Discharge Information & Support for Patients Receiving Outpatient Care in the ED (DISPO ED)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Department of Veterans Affairs
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01717976
First received: October 26, 2012
Last updated: August 12, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention
Multimorbidity
Behavioral: DISPO ED

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Discharge Information & Support for Patients Receiving Outpatient Care in the ED

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • repeat ED use [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 514
Study Start Date: December 2013
Estimated Study Completion Date: October 2016
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention
primary care based nurse telephone support
Behavioral: DISPO ED
primary care based nurse telephone support
No Intervention: Control
usual care

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, we 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. We 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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 our 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01717976

Contacts
Contact: Susan N Hastings, MD (919) 286-6936 Susan.Hastings@va.gov

Locations
United States, North Carolina
Durham VA Medical Center Recruiting
Durham, North Carolina, United States, 27705
Contact: Susan N Hastings, MD    919-286-6936    Susan.Hastings@va.gov   
Sub-Investigator: Cristina Cu Hendrix, DNSc MSN BSN         
Sub-Investigator: Eugene Z. Oddone, MD MHSc         
Sub-Investigator: Kenneth Schmader, MD         
Sub-Investigator: Morris Weinberger, PhD         
Principal Investigator: Susan N. Hastings, MD         
Sponsors and Collaborators
Investigators
Principal Investigator: Susan N. Hastings, MD VA Medical Center, Durham
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT01717976     History of Changes
Other Study ID Numbers: IIR 12-052
Study First Received: October 26, 2012
Last Updated: August 12, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
emergency department use
veterans

ClinicalTrials.gov processed this record on October 29, 2014