Predicting nursing home adherence to a clinical trial intervention: lessons for the conduct of cluster randomized trials.
Predicting nursing home adherence to a clinical trial intervention: lessons for the conduct of cluster randomized trials.
复制标题
预测疗养院对临床试验干预的依从性：进行整群随机试验的经验教训。
DOI：
10.1111/j.1532-5415.2011.03697.x
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发表时间：
2011
影响因子：
6.3
通讯作者：
Gurwitz,JerryH
中科院分区：
文献类型：
--
作者：
Tjia,Jennifer;Mazor,KathleenM;Field,Terry;Doherty,Peter;Spenard,Ann;Gurwitz,JerryH
目的探讨预测疗养院（NH）临床试验干预依从性的因素。设计：一项聚类随机试验（CRT）的事后分析，该试验评估了一种结构化的沟通干预措施，以改善NHs中护士-医生的电话沟通。依从性定义为在12个月的试验中积极参与至少3个月。假设影响试验结果的NH特征（利润状况、床位大小、护理人员时间、NH质量和领导层更替）是先验测量的。研究干预依从性、NH特征与干预前问卷应答率的关系。结果13个干预的NHs中，7个坚持干预。三个因素区分了依从性NHs和非依从性NHs：护理人员流失率（非依从性NHs 50% vs依从性NHs 0%，P= 0.03）；医疗保险和医疗补助服务中心（CMS）护士人员编制评级（范围：1-5）（非依从性NHs平均3.7±0.5 vs依从性NHs平均4.3±0.5），P= 0.048)；问卷应答率（非依从性NHs 15.6±10.0% vs依从性NHs 34.2±12.1%，P= 0.02）。在州调查中，利润状况、床位大小和NH不足的数量与干预依从性没有显著相关。结论cms护士编制评分、领导人员流动率和问卷回复率与CRT干预依从性相关。CMS对NHs人员评级的审前评估和对问卷的回应可以帮助研究者通过筛选可能坚持CRT干预的NHs来提高试验效率。
ObjectivesTo describe factors predictive of nursing home (NH) adherence to a clinical trial intervention.DesignPost hoc analysis of a cluster randomized trial (CRT) evaluating a structured communication intervention to improve nurse–physician telephone communication in NHs.SettingNH.ParticipantsAll eligible licensed nursing staff in all participating NHs.MeasurementsAdherence was defined as active participation for at least 3 months of the 12‐month trial. NH characteristics hypothesized to affect trial outcomes (profit status, bed size, nursing staff time, NH quality, and leadership turnover) were measured a priori. The association between intervention adherence, NH characteristics and preintervention questionnaire response rate was examined.ResultsOf 13 intervention NHs, seven adhered to the intervention. Three factors differentiated adherent from nonadherent NHs: director of nursing turnover (nonadherent NHs 50% vs adherent NHs 0%,P= .03); Centers for Medicare and Medicaid Services (CMS) nurse staffing rating (range: 1–5) (nonadherent NHs mean 3.7 ± 0.5 vs adherent NHs mean 4.3 ± 0.5),P= .048); and questionnaire response rate (nonadherent NHs 15.6 ± 10.0% vs adherent NHs 34.2 ± 12.1%,P= .02). Profit status, bed size, and number of NH deficiencies on state surveys were not significantly associated with intervention adherence.ConclusionCMS nurse staffing rating, leadership turnover, and questionnaire response rate are associated with adherence to a CRT intervention. Pretrial evaluation of NH staffing rating by CMS and of response to a questionnaire can help investigators improve trial efficiency by screening for NHs likely to adhere to a CRT intervention.