- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01717976
Discharge Information and Support for Patients Receiving Outpatient Care in the Emergency Department (DISPO ED)
Discharge Information & Support for Patients Receiving Outpatient Care in the ED
Study Overview
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
North Carolina
-
Durham, North Carolina, United States, 27705
- Durham VA Medical Center, Durham, NC
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control
usual care
|
|
Experimental: Intervention
primary care based nurse telephone support
|
primary care based nurse telephone support
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants Experiencing Repeat ED Use
Time Frame: 30 days
|
Number of Participants Experiencing Repeat ED Use
|
30 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants Satisfied With Health Care
Time Frame: Baseline
|
Satisfaction with health care determined by 9 or 10 on the CAHPS
|
Baseline
|
Number of Participants Satisfied With Health Care
Time Frame: 30 days
|
Satisfaction with health care determined by 9 or 10 on the CAHPS
|
30 days
|
Number of Participants Satisfied With Health Care
Time Frame: 180 days
|
Satisfaction with health care determined by 9 or 10 on the CAHPS
|
180 days
|
Total Costs to the VHA
Time Frame: 180 days
|
Assessment of VA and VA purchased care costs in 2016 dollars within 180 days from emergency department visit
|
180 days
|
Collaborators and Investigators
Investigators
- Principal Investigator: Susan N. Hastings, MD, Durham VA Medical Center, Durham, NC
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- IIR 12-052
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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.
Clinical Trials on Multimorbidity
-
Malin Olsen SyversenOslo University Hospital; Oslo University CollegeRecruiting
-
Hospital Galdakao-UsansoloHospital del Mar; Instituto de Salud Carlos III; Hospitales Universitarios Virgen... and other collaboratorsCompleted
-
Dartmouth-Hitchcock Medical CenterNational Library of Medicine (NLM)CompletedMultimorbidityUnited States
-
Central Jutland Regional HospitalCompleted
-
McMaster UniversityCompleted
-
Slagelse HospitalUniversity of CopenhagenRecruiting
-
VA Office of Research and DevelopmentVeterans Health Administration Office of Primary Care; Veterans Health Administration... and other collaboratorsRecruiting
-
Gerencia de Atención Primaria, MadridFundació d'investigació Sanitària de les Illes Balears; Institut Català de... and other collaboratorsEnrolling by invitation
-
University of BernUniversity of Zurich; Swiss National Science Foundation; University of Basel; Utrecht...CompletedMultimorbidity | PolypharmacySwitzerland
-
Royal College of Surgeons, IrelandUniversity of Dublin, Trinity College; Health Service Executive, IrelandCompletedMultimorbidity | PolypharmacyIreland
Clinical Trials on DISPO ED
-
University of PennsylvaniaCompletedObesityUnited States
-
University Health Network, TorontoCompletedEating Disorder | PostTraumatic Stress DisorderCanada
-
Northwell HealthNational Institute on Aging (NIA)Active, not recruiting
-
Brigham and Women's HospitalRecruitingChronic Obstructive Pulmonary Disease | Metastatic Cancer | Congestive Heart Failure | Chronic Kidney Disease Requiring Chronic DialysisUnited States
-
VA Office of Research and DevelopmentActive, not recruitingBenzodiazepine Dependence | Taking Benzodiazepines for Any Reason for 3 MonthsUnited States
-
National Jewish HealthNational Heart, Lung, and Blood Institute (NHLBI); The Miriam Hospital; National...CompletedSleep Apnea, Obstructive | Continuous Positive Airway PressureUnited States
-
Ottawa Hospital Research InstituteSuspendedAcute Leukemia | Myelodysplastic SyndromeCanada
-
Vanderbilt University Medical CenterRecruiting
-
University of LouisvilleDepartment of Health and Human ServicesCompletedSexually Transmitted Diseases | PregnancyUnited States