- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00234286
Intervention to Improve Care at Life's End (BEACON)
Intervention to Improve Care at Life's End in VA Medical Centers
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
The BEACON trial (Best Practices for End-of-Life Care for Our Nations' Veterans) was a six-site, real-world implementation trial of a multi-component, education-based intervention to improve the quality of end-of-life care conducted in VA Medical Centers (VAMCs).
The primary aim was to evaluate the effectiveness of a multi-component intervention for improving processes of care provided in the last days of life in VAMCs. The second aim was to conduct after-death interviews with next-of-kin and qualitative analysis of their perceptions of the care provided to the veteran and family.
The multi-component intervention targeted VAMC inpatient providers, including physician, nursing, and ancillary staff. It consisted of preparatory site visits, a staff training program, a newly developed Comfort Care order set decision support tool built into the CPRS, and follow-up consultation. The intervention team travelled to each site to conduct two weeks of comprehensive in-service training. Staff were trained to identify actively-dying patients and implement a set of best practices of traditionally home-based hospice care for dying patients. The team provided assistance with policies, procedures, and skill training needed to implement comfort care interventions. Introduction of the intervention at each VAMC was staggered across time at six-month intervals using a multiple-baseline, stepped wedge design.
Data on processes of end-of-life care (last 7 days) were abstracted from the CPRS medical records of all veterans who died before, during, and after the intervention (January 2005-February 2011). A priori, five processes of care were identified as primary endpoints to indicate quality of end-of-life care: 1) presence of an order for opioid pain medication at time of death; 2) a do-not-resuscitate (DNR) order in place at time of death; 3) location of death; 4) presence of enteral feeding tube or intravenous line at time of death; and 5) physical restraints in place at or near time of death.
In addition, in-depth, face-to-face interviews were conducted with 78 bereaved next-of-kin.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
Alabama
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Birmingham, Alabama, Forente stater, 35233
- Birmingham VA Medical Center
-
-
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:
- Aim 1: Not applicable. Patients were deceased.
- Aim 2: After-death interviews with next of kin: must be willing and able to participate in after-death interview at local VA Medical Center.
Exclusion Criteria:
- N/A
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Helsetjenesteforskning
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: Arm 1
Comfort care education intervention, consisting of intensive, on-site staff training together with an electronic order set for palliative care and educational materials
|
Comfort care education intervention, consisting of intensive, on-site staff training together with an electronic order set for palliative care and educational materials
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Presence of Order for Opioid Pain Medication
Tidsramme: Pre and Post Intervention
|
Presence of order for opioid pain medication at time of death based on abstraction of electronic medical record
|
Pre and Post Intervention
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Do Not Resuscitate Order
Tidsramme: Pre and Post Intervention
|
Presence of a Do Not Resuscitate order at time of death based on abstraction of electronic medical record
|
Pre and Post Intervention
|
Number of Patients Who Died in ICU
Tidsramme: Pre and Post Intervention
|
Location of death (ICU vs. other) based on abstraction of electronic medical record
|
Pre and Post Intervention
|
Individuals With a Nasogastric Tube
Tidsramme: Pre and Post Intervention
|
Presence of nasogastric tube based on abstraction of electronic medical record
|
Pre and Post Intervention
|
Individuals With an Intravenous Line
Tidsramme: Pre and Post Intervention
|
Presence of intravenous line infusing at time of death based on abstraction of electronic medical record
