Fradgley Elizabeth A, Boltong Anna, O'Brien Lorna, Boyes Allison W, Lane Katherine, Beattie Annette, Clinton-McHarg Tara, Jacobsen Paul B, Doran Christopher, Barker Daniel, Roach Della, Taylor Jo, Paul Christine L
Priority Research Centre for Cancer Research Innovation and Translation, University of Newcastle, Callaghan, Australia.
Priority Research Centre for Health Behaviour, University of Newcastle, Callaghan, Australia.
JMIR Res Protoc. 2019 May 16;8(5):e12473. doi: 10.2196/12473.
Structured distress management, comprised a 2-stage screening and referral model, can direct supportive care resources toward individuals who are most likely to benefit. This structured approach has yet to be trialed in Australian community-based services such as Cancer Council New South Wales (NSW) and Victoria Cancer Information and Support (CIS) 13 11 20 lines who care for a large community of cancer patients and caregivers.
The aim of this study was to evaluate the effectiveness of structured screening and referral in (1) increasing the proportion of distressed CIS callers who accept supportive care referrals and (2) reducing distress levels at 6-month follow-up.
In this stepped-wedge trial, Cancer Council NSW and Victoria CIS consultants are randomized to deliver structured care during inbound 13 11 20 calls in accordance with 3 intervention periods. Eligible callers are patients or caregivers who score 4 or more on the Distress Thermometer; NSW or Victorian residents; aged 18 years or older; and English proficient. Study data are collected via computer-assisted telephone interviews (CATIs) at 3- and 6-month follow-up and CIS record audit. CATIs include demographic and service use items and the General Health Questionnaire (GHQ-28) to assess distress. An economic analysis of the structured care model will be completed.
The structured care model was developed by guideline review and identification of service characteristics to guide mapping decisions; place-card methodology; and clinical vignettes with think-aloud methodology to confirm referral appropriateness. The model includes an additional screening tool (Patient Health Questionnaire-4) and a referral model with 16-20 CIS services. Descriptive statistics will be used to assess referral uptake rates. Differences between GHQ-28 scores for structured and usual care callers will be tested using a generalized linear mixed model with fixed effects for intervention and each time period. The trial will recruit 1512 callers. The sample size will provide the study with approximately 80% power to detect a difference of 0.3 SD in the mean score of the GHQ-28 at an alpha level of .05 and assuming an intra-cluster correlation of .04. A random sample of recorded calls will be reviewed to assess intervention fidelity and contamination. To date, 1835 distressed callers have been invited to participate with 60.71% (1114/1835) enrolled in the study. A total of 692 participants have completed 6-month CATIs. Recruitment is anticipated to end in late 2019.
This trial is among the first to rigorously test the outcomes of a community-based structured approach to distress management. The model is evidence-informed, practice-ready, and trialed in a real-world setting. The study outcomes will advance the understanding of distress management internationally for both patients and caregivers.
Australian New Zealand Clinical Trial Registry ACTRN12617000352303; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=372105&isReview=true (Archived by WebCite on http://www.webcitation.org/78AW0Ba09).
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/12473.
结构化的痛苦管理，包括一个两阶段的筛查和转诊模式，可以将支持性护理资源导向最有可能受益的个体。这种结构化方法尚未在澳大利亚的社区服务中进行试验，如新南威尔士州癌症理事会（NSW）和维多利亚癌症信息与支持组织（CIS）13 11 20热线，它们为大量癌症患者和护理人员群体提供服务。
本研究的目的是评估结构化筛查和转诊在（1）提高接受支持性护理转诊的痛苦的CIS来电者比例以及（2）在6个月随访时降低痛苦水平方面的有效性。
在这项阶梯楔形试验中，新南威尔士州癌症理事会和维多利亚CIS的顾问被随机分配，在13 11 20个进线电话中按照3个干预期提供结构化护理。符合条件的来电者是在痛苦温度计上得分4分或更高的患者或护理人员；新南威尔士州或维多利亚州居民；年龄在18岁及以上；且精通英语。研究数据通过在3个月和6个月随访时的计算机辅助电话访谈（CATIs）以及CIS记录审核来收集。CATIs包括人口统计学和服务使用项目以及用于评估痛苦的一般健康问卷（GHQ - 28）。将完成对结构化护理模式的经济分析。
结构化护理模式是通过指南审查和服务特征识别来指导映射决策而开发的；使用名片方法；以及采用出声思考方法的临床案例来确认转诊的适宜性。该模式包括一个额外的筛查工具（患者健康问卷 - 4）和一个具有16 - 20项CIS服务的转诊模式。将使用描述性统计来评估转诊接受率。将使用具有干预和每个时间段固定效应的广义线性混合模型来检验结构化护理和常规护理来电者的GHQ - 28得分之间的差异。该试验将招募1512名来电者。样本量将为该研究提供约80%的检验效能，以在α水平为0.05且假设组内相关系数为0.04的情况下检测GHQ - 28平均得分中0.3标准差的差异。将对记录的电话进行随机抽样审查，以评估干预的保真度和污染情况。迄今为止，已邀请1835名痛苦的来电者参与，其中60.71%（1114/1835）已登记参加研究。共有692名参与者完成了6个月的CATIs。预计招募工作将于2019年底结束。
该试验是首批严格测试基于社区的结构化痛苦管理方法结果的试验之一。该模式以证据为依据，可直接应用于实践，并在实际环境中进行了试验。研究结果将推动国际上对患者和护理人员痛苦管理的理解。
澳大利亚新西兰临床试验注册中心ACTRN12617000352303；https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=372105&isReview=true（由WebCite存档于http://www.webcitation.org/78AW0Ba09）。
国际注册报告识别号（IRRID）：DERR1 - 10.2196/12473。
