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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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
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 group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | primary care based nurse telephone support Receives: Behavioral: DISPO ED |
| Control | No intervention | usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Experiencing Repeat ED Use
Number of Participants Experiencing Repeat ED Use
Measured: 30 days
Secondary outcomes (4)
Number of Participants Satisfied With Health Care
Satisfaction with health care determined by 9 or 10 on the CAHPS
Measured: Baseline
Number of Participants Satisfied With Health Care
Satisfaction with health care determined by 9 or 10 on the CAHPS
Measured: 30 days
Number of Participants Satisfied With Health Care
Satisfaction with health care determined by 9 or 10 on the CAHPS
Measured: 180 days
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.
- First posted31 Oct 2012 (estimated)
- Study startDec 2013
- Primary completionMar 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for MultimorbidityStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Susan N. Hastings, MD, Principal investigator, Durham VA Medical Center, Durham, NC
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
- Results posted
- Yes, on ClinicalTrials.gov
- 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 25445314Seidenfeld 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 36630213Ramos 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 33793285Hastings 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
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Discharge Information & Support for Patients Receiving Outpatient Care in the ED
- ClinicalTrials.gov ID
- NCT01717976
- Acronym / sponsor ID
- DISPO ED / IIR 12-052
- Conditions
- Multimorbidity
- Keywords
- emergency department use, Veterans
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 513 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- Dec 2013
- Primary completion
- Mar 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 31 Oct 2012 (estimated)
- Results
- Posted 16 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: DISPO EDprimary care based nurse telephone support |
| Control | No intervention | –usual care |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DISPO EDprimary care based nurse telephone support | Behavioural | Intervention |
Primary outcome
Number of Participants Experiencing Repeat ED Use
Time frame: 30 days
Number of Participants Experiencing Repeat ED Use
4 secondary outcomes
Number of Participants Satisfied With Health Care
Time frame: Baseline
Number of Participants Satisfied With Health Care
Time frame: 30 days
Number of Participants Satisfied With Health Care
Time frame: 180 days
Total Costs to the VHA
Time frame: 180 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 25445314Hastings 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.
- Derived from this study: PubMed 36630213Seidenfeld 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.
- Derived from this study: PubMed 33793285Ramos 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.
- Derived from this study: PubMed 31489559Hastings 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan N. Hastings, MD principal investigator
Durham VA Medical Center, Durham, NC
1 site in 1 country: see every site and its status.
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.