Display options
Cite
Scholl I, Hahlweg P, Lindig A, et al. Evaluation of a program for routine implementation of shared decision-making in cancer care: results of a stepped wedge cluster randomized trial. Implement Sci. 2021;16(1):106doi: 10.1186/s13012-021-01174-4.
Scholl, I., Hahlweg, P., Lindig, A., Frerichs, W., Zill, J., Cords, H., Bokemeyer, C., Coym, A., Schmalfeldt, B., Smeets, R., Vollkommer, T., Witzel, I., Härter, M., & Kriston, L. (2021). Evaluation of a program for routine implementation of shared decision-making in cancer care: results of a stepped wedge cluster randomized trial. Implementation science : IS, 16(1), 106. https://doi.org/10.1186/s13012-021-01174-4
Scholl, Isabelle, et al. "Evaluation of a program for routine implementation of shared decision-making in cancer care: results of a stepped wedge cluster randomized trial." Implementation science : IS vol. 16,1 (2021): 106. doi: https://doi.org/10.1186/s13012-021-01174-4
Scholl I, Hahlweg P, Lindig A, Frerichs W, Zill J, Cords H, Bokemeyer C, Coym A, Schmalfeldt B, Smeets R, Vollkommer T, Witzel I, Härter M, Kriston L. Evaluation of a program for routine implementation of shared decision-making in cancer care: results of a stepped wedge cluster randomized trial. Implement Sci. 2021 Dec 29;16(1):106. doi: 10.1186/s13012-021-01174-4. PMID: 34965881; PMCID: PMC8715412.
Copy Download .nbib Format: NLM
Share it on

Implement Sci. 2021 Dec 29;16(1):106. doi: 10.1186/s13012-021-01174-4.

Evaluation of a program for routine implementation of shared decision-making in cancer care: results of a stepped wedge cluster randomized trial.

Implementation science : IS

Isabelle Scholl, Pola Hahlweg, Anja Lindig, Wiebke Frerichs, Jördis Zill, Hannah Cords, Carsten Bokemeyer, Anja Coym, Barbara Schmalfeldt, Ralf Smeets, Tobias Vollkommer, Isabell Witzel, Martin Härter, Levente Kriston

Affiliations

  1. Department of Medical Psychology, University Medical Center Hamburg-Eppendorf, Martinistrasse 52, 20246, Hamburg, Germany. [email protected].
  2. Department of Medical Psychology, University Medical Center Hamburg-Eppendorf, Martinistrasse 52, 20246, Hamburg, Germany.
  3. II. Department of Medicine, University Medical Center Hamburg-Eppendorf, Martinistrasse 52, 20246, Hamburg, Germany.
  4. Department of Gynecology, University Medical Center Hamburg-Eppendorf, Martinistrasse 52, 20246, Hamburg, Germany.
  5. Department of Oral and Maxillofacial Surgery, University Medical Center Hamburg-Eppendorf, Martinistrasse 52, 20246, Hamburg, Germany.

PMID: 34965881 PMCID: PMC8715412 DOI: 10.1186/s13012-021-01174-4

Abstract

BACKGROUND: Shared decision-making (SDM) is preferred by many patients in cancer care. However, despite scientific evidence and promotion by health policy makers, SDM implementation in routine health care lags behind. This study aimed to evaluate an empirically and theoretically grounded implementation program for SDM in cancer care.

METHODS: In a stepped wedge design, three departments of a comprehensive cancer center sequentially received the implementation program in a randomized order. It included six components: training for health care professionals (HCPs), individual coaching for physicians, patient activation intervention, patient information material/decision aids, revision of quality management documents, and reflection on multidisciplinary team meetings (MDTMs). Outcome evaluation comprised four measurement waves. The primary endpoint was patient-reported SDM uptake using the 9-item Shared Decision Making Questionnaire. Several secondary implementation outcomes were assessed. A mixed-methods process evaluation was conducted to evaluate reach and fidelity. Data were analyzed using mixed linear models, qualitative content analysis, and descriptive statistics.

RESULTS: A total of 2,128 patient questionnaires, 559 questionnaires from 408 HCPs, 132 audio recordings of clinical encounters, and 842 case discussions from 66 MDTMs were evaluated. There was no statistically significant improvement in the primary endpoint SDM uptake. Patients in the intervention condition were more likely to experience shared or patient-lead decision-making than in the control condition (d=0.24). HCPs in the intervention condition reported more knowledge about SDM than in the control condition (d = 0.50). In MDTMs the quality of psycho-social information was lower in the intervention than in the control condition (d = - 0.48). Further secondary outcomes did not differ statistically significantly between conditions. All components were implemented in all departments, but reach was limited (e.g., training of 44% of eligible HCPs) and several adaptations occurred (e.g., reduced dose of coaching).

CONCLUSIONS: The process evaluation provides possible explanations for the lack of statistically significant effects in the primary and most of the secondary outcomes. Low reach and adaptations, particularly in dose, may explain the results. Other or more intensive approaches are needed for successful department-wide implementation of SDM in routine cancer care. Further research is needed to understand factors influencing implementation of SDM in cancer care.

TRIAL REGISTRATION: clinicaltrials.gov, NCT03393351 , registered 8 January 2018.

© 2021. The Author(s).

