The RE-AIM framework with objectives.

IntroductionLow-resourced settings often lack personnel and infrastructure for alcohol use disorder treatment. We culturally adapted a Brief Negotiational Interview (BNI) for Emergency Department injury patients, the “Punguza Pombe Kwa Afya Yako (PPKAY)” (“Reduce Alcohol For Your Health”) in Tanzania. This study aimed to evaluate the feasibility of a pragmatic randomized adaptive controlled trial of the PPKAY intervention.Materials and methodsThis feasibility trial piloted a single-blind, parallel, adaptive, and multi-stage, block-randomized controlled trial, which will subsequently be used to determine the most effective intervention, with or without text message booster, to reduce alcohol use among injury patients. We reported our feasibility pilot study using the Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) framework, with recruitment and retention rates being our primary and secondary outcomes. We enrolled adult patients seeking care for an acute injury at the Kilimanjaro Christian Medical Center in Tanzania if they (1) exhibited an Alcohol Use Disorder Identification Test (AUDIT) ≥8, (2) disclosed alcohol use prior to injury, or (3) had a breathalyzer ≥0.0 on arrival. Intervention arms were usual care (UC), PPKAY, PPKAY with standard text booster, or a PPKAY with a personalized text booster.ResultsOverall, 181 patients were screened and 75 enrolled with 80% 6-week, 82.7% 3-month and 84% 6-month follow-up rates showing appropriate Reach and retention. Adoption measures showed an overwhelmingly positive patient acceptance with 100% of patients perceiving a positive impact on their behavior. The Implementation and trial processes were performed with high rates of PPKAY fidelity (76%) and SMS delivery (74%). Intervention nurses believed Maintenance and sustainability of this 30-minute, low-cost intervention and adaptive clinical trial were feasible.ConclusionsOur intervention and trial design are feasible and acceptable, have evidence of good fidelity, and did not show problematic deviations in protocol. Results suggest support for undertaking a full trial to evaluate the effectiveness of the PPKAY, a nurse-driven BNI in a low-income country.Trial registrationTrial registration numberNCT02828267. https://classic.clinicaltrials.gov/ct2/show/NCT02828267.

引言
资源匮乏地区往往缺乏酒精使用障碍治疗所需的人员与基础设施。本研究针对坦桑尼亚急诊科创伤患者，对简短协商访谈（Brief Negotiational Interview, BNI）进行文化适配，开发出“Punguza Pombe Kwa Afya Yako（缩写PPKAY，意为“减少饮酒以守护健康”）”干预方案。本研究旨在评估针对该PPKAY干预方案开展务实性随机自适应对照试验的可行性。

材料与方法
本可行性预试验对一项单盲、平行、自适应多阶段区组随机对照试验进行试点，后续将基于该试验明确是否添加短信助推干预可最有效地降低创伤患者的饮酒量。本可行性预试验采用达及性、有效性、采纳性、实施性、维持性（Reach, Effectiveness, Adoption, Implementation, Maintenance, RE-AIM）框架进行报告，以招募率和保留率作为主要与次要结局指标。本研究纳入坦桑尼亚乞力马扎罗基督教医疗中心因急性创伤就诊的成年患者，纳入标准为：(1) 酒精使用障碍识别测试（Alcohol Use Disorder Identification Test, AUDIT）得分≥8；(2) 受伤前有饮酒史；(3) 入院时呼气酒精检测仪检测值≥0.0。本研究设置4组干预方案：常规护理（常规治疗，UC）、PPKAY干预、PPKAY联合标准短信助推干预、PPKAY联合个性化短信助推干预。

结果
本研究共筛查181例患者，最终入组75例；6周、3个月及6个月随访率分别为80%、82.7%及84%，提示达及性与保留性均符合要求。采纳性评估结果显示患者接受度极高，100%的患者认为该干预对自身行为产生了积极影响。试验实施与流程层面的PPKAY干预保真度达76%，短信（Short Message Service, SMS）发送率为74%。参与干预的护士认为，这项时长30分钟、低成本的干预方案及自适应临床试验的维持性与可持续性均具备可行性。

结论
本研究的干预方案与试验设计具备可行性与可接受性，干预保真度良好，未出现违反试验方案的严重偏差。研究结果支持开展大规模完整试验，以评估PPKAY这一护士主导的BNI干预方案在低收入国家的应用效果。

试验注册
试验注册号：NCT02828267。访问链接：https://classic.clinicaltrials.gov/ct2/show/NCT02828267。