Reducing Provider Workload While Preserving Patient Safety: A 2-Way Texting Intervention in Zimbabwe's Voluntary Medical Male Circumcision Program
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 780
- 试验地点
- 5
- 主要终点
- Cumulative adverse event (AE) rate (moderate or severe)
研究概览
简要总结
Voluntary medical male circumcision (VMMC) in sub-Saharan Africa is safe: the average rate of moderate and severe adverse events (AEs) at the country level is 0.8%, corresponding to 99% of men healing without incident. To reach the global target of 20 million by 2018, VMMC productivity needs to double in countries already plagued by severe healthcare worker shortages like Zimbabwe. The ZAZIC consortium partners with the Zimbabwe Ministry of Health and Child Care (MoHCC) and performed over 120,000 VMMCs. Current VMMC care in Zimbabwe requires in-person, follow-up visits at post-operative days 2,7, and 42. Over 95% adhere to multiple follow-up visits within 14 days of VMMC. ZAZIC's program has an overall AE rate of 0.4%; therefore, overstretched clinic staff conducted more than 200,000 unnecessary reviews for VMMC clients without complications. High mobile phone ownership, severe healthcare worker shortages, and rapid VMMC scale up make ZAZIC's VMMC program an ideal setting to test a mobile health (mHealth) intervention to reduce provider workload while safeguarding patient safety. Through an un-blinded, prospective, randomized, control trial (RCT) in high-volume facilities providing VMMC, ZAZIC will implement an interactive, two-way texting (2wT) intervention to identify men healing without complication, allowing them to decline routine in-person follow up visits. 2wT will simultaneously identify men with any sign of an adverse event, encouraging rapid in-person follow-up when an AE is suspected on any day, reducing unnecessary visits while maintaining quality care. We aim to 1) determine if 2wT can safely reduce VMMC follow-up visits; 2) estimate the cost savings associated with 2wT over routine VMMC follow-up; and 3) assess the acceptability and feasibility of 2wT for further scale-up. It is expected that this intervention with be as safe as routine care while providing distinct advantages in terms of efficiency, costs, and reduced healthcare worker burden. This approach is innovative as it focuses on using a low-cost mHealth intervention to reduce provider workload without deterioration in quality care. The success of this intervention could lead to adoption of this intervention at the national level, increasing efficiency of VMMC scale up and reducing burdens on providers and patients
详细描述
The investigators propose to maintain patient safety while reducing the substantial VMMC follow-up workload burden by using two-way mobile phone texts to provide in-person review only for men who indicate a desire or need for follow-up. This tailored approach to post-procedure VMMC care could reduce unnecessary visits and remove barriers for VMMC clients without deterioration of quality care. ZAZIC's diverse, expert team of researchers from the University of Washington, Seattle, USA; the University of Zimbabwe; Medic Mobile, Nairobi, Kenya; and Zimbabwean partner organizations will test this mHealth intervention. The investigators believe that bi-directional, interactive, text-based short message service (SMS) during the most critical 14 days after circumcision will help men identify and act on any sign of an adverse event, thereby seeking in-person follow-up only when an AE is suspected and reducing unnecessary visits. Reduced in-person follow-up could also free healthcare workers to perform additional VMMC surgeries. Using a prospective, randomized control trial (RCT), our intervention compares two groups of clients with cell phones: 1) standard care (control group) and 2) clients who receive and respond to a daily text with in-person follow-up only if desired or if an AE is suspected (intervention). Both arms complete a study-specific, Day 14, in-person, follow-up review for verification of self-reports (intervention) and comparison (control). Our specific aims are to:
Aim 1: Determine if 2-way texting can safely reduce VMMC follow-up visits Approach: Un-blinded, prospective, non-inferiority, RCT in high-volume facilities providing VMMC. Two-way texting (2wT) will provide interactive, text-based follow-up. 2wT men healing without complication could decline in-person follow-up; those with suspected AEs will be referred to in-person care. The investigators will compare the safety outcome of combined moderate or severe AE rate ≤ Day 14 post-VMMC and the workload outcome of average number of in-person follow-up visits between control and intervention arms.