Keywords: Cancer; Cluster randomized controlled trial; Health services research; Implementation science; Outcome evaluation; Process evaluation; Shared decision-making; Stepped wedge design

References

  1. Z Evid Fortbild Qual Gesundhwes. 2017 Jun;123-124:46-51 - PubMed
  2. Soc Sci Med. 1997 Mar;44(5):681-92 - PubMed
  3. JAMA Oncol. 2015 Apr;1(1):50-8 - PubMed
  4. BMJ. 2017 Nov 6;359:j4891 - PubMed
  5. Implement Sci. 2009 Aug 07;4:50 - PubMed
  6. PLoS One. 2016 Mar 11;11(3):e0149789 - PubMed
  7. BMJ. 2017 Apr 18;357:j1744 - PubMed
  8. JAMA. 2014 Oct 1;312(13):1295-6 - PubMed
  9. Patient Educ Couns. 2012 Jan;86(1):9-18 - PubMed
  10. BMC Health Serv Res. 2018 Jan 31;18(1):74 - PubMed
  11. Patient Educ Couns. 2006 Mar;60(3):301-12 - PubMed
  12. Stat Med. 2000 Nov 30;19(22):3127-31 - PubMed
  13. Health Expect. 2020 Oct;23(5):1310-1325 - PubMed
  14. Can J Nurs Res. 1997 Fall;29(3):21-43 - PubMed
  15. Implement Sci. 2020 Sep 21;15(1):81 - PubMed
  16. Adm Policy Ment Health. 2012 Sep;39(5):331-40 - PubMed
  17. BJS Open. 2021 Mar 5;5(2): - PubMed
  18. Patient Educ Couns. 2011 Sep;84(3):379-85 - PubMed
  19. Health Aff (Millwood). 2016 Apr;35(4):630-6 - PubMed
  20. BMC Cancer. 2017 Nov 17;17(1):772 - PubMed
  21. Oncol Res Treat. 2020;43(6):307-313 - PubMed
  22. Patient Educ Couns. 2010 Jul;80(1):94-9 - PubMed
  23. Implement Sci. 2017 Oct 10;12(1):119 - PubMed
  24. Stat Methods Med Res. 2021 Feb;30(2):612-639 - PubMed
  25. J Med Internet Res. 2014 Jan 03;16(1):e2 - PubMed
  26. Stat Biopharm Res. 2020 Jul 6;12(4):399-411 - PubMed
  27. BMC Health Serv Res. 2021 Jun 2;21(1):541 - PubMed
  28. Acta Oncol. 2016 Dec;55(12):1484-1491 - PubMed
  29. Implement Sci. 2015 Apr 21;10:53 - PubMed
  30. Ann Oncol. 2010 Jun;21(6):1145-1151 - PubMed
  31. J Gen Intern Med. 1990 Jan-Feb;5(1):29-33 - PubMed
  32. N Engl J Med. 2012 Mar 1;366(9):780-1 - PubMed
  33. Milbank Q. 2007;85(1):93-138 - PubMed
  34. BMC Med Inform Decis Mak. 2013;13 Suppl 2:S14 - PubMed
  35. Patient Educ Couns. 2013 Nov;93(2):265-71 - PubMed
  36. Implement Sci. 2018 Mar 9;13(1):40 - PubMed
  37. Contemp Clin Trials. 2007 Feb;28(2):182-91 - PubMed
  38. Implement Sci. 2013 Dec 01;8:139 - PubMed
  39. Z Evid Fortbild Qual Gesundhwes. 2017 Jun;123-124:1-5 - PubMed
  40. Acta Oncol. 2016;55(2):134-9 - PubMed
  41. BMJ Open. 2019 Jun 21;9(6):e026488 - PubMed
  42. BMC Med Res Methodol. 2020 Aug 12;20(1):208 - PubMed
  43. Med Care. 2012 Mar;50(3):217-26 - PubMed
  44. Implement Sci. 2014 Jan 10;9:7 - PubMed
  45. J Allergy Clin Immunol Pract. 2020 Sep;8(8):2474-2480.e1 - PubMed
  46. Support Care Cancer. 2017 Sep;25(9):2753-2760 - PubMed
  47. BMJ. 2017 Mar 6;356:i6795 - PubMed
  48. Ann Surg Oncol. 2013 Mar;20(3):715-22 - PubMed
  49. Ann Intern Med. 2020 Jan 7;172(1):35-45 - PubMed
  50. Patient Educ Couns. 2016 May;99(5):739-46 - PubMed
  51. BMJ. 1998 Jan 31;316(7128):361-5 - PubMed
  52. BMJ. 2011 Mar 22;342:d1745 - PubMed
  53. Patient Educ Couns. 2013 Oct;93(1):102-7 - PubMed
  54. Adm Policy Ment Health. 2011 Mar;38(2):65-76 - PubMed
  55. Oncologist. 2012;17(1):91-100 - PubMed
  56. PLoS One. 2015 Oct 06;10(10):e0139921 - PubMed
  57. Implement Sci. 2018 Mar 27;13(1):51 - PubMed
  58. BMJ. 2012 Nov 08;345:e6572 - PubMed
  59. Cochrane Database Syst Rev. 2017 Apr 12;4:CD001431 - PubMed
  60. BMJ Open. 2020 Oct 10;10(10):e037575 - PubMed
  61. Eur J Cancer. 1997 Jul;33(8):1184-9 - PubMed
  62. Acta Oncol. 2020 Aug;59(8):967-974 - PubMed
  63. BMJ Open. 2020 Jun 7;10(6):e034380 - PubMed
  64. Patient Educ Couns. 2015 Aug;98(8):970-6 - PubMed
  65. BMJ Open. 2017 Sep 27;7(9):e016360 - PubMed
  66. BMJ. 2018 Nov 9;363:k1614 - PubMed
  67. Med Decis Making. 2003 Jul-Aug;23(4):275-80 - PubMed

Publication Types

Grant support