Clinical trial NCT01717976: Discharge Information and Support for Patients Receiving Outpatient Care in the Emergency Department
Official title: Discharge Information & Support for Patients Receiving Outpatient Care in the ED
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multimorbidity
Keywords: emergency department use
Veterans
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2012-10-31
Enrollment: 513
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The Veterans' Health Administration (VHA) is committed to improving primary care through the implementation of Patient Aligned Care Teams (PACTs). Improving access to services and care coordination are among the primary goals of PACTs; however, there remain many unanswered questions about how best to use the limited time of PACT team members, such as nurse care managers, to accomplish this. This study will evaluate the effectiveness of a nurse-led telephone support program for Veterans who have been treated recently in the emergency department (ED) and are at high risk for repeat visits. The program's goals are to reduce the need for future ED use and improve satisfaction among Veterans by providing information and support related to the ED visit, enhancing chronic disease management and educating Veterans and family members about PACT and other VA and community services. If proven effective, this program could improve health and healthcare for a large, vulnerable group of Veterans and be cost saving for VHA.

Detailed description: Anticipated Impacts on Veteran's Healthcare More than 1 million Veterans receive care in Emergency Departments (EDs) in VA Medical Centers (VAMCs) annually. ED visits that do not result in hospital admission, commonly referred to as treat and release visits, account for 80% of all VAMC ED encounters. Nearly 1 in 5 Veterans treated and released from a VAMC ED receive additional unscheduled care in the ED or hospital within 30 days, a rate that is higher than non-VA settings. A large number of Veterans and the VA system would benefit from the development of interventions that reduce subsequent ED use in this vulnerable population.

Project Background Failing to address unmet needs and difficulty navigating the health system are two primary forces driving repeat ED use. Unmet needs after an ED visit range from poorly controlled chronic diseases to incomplete understanding of new medications or follow-up instructions. Perceived barriers to access to primary care and other services are also cited as factors that lead Veterans back to the ED for ambulatory care. In a nationally representative sample of 15,263 Veterans with repeat ED visits, the investigators found that 71.7% did not see another VA outpatient provider between their original and return trip to the ED, Improving access to services and care coordination are among the primary goals of the Veterans' Health Administration's (VHA) ongoing reorganization of primary care. Patient Aligned Care Teams (PACTs) are being created in VAMCs across the country; however, there has been little focus on the interface between PACT and the ED. A key role for nurses within PACT will be telephone management of high risk populations, and Veterans treated and released from the ED represent one such high-risk group. However, no studies have examined both the Veteran and system-level impact of using nurse care managers to support Veterans after an ED visit.

Project Objectives

The overall goal of this study is to examine the impact of a primary care-based nurse telephone support program for Veterans treated and released from the ED who are at high risk for repeat visits. The investigators will test the following hypotheses:

H1: Veterans who participate in a primary care-based nurse telephone support program after an ED visit will have fewer ED visits in the subsequent 30 days compared to usual care;

H2: Veterans who participate in a primary care- based nurse telephone support program after an ED visit will have higher satisfaction compared to usual care;

H3: Veterans who participate in a primary care-based nurse telephone support program will have lower VA costs for ED and hospital care in the 180 days following an ED visit, compared to usual care.

Project Methods The proposed study is a two group randomized, controlled trial to evaluate a structured nurse telephone support program for Veterans treated and released from the ED who are at high risk for repeat visits. After informed consent is obtained, Veterans will be randomized to nurse telephone support \[DISPO ED\] or usual care. DISPO ED will consist of 2 calls from a study nurse (simulating the role of a PACT RN Care Manager) within 7 days of the index ED visit, with an option for a 3rd call within 14 days. The primary outcome is a dichotomous outcome defined as any ED use within 30 days or not. Secondary outcomes are patient satisfaction with VA health care at 30 and 180 days, and total VA costs within 180 days.

Eligibility criteria: Inclusion Criteria:

To be included in the study, patients must meet all of the following:

* Treated and released from the Durham VA ED;
* Receive primary care from a Durham VAMC affiliated primary care clinic (at least one visit in a primary care clinic affiliated with the Durham VAMC within the previous 12 months);
* At least one VAMC ED visit or hospital admission within the 6 months preceding the index visit;
* Diagnosed with 2 or more chronic health conditions; and
* Valid telephone number in the medical record; in the investigators' pilot studies, 98.7% of Veterans had a valid phone number in the medical record.

Exclusion Criteria:

Patients will be excluded if they meet any of the following:

* Reside in a nursing home (or other institutional setting);
* Unable to communicate on the telephone, and no proxy available;
* Lacks decision-making capacity, and no proxy available; or
* Returned to ED within 24 hours of discharge from initial visit.
* Have a current Category 1 high-risk suicide flag on their CPRS medical record; or Visit the PEC (Psychiatric Emergency Clinic) within 24 hours of discharge from initial ED visit.
* Enrolled in a study that prohibits cross-enrollment in other studies.

Primary outcomes:
measure: Number of Participants Experiencing Repeat ED Use
timeFrame: 30 days
Secondary outcomes:
measure: Number of Participants Satisfied With Health Care
timeFrame: Baseline
measure: Number of Participants Satisfied With Health Care
timeFrame: 30 days
measure: Number of Participants Satisfied With Health Care
timeFrame: 180 days
measure: Total Costs to the VHA
timeFrame: 180 days
Other outcomes:
Locations:
city: Durham
country: United States
facility: Durham VA Medical Center, Durham, NC
state: North Carolina
Study officials:
affiliation: Durham VA Medical Center, Durham, NC
name: Susan N. Hastings, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hastings SN, Betts E, Schmader KE, Weinberger M, Van Houtven CH, Hendrix CC, Coffman CJ, Stechuchak KM, Weiner M, Morris K, Kessler C, Oddone EZ. Discharge information and support for veterans Receiving Outpatient Care in the Emergency Department: study design and methods. Contemp Clin Trials. 2014 Nov;39(2):342-50. doi: 10.1016/j.cct.2014.10.008. Epub 2014 Nov 3.
citation: Ramos K, Shepherd-Banigan ME, Stechuchak KM, Coffman C, Oddone EZ, Van Houtven C, Hendrix CC, Mahanna EP, Hastings SN. Psychological distress among medically complex veterans with a recent emergency department visit. Psychol Serv. 2022 May;19(2):353-359. doi: 10.1037/ser0000437. Epub 2021 Apr 1.
citation: Hastings SN, Stechuchak KM, Coffman CJ, Mahanna EP, Weinberger M, Van Houtven CH, Schmader KE, Hendrix CC, Kessler C, Hughes JM, Ramos K, Wieland GD, Weiner M, Robinson K, Oddone E. Discharge Information and Support for Patients Discharged from the Emergency Department: Results from a Randomized Controlled Trial. J Gen Intern Med. 2020 Jan;35(1):79-86. doi: 10.1007/s11606-019-05319-6. Epub 2019 Sep 5.