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Protocol implementation of Shared Decision Making in Dutch breast cancer care; a prospective process evaluation


- candidate number24145
- NTR NumberNTR5721
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR24-mrt-2016
- Secondary IDs2014-7024 KWf Ad6 shared decision making
- Public TitleProtocol implementation of Shared Decision Making in Dutch breast cancer care; a prospective process evaluation
- Scientific TitleProtocol implementation of Shared Decision Making in Dutch breast cancer care; a prospective process evaluation
- ACRONYM
- hypothesis
- Healt Condition(s) or Problem(s) studiedBreast cancer, Shared decision making
- Inclusion criteriaPatients with newly diagnosed breast cancer, stage I or II who are eligible for breast conserving therapy or mastectomy
- Exclusion criteriaNot understanding the Dutch language
- mec approval receivedno
- multicenter trialno
- randomisedno
- group[default]
- Type[default]
- Studytypeobservational
- planned startdate 1-mei-2016
- planned closingdate1-jan-2017
- Target number of participants150
- InterventionsThe intervention consists of offering patients a personalized patient decision aid.
- Primary outcomeWith respect to our hypotheses on frequency of registering indication for a patient decision aid in the Multidisciplinary Board, for handing out and actually logging in, and assuming that that we can include 150 patients in total (5 hospitals, 30 patients per hospital), we expect that:
- in 120 patients the indication for the decision aid is registered in the Multidisciplinary tumor board, i.e. in 80%, with a 95% CI of 74-86%.
- in 105 patients the personalized decision aid will be handed out, i.e. in 70% with a 95% CI of 63-77%.
- 90 patients will actually log in to the patient decision aid, i.e. 60% with a 95% CI of 53-67%.
- Secondary outcomeEvaluation experiences professionals of applying the Shared Decision Making and the use of the decision aid
- TimepointsAudits and interviews: immediately after implementation Patient questionnaires: during implementation.
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIES W. Savelberg
- CONTACT for SCIENTIFIC QUERIES W. Savelberg
- Sponsor/Initiator Maastricht University Medical Center (MUMC+)
- Funding
(Source(s) of Monetary or Material Support)
KWF Kankerbestrijding
- Publications
- Brief summaryRationale: Practice variations in treatment of early-stage breast cancer should be determined by the preferences of well-informed patients. There is, however, substantial practice variation in type of surgery in breast cancer between Dutch hospitals. Involving patients in the decision making process is seen as an important strategy to reduce unwarranted variation in preference-sensitive care. In an earlier study, we developed a personalized patient decision aid, which was pilot tested in 4 hospitals. Based upon this pilot test, we adapted the implementation strategy. Currently, the decision aid is being implemented in the hospitals in the OncoZON region, and in the hospitals that had participated in the pilot study.

Objectives: The main aim of the current study is to further investigate implementation challenges, by investigating the actual implementation rate at several levels, by investigating barrieres and facilitators for implementation, and by investigating patient-experiences on shared decision making. Study design: This study concerns an observational study, a prospective process evaluation of the implementation of the decision aid.

Study population: Patients with newly diagnosed breast cancer, stage I or II who are eligible for breast conserving therapy or mastectomy can be included. We expect that 5 hospitals will each include 30 patients in a period of 6 months. In addition, in each hospital, all breast surgeons, medical oncologists, radiation oncologists, reconstructive surgeons, nurse practitioners and nurses taking part in the education and decision-making process are invited to participate in implementation of SDM.
- Main changes (audit trail)
- RECORD24-mrt-2016 - 2-mei-2016


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