Effectiveness of a complex regional advance care planning intervention to improve care consistency with care preferences: study protocol for a multi-center, cluster-randomized controlled trial focusing on nursing home residents (BEVOR trial).
ACP facilitation
Advance care planning
Cluster-randomized controlled trial
Complex intervention
Nursing homes
Patient-centered care
Study protocol
Journal
Trials
ISSN: 1745-6215
Titre abrégé: Trials
Pays: England
ID NLM: 101263253
Informations de publication
Date de publication:
12 Sep 2022
12 Sep 2022
Historique:
received:
22
05
2022
accepted:
20
07
2022
entrez:
12
9
2022
pubmed:
13
9
2022
medline:
15
9
2022
Statut:
epublish
Résumé
According to recent legislation, facilitated advance care planning (ACP) for nursing home (NH) residents is covered by German sickness funds. However, the effects of ACP on patient-relevant outcomes have not been studied in Germany yet. This study investigates whether implementing a complex regional ACP intervention improves care consistency with care preferences in NH residents. This is a parallel-group cluster-randomized controlled trial (cRCT) with 48 NHs (≈ 3840 resident beds) between 09/2019 and 02/2023. The intervention group will receive a complex, regional ACP intervention aiming at sustainable systems redesign at all levels (individual, institutional, regional). The intervention comprises comprehensive training of ACP facilitators, implementation of reliable ACP processes, organizational development in the NH and other relevant institutions of the regional healthcare system, and education of health professionals caring for the residents. Control group NHs will deliver care as usual. Primary outcome is the hospitalization rate during the 12-months observation period. Secondary outcomes include the rate of residents whose preferences were known and honored in potentially life-threatening events, hospital days, index treatments like resuscitation and artificial ventilation, advance directives, quality of life, psychological burden on bereaved families, and costs of care. The NHs will provide anonymous, aggregated data of all their residents on the primary outcome and several secondary outcomes (data collection 1). For residents who have given informed consent, we will evaluate care consistency with care preferences and further secondary outcomes, based on chart reviews and short interviews with residents, surrogates, and carers (data collection 2). Process evaluation will aim to explain barriers and facilitators, economic evaluation the cost implications. This study has the potential for high-quality evidence on the effects of a complex regional ACP intervention on NH residents, their families and surrogates, NH staff, and health care utilization in Germany. It is the first cRCT investigating a comprehensive regional ACP intervention that aims at improving patient-relevant clinical outcomes, addressing and educating multiple institutions and health care providers, besides qualification of ACP facilitators. Thereby, it can generate evidence on the potential of ACP to effectively promote patient-centered care in the vulnerable population of frail and often chronically ill elderly. ClinicalTrials.gov ID NCT04333303 . Registered 30 March 2020.
Sections du résumé
BACKGROUND
BACKGROUND
According to recent legislation, facilitated advance care planning (ACP) for nursing home (NH) residents is covered by German sickness funds. However, the effects of ACP on patient-relevant outcomes have not been studied in Germany yet. This study investigates whether implementing a complex regional ACP intervention improves care consistency with care preferences in NH residents.
METHODS
METHODS
This is a parallel-group cluster-randomized controlled trial (cRCT) with 48 NHs (≈ 3840 resident beds) between 09/2019 and 02/2023. The intervention group will receive a complex, regional ACP intervention aiming at sustainable systems redesign at all levels (individual, institutional, regional). The intervention comprises comprehensive training of ACP facilitators, implementation of reliable ACP processes, organizational development in the NH and other relevant institutions of the regional healthcare system, and education of health professionals caring for the residents. Control group NHs will deliver care as usual. Primary outcome is the hospitalization rate during the 12-months observation period. Secondary outcomes include the rate of residents whose preferences were known and honored in potentially life-threatening events, hospital days, index treatments like resuscitation and artificial ventilation, advance directives, quality of life, psychological burden on bereaved families, and costs of care. The NHs will provide anonymous, aggregated data of all their residents on the primary outcome and several secondary outcomes (data collection 1). For residents who have given informed consent, we will evaluate care consistency with care preferences and further secondary outcomes, based on chart reviews and short interviews with residents, surrogates, and carers (data collection 2). Process evaluation will aim to explain barriers and facilitators, economic evaluation the cost implications.
DISCUSSION
CONCLUSIONS
This study has the potential for high-quality evidence on the effects of a complex regional ACP intervention on NH residents, their families and surrogates, NH staff, and health care utilization in Germany. It is the first cRCT investigating a comprehensive regional ACP intervention that aims at improving patient-relevant clinical outcomes, addressing and educating multiple institutions and health care providers, besides qualification of ACP facilitators. Thereby, it can generate evidence on the potential of ACP to effectively promote patient-centered care in the vulnerable population of frail and often chronically ill elderly.
TRIAL REGISTRATION
BACKGROUND
ClinicalTrials.gov ID NCT04333303 . Registered 30 March 2020.
Identifiants
pubmed: 36096948
doi: 10.1186/s13063-022-06576-3
pii: 10.1186/s13063-022-06576-3
pmc: PMC9465132
doi:
Banques de données
ClinicalTrials.gov
['NCT04333303']
Types de publication
Clinical Trial Protocol
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
770Subventions
Organisme : Gemeinsame Bundesausschuss
ID : 01VSF18004
Investigateurs
Annika Albert
(A)
Cornelia Alheid
(C)
Claudia Bausewein
(C)
Manuela Bruene
(M)
Christian Calles
(C)
Havva Camci
(H)
Anne Daubmann
(A)
Sophie Dahlke
(S)
Stephanie Enger
(S)
Berend Feddersen
(B)
Gerd Felder
(G)
Carsten Fluck
(C)
Andreas Freienstein
(A)
Theresa Freytag
(T)
Angela Fuchs
(A)
Andrea Icks
(A)
Jürgen In der Schmitten
(J)
Lena Hensel
(L)
Eva Hummers
(E)
Amra Hot
(A)
Änne Kirchner
(Ä)
Evelyn Kleinert
(E)
Stephanie Klosterhalfen
(S)
Henrike Kolbe
(H)
Sonja Laag
(S)
Henriette Langner
(H)
Susanne Lezius
(S)
Georg Marckmann
(G)
Gabriele Meyer
(G)
Jospeh Montalbo
(J)
Friedemann Nauck
(F)
Thuy Nguyen
(T)
Andre Nowak
(A)
Malte Ossenberg
(M)
Christine Reisinger
(C)
Sophia Reuter
(S)
Nicola Rieder
(N)
Tanja Riester
(T)
Irina Rosu
(I)
Holger Rösgen
(H)
Katharina Salanta
(K)
Zeinep Sassi
(Z)
Jan Schildmann
(J)
Thomas Schulenberg
(T)
Michaela Schunk
(M)
Daniela Sommer
(D)
Henrikje Stanze
(H)
Andreas Stöhr
(A)
Anke Theuerkauf
(A)
Nancy Thilo
(N)
Jessica Tönjann
(J)
Mahnaz Partowinia-Peters
(M)
Sebastian Prommersberger
(S)
Susanne Przybylla
(S)
Christiane Vogel
(C)
Markus Vomhof
(M)
Janka Wilken
(J)
Antonia Zapf
(A)
Jennifer Zimprich
(J)
Informations de copyright
© 2022. The Author(s).
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