|
Pre and Post Intervention
|
Number of Individuals Who Died in Restraints
Tidsramme: Pre and Post Intervention
|
Presence of restraints at or near time of death at time of death based on abstraction of electronic medical record
|
Pre and Post Intervention
|
Individuals Administered of Opioid Medication
Tidsramme: Pre and Post Intervention
|
Administration of opioid medication based on abstraction of medical record
|
Pre and Post Intervention
|
Individuals With an Order for Antipsychotic Medication
Tidsramme: Pre and Post Intervention
|
Order for antipsychotic medication based on abstraction of medical record
|
Pre and Post Intervention
|
Individuals Administered Antipsychotic Medication
Tidsramme: Pre and Post Intervention
|
Administration of antipsychotic medication based on abstraction of medical record
|
Pre and Post Intervention
|
Individuals With an Order for Benzodiazepine Medication
Tidsramme: Pre and Post Intervention
|
Order for benzodiazepine medication based on abstraction of medical record
|
Pre and Post Intervention
|
Individuals Who Received Benzodiazepine Medication
Tidsramme: Pre and Post Intervention
|
Administration of benzodiazepine medication based on abstraction of medical record
|
Pre and Post Intervention
|
Individuals Who Received Scopolamine
Tidsramme: Pre and Post Intervention
|
Administration of scopolamine (for death rattle) based on abstraction of medical record
|
Pre and Post Intervention
|
Sublingual Administration
Tidsramme: Pre and Post Intervention
|
Sublingual administration of medication based on abstraction of medical record
|
Pre and Post Intervention
|
Individuals With Pastoral Care Visit
Tidsramme: Pre and Post Intervention
|
Pastoral Care Visit based on abstraction of medical record
|
Pre and Post Intervention
|
Individuals With an Advance Directive
Tidsramme: Pre and Post Intervention
|
Presence of advance directive based on abstraction of medical record
|
Pre and Post Intervention
|
Individuals With a Palliative Care Consultation
Tidsramme: Pre and Post Intervention
|
Palliative Care Consultation based on abstraction of medical record
|
Pre and Post Intervention
|
Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Kathryn L Burgio, PhD MA BA, Birmingham, Alabama VA Medical Center
Publikasjoner og nyttige lenker
Generelle publikasjoner
- Williams BR, Woodby LL, Bailey FA, Burgio KL. Identifying and responding to ethical and methodological issues in after-death interviews with next-of-kin. Death Stud. 2008;32(3):197-236. doi: 10.1080/07481180701881297.
- Woodby LL, Williams BR, Wittich AR, Burgio KL. Expanding the notion of researcher distress: the cumulative effects of coding. Qual Health Res. 2011 Jun;21(6):830-8. doi: 10.1177/1049732311402095. Epub 2011 Mar 10.
- Bailey FA, Williams BR, Goode PS, Woodby LL, Redden DT, Johnson TM 2nd, Taylor JW, Burgio KL. Opioid pain medication orders and administration in the last days of life. J Pain Symptom Manage. 2012 Nov;44(5):681-91. doi: 10.1016/j.jpainsymman.2011.11.006. Epub 2012 Jul 4.
- Bailey FA, Allen RS, Williams BR, Goode PS, Granstaff S, Redden DT, Burgio KL. Do-not-resuscitate orders in the last days of life. J Palliat Med. 2012 Jul;15(7):751-9. doi: 10.1089/jpm.2011.0321. Epub 2012 Apr 26.
- Bickel KE, Kennedy R, Levy C, Burgio KL, Bailey FA. The Relationship of Post-traumatic Stress Disorder to End-of-life Care Received by Dying Veterans: a Secondary Data Analysis. J Gen Intern Med. 2020 Feb;35(2):505-513. doi: 10.1007/s11606-019-05538-x. Epub 2019 Dec 2.
- Riggs JS, Woodby LL, Burgio KL, Bailey FA, Williams BR. "Don't get weak in your compassion": bereaved next of kin's suggestions for improving end-of-life care in Veterans Affairs Medical Centers. J Am Geriatr Soc. 2014 Apr;62(4):642-8. doi: 10.1111/jgs.12764. Epub 2014 Mar 21.
- Bailey FA, Williams BR, Woodby LL, Goode PS, Redden DT, Houston TK, Granstaff US, Johnson TM 2nd, Pennypacker LC, Haddock KS, Painter JM, Spencer JM, Hartney T, Burgio KL. Intervention to improve care at life's end in inpatient settings: the BEACON trial. J Gen Intern Med. 2014 Jun;29(6):836-43. doi: 10.1007/s11606-013-2724-6.
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 (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- IIR 03-126
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