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)

  1. Götze, Kornelia ORCID logo
  2. Montalbo, Joseph
  3. Wegscheider, Karl
  4. Albert, Annika
  5. Alheid, Cornelia
  6. Bausewein, Claudia
  7. Bruene, Manuela
  8. Calles, Christian
  9. Camci, Havva
  10. Daubmann, Anne
  11. Dahlke, Sophie
  12. Enger, Stephanie
  13. Feddersen, Berend
  14. Felder, Gerd
  15. Fluck, Carsten
  16. Freienstein, Andreas
  17. Freytag, Theresa
  18. Fuchs, Angela
  19. Icks, Andrea
  20. in der Schmitten, Jürgen
  21. Hensel, Lena
  22. Hummers, Eva
  23. Hot, Amra
  24. Kirchner, Änne
  25. Kleinert, Evelyn
  26. Klosterhalfen, Stephanie
  27. Kolbe, Henrike
  28. Laag, Sonja
  29. Langner, Henriette
  30. Lezius, Susanne
  31. Marckmann, Georg
  32. Meyer, Gabriele
  33. Montalbo, Jospeh
  34. Nauck, Friedemann
  35. Nguyen, Thuy
  36. Nowak, Andre
  37. Ossenberg, Malte
  38. Reisinger, Christine
  39. Reuter, Sophia
  40. Rieder, Nicola
  41. Riester, Tanja
  42. Rosu, Irina
  43. Rösgen, Holger
  44. Salanta, Katharina
  45. Sassi, Zeinep
  46. Schildmann, Jan
  47. Schulenberg, Thomas
  48. Schunk, Michaela
  49. Sommer, Daniela
  50. Stanze, Henrikje
  51. Stöhr, Andreas
  52. Theuerkauf, Anke
  53. Thilo, Nancy
  54. Tönjann, Jessica
  55. Partowinia-Peters, Mahnaz
  56. Prommersberger, Sebastian
  57. Przybylla, Susanne
  58. Vogel, Christiane
  59. Vomhof, Markus
  60. Wilken, Janka
  61. Zapf, Antonia
  62. Zimprich, Jennifer

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1000 Titel
  • 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)
1000 Autor/in
  1. Götze, Kornelia |
  2. Montalbo, Joseph |
  3. Wegscheider, Karl |
  4. Albert, Annika |
  5. Alheid, Cornelia |
  6. Bausewein, Claudia |
  7. Bruene, Manuela |
  8. Calles, Christian |
  9. Camci, Havva |
  10. Daubmann, Anne |
  11. Dahlke, Sophie |
  12. Enger, Stephanie |
  13. Feddersen, Berend |
  14. Felder, Gerd |
  15. Fluck, Carsten |
  16. Freienstein, Andreas |
  17. Freytag, Theresa |
  18. Fuchs, Angela |
  19. Icks, Andrea |
  20. in der Schmitten, Jürgen |
  21. Hensel, Lena |
  22. Hummers, Eva |
  23. Hot, Amra |
  24. Kirchner, Änne |
  25. Kleinert, Evelyn |
  26. Klosterhalfen, Stephanie |
  27. Kolbe, Henrike |
  28. Laag, Sonja |
  29. Langner, Henriette |
  30. Lezius, Susanne |
  31. Marckmann, Georg |
  32. Meyer, Gabriele |
  33. Montalbo, Jospeh |
  34. Nauck, Friedemann |
  35. Nguyen, Thuy |
  36. Nowak, Andre |
  37. Ossenberg, Malte |
  38. Reisinger, Christine |
  39. Reuter, Sophia |
  40. Rieder, Nicola |
  41. Riester, Tanja |
  42. Rosu, Irina |
  43. Rösgen, Holger |
  44. Salanta, Katharina |
  45. Sassi, Zeinep |
  46. Schildmann, Jan |
  47. Schulenberg, Thomas |
  48. Schunk, Michaela |
  49. Sommer, Daniela |
  50. Stanze, Henrikje |
  51. Stöhr, Andreas |
  52. Theuerkauf, Anke |
  53. Thilo, Nancy |
  54. Tönjann, Jessica |
  55. Partowinia-Peters, Mahnaz |
  56. Prommersberger, Sebastian |
  57. Przybylla, Susanne |
  58. Vogel, Christiane |
  59. Vomhof, Markus |
  60. Wilken, Janka |
  61. Zapf, Antonia |
  62. Zimprich, Jennifer |
1000 Verlag
  • BioMed Central
1000 Erscheinungsjahr 2022
1000 Publikationstyp
  1. Artikel |
1000 Online veröffentlicht
  • 2022-09-12
1000 Erschienen in
1000 Quellenangabe
  • 23(1):770
1000 Copyrightjahr
  • 2022
1000 Lizenz
1000 Verlagsversion
  • https://doi.org/10.1186/s13063-022-06576-3 |
  • https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9465132/ |
1000 Publikationsstatus
1000 Begutachtungsstatus
1000 Sprache der Publikation
1000 Abstract/Summary
  • <jats:title>Abstract</jats:title><jats:sec> <jats:title>Background</jats:title> <jats:p>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.</jats:p> </jats:sec><jats:sec> <jats:title>Methods</jats:title> <jats:p>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.</jats:p> <jats:p>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.</jats:p> <jats:p>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.</jats:p> </jats:sec><jats:sec> <jats:title>Discussion</jats:title> <jats:p>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.</jats:p> </jats:sec><jats:sec> <jats:title>Trial registration</jats:title> <jats:p><jats:ext-link xmlns:xlink='http://www.w3.org/1999/xlink' ext-link-type='uri' xlink:href='http://clinicaltrials.gov'>ClinicalTrials.gov</jats:ext-link> ID NCT04333303. Registered 30 March 2020.</jats:p> </jats:sec>
1000 Sacherschließung
lokal Aged [MeSH]
lokal Study Protocol
lokal Humans [MeSH]
lokal Complex intervention
lokal Advance Care Planning [MeSH]
lokal Multicenter Studies as Topic [MeSH]
lokal Nursing Homes [MeSH]
lokal Study protocol
lokal Randomized Controlled Trials as Topic [MeSH]
lokal Medical and Health Sciences
lokal Quality of Life [MeSH]
lokal ACP facilitation
lokal Germany [MeSH]
lokal Patient-centered care
lokal Nursing homes
lokal Cluster-randomized controlled trial
lokal Advance care planning
lokal Health Personnel [MeSH]
1000 Liste der Beteiligten
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