions intervention
Intervention Description
Post-hospital geriatrics care transitions coordinator provides home visit and telephone support for 30 days after hospital discharge
Primary Outcome Measure Information:
Title
Number of Participants With Hospital Readmission
Description
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)
Time Frame
90 days
Secondary Outcome Measure Information:
Title
Number of Participants With Scheduled Follow-up
Description
VA follow-up visit with a VA provider (physician or nurse practitioner) within 30 days of non-VA hospital discharge or ED visit.
Time Frame
30 days
Title
Number of High-risk Medication Discrepancies
Description
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.
Time Frame
30 days
Title
Care Transitions Measure Score
Description
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.
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kenneth S Boockvar, MD MS
Organizational Affiliation
James J. Peters Veterans Affairs Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Richard L. Roudebush VA Medical Center, Indianapolis, IN
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202-2884
Country
United States
Facility Name
James J. Peters VA Medical Center, Bronx, NY
City
Bronx
State/Province
New York
ZIP/Postal Code
10468-3904
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29295436
Citation
Dixon BE, Boockvar KS. Event Notification in Support of Population Health: The Promise and Challenges from a Randomized Controlled Trial. Stud Health Technol Inform. 2017;245:1357.
Results Reference
result
PubMed Identifier
31272427
Citation
Dixon BE, Schwartzkopf AL, Guerrero VM, May J, Koufacos NS, Bean AM, Penrod JD, Schubert CC, Boockvar KS. Regional data exchange to improve care for veterans after non-VA hospitalization: a randomized controlled trial. BMC Med Inform Decis Mak. 2019 Jul 4;19(1):125. doi: 10.1186/s12911-019-0849-1.
Results Reference
result
Citation
Franzosa E, Traylor MH, Aquino VG, Judon K, Schwartzkopf A, Dixon BE, Boockvar K. Care Team Members' Perceptions of an Informatics Intervention to Improve Geriatric Care Across Multiple sites. [Abstract]. Innovation in aging. 2020 Dec 16; 4(Supplement_1):519.
Results Reference
result
PubMed Identifier
33997903
Citation
Franzosa E, Traylor M, Judon KM, Guerrero Aquino V, Schwartzkopf AL, Boockvar KS, Dixon BE. Perceptions of event notification following discharge to improve geriatric care: qualitative interviews of care team members from a 2-site cluster randomized trial. J Am Med Inform Assoc. 2021 Jul 30;28(8):1728-1735. doi: 10.1093/jamia/ocab074.
Results Reference
result
PubMed Identifier
33832998
Citation
Kartje R, Dixon BE, Schwartzkopf AL, Guerrero V, Judon KM, Yi JC, Boockvar K. Characteristics of Veterans With Non-VA Encounters Enrolled in a Trial of Standards-Based, Interoperable Event Notification and Care Coordination. J Am Board Fam Med. 2021 Mar-Apr;34(2):301-308. doi: 10.3122/jabfm.2021.02.200251.
Results Reference
result
PubMed Identifier
34053407
Citation
Koufacos NS, May J, Judon KM, Franzosa E, Dixon BE, Schubert CC, Schwartzkopf AL, Guerrero VM, Traylor M, Boockvar KS. Improving Patient Activation among Older Veterans: Results from a Social Worker-Led Care Transitions Intervention. J Gerontol Soc Work. 2022 Jan;65(1):63-77. doi: 10.1080/01634372.2021.1932003. Epub 2021 May 30.
Results Reference
result
PubMed Identifier
34597411
Citation
Dixon BE, Judon KM, Schwartzkopf AL, Guerrero VM, Koufacos NS, May J, Schubert CC, Boockvar KS. Impact of event notification services on timely follow-up and rehospitalization among primary care patients at two Veterans Affairs Medical Centers. J Am Med Inform Assoc. 2021 Nov 25;28(12):2593-2600. doi: 10.1093/jamia/ocab189.
Results Reference
result
PubMed Identifier
35199262
Citation
Boockvar KS, Koufacos NS, May J, Schwartzkopf AL, Guerrero VM, Judon KM, Schubert CC, Franzosa E, Dixon BE. Effect of Health Information Exchange Plus a Care Transitions Intervention on Post-Hospital Outcomes Among VA Primary Care Patients: a Randomized Clinical Trial. J Gen Intern Med. 2022 Dec;37(16):4054-4061. doi: 10.1007/s11606-022-07397-5. Epub 2022 Feb 23.
Results Reference
result

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

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