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

Adverse Drug Event Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02689076
• Other study ID #: IIR 14-049
• Status: Completed
• Phase: N/A
• Start date: March 14, 2016
• Est. completion date: April 5, 2020

Study information

• Verified date: July 2023
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 796
• Est. completion date: April 5, 2020
• Est. primary completion date: April 5, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adverse Drug Event
• Cost
• Drug-Related Side Effects and Adverse Reactions
• Patient Readmission

Intervention

Other:
• HIE Notification
VA provider notification of non-VA hospitalization or ED visit via electronic health information exchange
• Care transitions intervention
Post-hospital geriatrics care transitions coordinator provides home visit and telephone support for 30 days after hospital discharge

Locations

Country	Name	City	State
United States	James J. Peters VA Medical Center, Bronx, NY	Bronx	New York
United States	Richard L. Roudebush VA Medical Center, Indianapolis, IN	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (8)

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 C — View 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. — View 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 I — View 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 — View 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 — View 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):

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-A — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	90 days
Secondary	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.	30 days
Secondary	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.	30 days
Secondary	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.	30 days