Aim 2: Estimate the cost savings associated with 2wT over routine VMMC follow-up Approach: The investigators will determine the programmatic costs of 2wT from a systems perspective, including the technology [24], healthcare worker costs, and client perspective. The investigators will estimate the incremental intervention costs relative to standard practice to quantify gains in healthcare efficiency for scale-up and adoption.
Aim 3: Assess the acceptability and feasibility of 2wT for further scale-up Approach: Qualitative interviews with VMMC healthcare workers and brief quantitative interviews with 2wT clients inform intervention acceptance. Meetings with local researchers and collaborators will further assess feasibility, adaptation, open-source collaborative development, and system integration for replication and sustainability in Zimbabwe and the region.
APPROACH Study overview: Following usability testing with both healthcare workers and 2wT VMMC clients, The investigators will test if two-way texting (2wT) reduces unnecessary follow-up visits without compromising patient safety (Aim 1) using a randomized control trial in large, urban VMMC clinics. The investigators will assess the costs of 2wT from technology, healthcare worker, and client perspectives to determine the costs incurred by MoHCC if adopted for scale-up (Aim 2). The investigators will assess acceptability and feasibility working towards system integration and sustainability in Zimbabwe and beyond (Aim 3).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Cumulative adverse event (AE) rate (moderate or severe)
时间窗: ≤ Day 14 for each participant with analysis completed in year 1.
Incidence of AEs before Day 14 will be extracted from routine VMMC data for both 2wT and control. Incident AEs on Day 14 will be identified, classified, and graded for severity using routine MoHCC protocols \[26\] and recorded on routine VMMC AE forms. The investigators will compare cumulative rates of any moderate or severe AE ≤ Day 14 between groups using Fisher's exact test as the expected number of AEs is low. The rates will be calculated per arm as: (# moderate + severe AEs)/(total # VMMC clients who attend 2, 7 or 14 Day follow-up visit). Multivariate logistic regression models (any AE v none) will quantify the magnitude of difference, adjusting for any potential confounders.
Mean number of in-person visits
时间窗: Before 42 day visit for each participant with analysis completed in year 1.
To determine follow-up visit reduction, the investigators will compare the mean number of in-person visits for intervention and control using a t-test. A multivariate linear regression model will further quantify the effect of intervention on visit reduction, adjusting for potential confounders.
2wT costs
时间窗: The costing data collection will be completed by April 2018 at the completion of all study participant follow-up. Analysis will conclude in year 1
The investigators will calculate the relative costs and outcomes (effects) of intervention versus control, including costs for technology, healthcare worker time, and client considerations (travel, text costs, missed work). The investigators will conduct both activity-based costing from the implementation perspective and from the technology perspective to extrapolate results as costs that would be incurred by the MoHCC should they elect widespread scale up of 2wT.
2WT acceptability
时间窗: The acceptability activities will be completed by April 2018 at the completion of all study participant follow-up with analysis to commence after that point. Analysis will conclude in year 1.
2wT acceptability, using study recruitment and enrollment logs in addition to the texting database, the investigators will describe levels of acceptance, participation, refusal and drop-out. The investigators will carry out key informant interviews (KIIs) with up to 8 health care workers to gauge acceptability, satisfaction, identify facilitators and barriers to program success, and ascertain suggestions for intervention improvement. KIIs will be audio recorded and transcribed. The investigators will also implement questionnaires at the Day 14 visit with a subset of 100 2wT VMMC clients to gauge satisfaction, estimate direct and indirect costs (time away from work, transportation costs), and ascertain suggestions for intervention improvement.
2WT feasibility
时间窗: The feasibility activities be completed by April 2018 at the completion of all study participant follow-up with analysis to commence after that point. Analysis will conclude in year 1.
For feasibility, costing data will be combined with usability and acceptability information.
次要结局
- AE rates on Day 14(Day 14 data collection for each participant with analysis to be completed in year 1.)
- severity of AEs.(Day 14 data collection for each participant with analysis to be completed in year 1.)
- time between 2wT AE text reporting and follow-up(Day 14 data collection for each participant with analysis to be completed in year 1.)
研究者
Caryl Feldacker
Clinical Assistant Professor
University of Washington