- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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
Studieoversikt
Detaljert beskrivelse
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.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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North Carolina
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Durham, North Carolina, Forente stater, 27705
- Durham VA Medical Center, Durham, NC
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Helsetjenesteforskning
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Ingen inngripen: Styre
vanlig omsorg
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Eksperimentell: Intervention
primary care based nurse telephone support
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primary care based nurse telephone support
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Number of Participants Experiencing Repeat ED Use
Tidsramme: 30 days
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Number of Participants Experiencing Repeat ED Use
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30 days
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Number of Participants Satisfied With Health Care
Tidsramme: Baseline
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Satisfaction with health care determined by 9 or 10 on the CAHPS
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Baseline
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Number of Participants Satisfied With Health Care
Tidsramme: 30 days
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Satisfaction with health care determined by 9 or 10 on the CAHPS
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30 days
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Number of Participants Satisfied With Health Care
Tidsramme: 180 days
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Satisfaction with health care determined by 9 or 10 on the CAHPS
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180 days
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Total Costs to the VHA
Tidsramme: 180 days
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Assessment of VA and VA purchased care costs in 2016 dollars within 180 days from emergency department visit
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180 days
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Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Susan N. Hastings, MD, Durham VA Medical Center, Durham, NC
Publikasjoner og nyttige lenker
Generelle publikasjoner
- 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.
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- IIR 12-052
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
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