University of Hamburg, MIN-Faculty, Unit of Health Sciences and Education, Martin-Luther-King-Platz 6, D-20146 Hamburg, Germany; Martin-Luther-University Halle-Wittenberg, Institute for Health and Nursing Science, Magdeburger Str. 8, D-06112 Halle (Saale), Germany.
University of Hamburg, MIN-Faculty, Unit of Health Sciences and Education, Martin-Luther-King-Platz 6, D-20146 Hamburg, Germany.
Int J Nurs Stud. 2019 May;93:141-152. doi: 10.1016/j.ijnurstu.2019.01.013. Epub 2019 Feb 8.
Women with breast cancer demand informed shared decision-making. Guidelines support these claims.
To investigate whether an informed shared decision-making intervention for women with 'ductal carcinoma in situ' comprising an evidence-based decision aid with nurse-led decision coaching enhances the extent of the mutual shared decision-making behavior of patients and professionals regarding treatment options, and to analyze implementation barriers.
Cluster randomized controlled trial with accompanying process evaluation.
Certified breast care centers in Germany.
Women with ductal carcinoma in situ and no previous history of breast cancer facing a primary treatment decision.
Sixteen breast centers were randomized to intervention or standard care to recruit 192 patients (partially-blinded). All coaching sessions and physician consultations were videotaped to assess the primary outcome 'extent of patient involvement in shared decision-making' using the MAPPIN-O observer instrument (scores 0 to 4). Secondary endpoints included the sub-measures of the MAPPIN-inventory (MAPPIN-O, MAPPIN-O, MAPPIN-O, MAPPIN-Q, MAPPIN-Q and MAPPIN-Q), 'informed choice', 'decisional conflict' and 'duration of consultations'. Primary intention-to-treat analyses were on cluster level comparing means of cluster values using t-tests. An accompanying process evaluation was conducted comprising 1) analysis of all video recordings with focus on procedures and intervention fidelity and 2) field notes of researchers and feedback from professionals and patients assessed by questionnaires and interviews with focus on barriers and facilitators for implementation at different time points.
Due to protracted recruitment, the study was terminated after 14 centers had included 64 patients (intervention group 36, control group 28). Patient participation in informed shared decision-making was significantly higher in the intervention group (mean (SD) score 2.29 (0.56) vs. 0.42 (0.51) in the control group; difference 1.88 (95% CI 1.26-2.50, p < 0.0001). 47.7% women in the intervention group made informed choices, but none in the control group, difference 47.7% (95% CI 12.6-82.7%, p = 0.016). In the intervention group physician consultations lasted 12.8 (6.6) min. vs. 24.3 (6.3) min. in the control group. Physicians' attitudes, false incentives and structural barriers hindered implementation of informed shared decision-making. Nurses appreciated their new roles.
Informed shared decision-making is not yet implemented in German breast care centers. Nurse-led decision coaching grounded on evidence-based patient information enhances informed shared decision-making. Trial registration No. ISRCTN46305518.
患有乳腺癌的女性需要知情的共同决策。指南支持这些主张。
调查针对患有“导管原位癌”的女性的知情共同决策干预措施，该措施包括基于证据的决策辅助工具和护士主导的决策辅导，是否可以增强患者和专业人员对治疗选择的共同决策行为的程度，并分析实施障碍。
具有伴随过程评估的聚类随机对照试验。
德国认证的乳房护理中心。
患有导管原位癌且无乳腺癌既往病史的女性，面临原发性治疗决策。
将 16 个乳房中心随机分为干预组或标准护理组，以招募 192 名患者（部分盲法）。所有辅导课程和医生咨询均进行了录像，以使用 MAPPIN-O 观察员工具（评分 0 到 4）评估主要结局“患者参与共同决策的程度”。次要终点包括 MAPPIN 清单的子量表（MAPPIN-O、MAPPIN-O、MAPPIN-O、MAPPIN-Q、MAPPIN-Q 和 MAPPIN-Q）、“知情选择”、“决策冲突”和“咨询时间”。主要意向治疗分析在集群水平上比较集群值的平均值，使用 t 检验。进行了伴随的过程评估，包括 1）对所有录像进行分析，重点是程序和干预保真度，以及 2）研究人员的现场记录以及专业人员和患者的反馈，通过问卷和重点是不同时间点实施障碍和促进因素的访谈进行评估。
由于招募时间延长，该研究在 14 个中心纳入 64 名患者（干预组 36 名，对照组 28 名）后终止。干预组患者参与知情共同决策的程度明显高于对照组（干预组平均（SD）得分 2.29（0.56），对照组 0.42（0.51）；差异 1.88（95%CI 1.26-2.50，p < 0.0001）。干预组 47.7%的女性做出了知情选择，但对照组没有，差异 47.7%（95%CI 12.6-82.7%，p = 0.016）。干预组的医生咨询时间为 12.8（6.6）分钟，而对照组为 24.3（6.3）分钟。医生的态度、虚假激励和结构性障碍阻碍了知情共同决策的实施。护士对他们的新角色表示赞赏。
德国乳房护理中心尚未实施知情共同决策。基于证据的患者信息的护士主导的决策辅导可增强知情共同决策。试验注册号 ISRCTN46305518。
