Carroll Sandra L, Stacey Dawn, McGillion Michael, Healey Jeff S, Foster Gary, Hutchings Sarah, Arthur Heather M, Browne Gina, Thabane Lehana
Faculty of Health Sciences, School of Nursing, McMaster University, 1280 Main St. W, Hamilton, ON Canada.
Population Health Research Institute, Hamilton Health Sciences, Hamilton, ON Canada.
Pilot Feasibility Stud. 2017 Nov 21;3:49. doi: 10.1186/s40814-017-0189-9. eCollection 2017.
Patient decision aids (PtDA) support quality decision-making. The aim of this research was to evaluate the feasibility of conducting a randomized controlled trial delivering an implantable cardioverter defibrillator (ICD)-specific PtDA to new ICD candidates and examining preliminary estimates of differences in outcomes.
Prior to recruitment, ICD candidacy was determined. Consented patients were randomized to (1) usual care or (2) PtDA intervention. Feasibility outcomes included referral and recruitment rates, successful PtDA delivery, and completion of measures. The PtDA intervention was administered prior to specialist consultation and baseline demographics, and measures of decision quality including decisional conflict (DCS), SURE test (Sure of myself, Understand information, Risk-benefit ratio, Encouragement), patient's ICD specific values, ICD knowledge, and health-related quality of life were recorded. Post-consultation, participant's DCS was repeated and decisions to proceed, decline, or defer ICD implantation were collected. Feasibility data was determined using descriptive statistics (continuous and categorical). Preliminary estimates of differences in outcomes were assessed using mean differences. Concordance between values and decision choice was assessed using logistic regression of the intervention group.
We identified 135 eligible patients. Eighty-two consented to the trial randomizing patients to usual care ( = 41) or PtDA intervention ( = 41). Feasibility outcome results were (1) referral rate at approximately 20/month, (2) recruitment rate 61%, and (3) successful delivery of PtDA and study management. Pre-consultation, PtDA patients scored lower on the DCS scale (mean, standard deviation [SD] 27.3 (18.4) compared to usual care, 49.4 (18.6); the between-group difference in means [95% confidence interval (CI)] was - 22.1[- 30.23, - 13.97]. A difference remained post-implantation 21.2 (11.7), PtDA intervention 29.9 (13.3), and usual care - 8.7 [- 14.61, - 2.86]. SURE test results supported DCS differences. The PtDA group scored higher on the ICD-related knowledge questions, with 47.50% scoring greater than 3/5 of the knowledge questions correct, compared to 23.09% receiving usual care. The mean [SD] number of correct knowledge responses out of 5 was 3.33(1.19) in the PtDA group and 2.62 (1.16) in usual care pre-implant. Concordance between values and decision choice found a strong association between predicted and actual ICD implant status in the intervention group.
Our results suggest that a future definitive trial is feasible. The ICD-specific PtDA shows promise with respect to preliminary estimates of differences in outcomes.
NCT01876173.
患者决策辅助工具（PtDA）有助于做出高质量的决策。本研究的目的是评估对新的植入式心脏复律除颤器（ICD）候选患者开展一项随机对照试验的可行性，该试验将提供特定于ICD的PtDA，并检验结局差异的初步估计值。
在招募之前，确定ICD候选资格。同意参与的患者被随机分为：（1）常规护理组或（2）PtDA干预组。可行性结局包括转诊率和招募率、PtDA的成功交付以及测量指标的完成情况。PtDA干预在专科会诊和基线人口统计学数据收集之前进行，并记录决策质量的测量指标，包括决策冲突（DCS）、SURE测试（自信、理解信息、风险效益比、鼓励）、患者特定于ICD的价值观、ICD知识以及健康相关生活质量。会诊后，重复测量参与者的DCS，并收集继续、拒绝或推迟ICD植入的决策。可行性数据通过描述性统计（连续和分类数据）确定。结局差异的初步估计值使用均值差异进行评估。干预组使用逻辑回归评估价值观与决策选择之间的一致性。
我们确定了135名符合条件的患者。82名患者同意参与试验，将患者随机分为常规护理组（n = 41）或PtDA干预组（n = 41）。可行性结局结果为：（1）转诊率约为每月20例，（2）招募率为61%，（3）PtDA和研究管理的成功交付。会诊前，PtDA组患者在DCS量表上的得分较低（均值，标准差[SD]为27.3（18.4），而常规护理组为49.4（18.6）；两组均值之间的差异[95%置信区间（CI）]为 - 22.1[- 30.23， - 13.97]。植入后仍存在差异，PtDA干预组为21.2（11.7），常规护理组为29.9（13.3），差异为 - 8.7[- 14.61， - 2.86]。SURE测试结果支持DCS差异。PtDA组在ICD相关知识问题上得分更高，47.50%的患者在知识问题中答对超过3/5，而接受常规护理的患者为23.09%。植入前，PtDA组在5个知识问题中正确回答的平均[SD]数量为3.33（1.19），常规护理组为2.62（1.16）。干预组中价值观与决策选择之间的一致性发现预测的和实际的ICD植入状态之间存在强关联。
我们的结果表明未来进行确定性试验是可行的。特定于ICD的PtDA在结局差异的初步估计方面显示出前景。
NCT01876173。
