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MultimorbidityDISPO EDNCT01717976

Discharge Information and Support for Patients Receiving Outpatient Care in the Emergency Department

A study testing DISPO ED in people with Multimorbidity, run by VA Office of Research and Development at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Any age
Conditions the study is for
Multimorbidity
What is being tested?
DISPO ED
Could I receive a placebo?
No, everyone receives an active treatment
How many people
513 participants
Where
1 siteUnited States
Study dates
Dec 2013to Nov 2016
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Durham VA Medical Center, Durham, NC

    Durham, North Carolina, 27705

Other trials in United States

About this study

Official title: Discharge Information & Support for Patients Receiving Outpatient Care in the ED

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.

Read the 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.

Conditions
Multimorbidity
Being tested
DISPO ED
Keywords
emergency department use, Veterans

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DISPO EDBehavioural

    primary care based nurse telephone support

Study groups in NCT01717976
Study groupRoleWhat they receive
InterventionExperimentalprimary care based nurse telephone support
Receives: Behavioral: DISPO ED
ControlNo interventionusual care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants Experiencing Repeat ED Use

    Number of Participants Experiencing Repeat ED Use

    Measured: 30 days

Secondary outcomes (4)
  1. Number of Participants Satisfied With Health Care

    Satisfaction with health care determined by 9 or 10 on the CAHPS

    Measured: Baseline

  2. Number of Participants Satisfied With Health Care

    Satisfaction with health care determined by 9 or 10 on the CAHPS

    Measured: 30 days

  3. Number of Participants Satisfied With Health Care

    Satisfaction with health care determined by 9 or 10 on the CAHPS

    Measured: 180 days

  4. Total Costs to the VHA

    Assessment of VA and VA purchased care costs in 2016 dollars within 180 days from emergency department visit

    Measured: 180 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Oct 2012 (estimated)
  2. Study startDec 2013
  3. Primary completionMar 2016
  4. Study completionNov 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
513 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01717976
Sponsor's protocol ID
IIR 12-052
Acronym
DISPO ED
Status last verified
Jun 2017
First submitted
26 Oct 2012
Last updated
25 Jul 2017
Data monitoring committee
No
Individual data sharing
No

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.

    PubMed 25445314
  • Seidenfeld J, Ramos K, Bruening RA, Sperber NR, Stechuchak KM, Hastings SN. Patient experiences of a care transition intervention for Veterans to reduce emergency department visits. Acad Emerg Med. 2023 Apr;30(4):388-397. doi: 10.1111/acem.14661. Epub 2023 Jan 30.

    PubMed 36630213
  • 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.

    PubMed 33793285
  • 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.

    PubMed 31489559

Questions about this trial

What is this clinical trial studying?

A study testing DISPO ED in people with Multimorbidity, run by VA Office of Research and Development at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Experiencing Repeat ED Use (time frame: 30 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01717976, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2017.

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