Abstract

Introduction: Patients are people with different values, opinions and life circumstances. Shared decision making (SDM) involves an approach to the conversation with each patient that places clinical evidence as well as patient preferences centrally in the medical decision making process. Healthcare organizations, e.g., the Danish Multidisciplinary Cancer Group, many Danish hospitals, the Danish Ministry of Health, and the European Cancer Organization prioritize SDM with patients as one of their primary aims. The literature shows that patients generally want to be engaged in decision making about their health to a higher degree than is currently the case and that SDM can facilitate this engagement.

Shared decision making can be supported by a patient decision aid (PtDA), which may be a paperbased tool, a webpage, an app, a video, etc. PtDAs are developed either for the patient to use prior to the consultation (pre-consultation PtDA) or as a tool for the patient and clinician to use together during the consultation (in-consultation PtDA). A number of PtDAs for different diseases have been developed. Many studies, including a Cochrane review with 105 studies, show that the use of a PtDA improves patients’ knowledge, makes them more certain of what matters most to them in the situation, increases their involvement in decision making, and affects the choices made to different degrees. 

The Danish Center for Shared Decision Making (CFFB) has developed a template for an inconsultation PtDA in cooperation with patients, nurses, doctors and designers. The PtDA is named the Decision Helper and may be adjusted to any clinical situation. The Decision Helper is available to all clinicians in Denmark via an online platform.  

Shared decision making is ideal for situations with more than one preference-sensitive option, including that of declining treatment. An invasive diagnostic procedure on a small suspicion of lung cancer and adjuvant treatment after early breast cancer represent such situations. Patients may not be aware that they are in a decision making situation and that their preferences could be of relevance for the decision. For the doctor, such decisions are primarily based on guidelines with little room for individual deviations. 

This thesis seeks to bridge the gap between the standardized guideline-based approach and the patient engaging approach defined as SDM. The hypothesis is that the use of an in-consultation Decision Helper increases patient-reported engagement in the decision making process without adverse effects such as increased patient-reported decisional conflict, fear of cancer recurrence, decision regret and longer consultations. The overall aim of the thesis is to investigate the impact of using an in-consultation Decision Helper on these aspects.

Methods and main results: This thesis contains two quantitative studies and one qualitative study.  

Study I - a prospective cohort study of patients under diagnostic work-up on a small suspicion of lung cancer and operated for early breast cancer, respectively. The aim of the study was to evaluate patient-reported SDM outcomes, consultation length and decisions made when using an in-consultation Decision Helper. The endpoints were patient-reported engagement in the decision making process, decisional conflict, decision regret after six months, consultation length, and distribution of decisions made. The study was conducted simultaneously at the Fast-track Lung Clinic, Department of Internal Medicine and the Breast Cancer Clinic, Department of Oncology, both at Lillebaelt Hospital – University Hospital of Southern Denmark, Vejle, Denmark. The study included patients in a control cohort (N=146) and a SDM cohort (N=115).  

Eighty-two patients from the Fast-track Lung Clinic and 64 patients from the Breast Cancer Clinic were included in the control cohort. Subsequently, the staff at both clinics were trained in SDM and the use of the Decision Helper. Afterwards, 52 patients from the Fast-track Lung Clinic and 63 patients from the Breast Cancer Clinic were included in the SDM cohort. 

Patients in the SDM cohort in the Fast-track Lung Clinic had significantly more reduction in decisional conflict, experienced a higher degree of patient involvement, and felt less regret after six months compared to the control cohort. Patients in the SDM cohort at the Breast Cancer Clinic also had significantly more reduction in decisional conflict and similar benefits on decision regret, although not significantly different from the controls. Patient-reported engagement in the decision making process was high for both cohorts at the Breast Cancer Clinic. At both clinics, the mean consultation time was not significantly longer in the SDM cohort than in the control cohort. At the Breast Cancer Clinic, deselection of adjuvant treatment took place more frequently in the SDM cohort.

Study II - a randomized multicenter trial on patients who had undergone breast conserving surgery for early node-negative breast cancer. The trial was conducted in collaboration with the Danish Breast Cancer Radiotherapy Group (DBCG RT) and named the DBCG RT SDM trial. The aim was to evaluate the effect of SDM supported by a Decision Helper on patient-reported engagement in the decision making process regarding adjuvant whole-breast irradiation compared to usual practice and the potential adverse effects on fear of recurrence, decisional conflict and decision regret.  

Eligible patients were candidates for adjuvant whole-breast irradiation according to the national DBCG guideline. The primary endpoint was patient-reported engagement in the decision making process. Secondary endpoints were oncologist-reported patient engagement in the decision making process, patient-reported decisional conflict, fear of cancer recurrence, knowledge of irradiation, quality of life, and decision regret after six months. Oncologists at four Danish departments of radiotherapy were randomized to practice SDM supported by a Decision Helper (SDM arm) or continue as usual (control arm). The DBCG RT SDM trial included 674 patients (SDM=400, control=274). Patients in the SDM arm reported significantly more engagement in the decision making process and less decisional conflict. No difference in fear of cancer recurrence or decision regret after six months was found between the two arms. Compared to the control arm, the oncologists in the SDM arm reported a significantly higher level of patient engagement. 

Study III - A qualitative study with interviewed oncologists and nurses who participated in the DBCG RT SDM trial. The aim was to investigate and analyze oncologists’ and nurses’ experiences with SDM and the Decision Helper in the context of the DBCG RT SDM trial. The research question was:

 How do the clinicians experience the impact of the Decision Helper on the consultation and on patient involvement? 

Semi-structured interviews were conducted based on an interview guide with mainly open-ended questions covering the foci of the research question. Fourteen oncologists and six nurses from the four departments of radiotherapy were identified by purposeful sampling. The overall findings of the study were related to change and reflected in two main themes:

1) The Decision Helper changed the consultation. Overall, the participants described that the Decision Helper, by its structured, visual design, improved the communication between patient and oncologist. The benefit of the Decision Helper, however, primarily depended on the oncologist’s approach to SDM. Patients’ preferred level of involvement varied.

2) Change of attitude. Participants described an ongoing change towards more patient involvement among Danish oncologists in recent years. The change was described as a shift in the common understanding of “right and wrong decisions” to “the right decision for this patient at this time”. It was reflected in the participants feeling better about decisions that take patients’ preferences into account – also those involving deselection of guidelinerecommended treatment. 

We found that the Decision Helper has potential as a tool for structured, individualized patient engagement in decision making. 

Conclusion: Shared decision making supported by a Decision Helper increases patient engagement in decisions and lowers decisional conflict. No negative consequences of SDM were found. Neither consultation time, decision regret, nor fear of cancer recurrence was increased.
Original languageEnglish
Awarding Institution
  • University of Southern Denmark
Supervisors/Advisors
  • Steffensen, Karina Dahl, Principal supervisor
  • Bechmann, Troels, Supervisor
  • Vrou Offersen, Birgitte, Supervisor, External person
  • Berry, Leonard L, Supervisor, External person
Date of defence24. Nov 2023
Publisher
DOIs
Publication statusPublished - 13. Nov 2023

Note re. dissertation

Print copy of the full thesis is restricted to reference use in the library.

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