Implementation Strategies to Decentralize Breast Ultrasound Services and Facilitate Timely Breast Cancer Diagnoses in Rwanda
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 1,792
- 试验地点
- 1
- 主要终点
- Penetration of diagnostic breast ultrasound provision in district hospitals
研究概览
简要总结
Diagnosing breast cancer early is critical to reduce preventable breast cancer deaths in sub-Saharan Africa. This can be done in part through increasing patients' access to breast ultrasound, which is essential for evaluating breast masses. However, ultrasound is typically provided only by radiologists at urban referral hospitals. Training clinicians at rural district hospitals who are not radiologists could increase patients' access to breast ultrasound, but strategies to support and supervise these clinicians and ensure they are providing high-quality ultrasound services has not been studied.
This project will examine the effectiveness and cost of two strategies for training non-radiologist clinicians to perform breast ultrasound in Rwandan district hospitals.
详细描述
Breast cancer cases and deaths are rising rapidly in low- and middle-income countries (LMIC), including in sub-Saharan Africa, where most women with breast cancer are diagnosed with advanced-stage disease. Largely because of late-stage presentations, breast cancer survival in sub-Saharan Africa is poor. To address these global breast cancer inequities, the World Health Organization has emphasized the need for expanded access to breast cancer diagnostics in LMIC, and particularly calls for strategies that decentralize diagnostic testing to primary- and secondary-level health facilities while maintaining care quality. Diagnostic breast ultrasound (U/S) is an evidence-based intervention that is essential in evaluation of palpable breast abnormalities, including for determining which lesions require biopsy. However, diagnostic breast U/S is typically only provided by radiologists at LMIC referral facilities and is hard for low-income rural patients to access, impeding quality, equity, timeliness and efficiency of breast evaluation and contributing to diagnostic inefficiencies and delays. To address this issue, Rwanda's chief health implementation agency (Rwanda Biomedical Centre) has called for decentralized provision of breast U/S at district hospitals through task-shifting to non-radiologist clinicians. Supportive supervision is regarded as essential for successful task-shifting. However, scalable strategies for clinical supervision of non-radiologist clinicians to ensure sustained provision of high-quality decentralized breast ultrasound have not been investigated. The investigators' preliminary work training a small group of non-radiologist clinicians in Rwanda suggests that virtual support through electronically shared images and asynchronous feedback is feasible and potentially beneficial after intensive and prolonged in person training. However, supervision with real-time teleultrasound technology could be more effective in facilitating ultrasound provision and quality in a broader population of district hospital clinicians receiving shortened in-person training.
The objective of this research project is to compare 2 implementation strategies (teleultrasound supervision and asynchronous virtual feedback) to facilitate decentralized breast ultrasound at Rwandan district hospitals. The investigators will conduct a hybrid Type 2 implementation-effectiveness trial to accomplish this.
In Aim 1, the investigators will compare the strategies' impact on penetration of guideline-concordant diagnostic breast ultrasound at district hospitals (implementation effectiveness).
In Aim 2, the investigators will compare the strategies' impact on trainee-performed breast U/S image quality at district hospitals (clinical effectiveness).
In Aim 3, the investigators will estimate the implementation strategies' costs and cost-effectiveness in facilitating high-quality breast U/S, as well as examine downstream cost offsets associated with decentralized breast U/S.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
盲法说明
The research team members who are evaluating the strategies will not know which district hospitals belong to each arm.
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Enrollment in this cluster randomized clinical trial will occur at the health facility level.
- •Inclusion Criteria:
- •District hospital in Rwanda;
- •Already implementing the Women's Cancer Early Detection Program in their districts (i.e. clinicians in health centers and hospitals in the district have received the nationally-sponsored trainings in breast cancer early detection and cervical cancer screening);
- •Already using the WCEDP electronic medical record in health centers and the district hospital, or prepared to start using it.
排除标准
- •1. Already providing routine breast ultrasound in the district hospital.
研究组 & 干预措施
Teleultrasound
Arm 1 hospitals will receive teleultrasound supervision using secure Reacts software which allows clinical supervisors to view ultrasound images and provide scanning feedback in real-time.
干预措施: Teleultrasound with Philips Lumify ultrasound probes and Reacts software (Behavioral)
Asynchronous virtual feedback
Arm 2 hospitals will receive asynchronous virtual feedback in which trainees will upload static images to a shared drive and mentors will email feedback within 24 hours.
干预措施: Asynchronous virtual feedback (Behavioral)
结局指标
主要结局
Penetration of diagnostic breast ultrasound provision in district hospitals
时间窗: 12 months
Number of women receiving breast U/S / number of individuals evaluated at the district hospital with a breast mass
Trainee-provided breast ultrasound quality
时间窗: 12 months
Image quality score assessed by a blind third-party radiologist using a 15-item quality metric. Score is currently being validated and finalized.
次要结局
- Fidelity to assigned clinical support implementation strategy(12 months)
- Adoption of breast U/S by clinicians(12 months)
- Maintenance of breast U/S provision(13-24 months)
- Maintenance of breast U/S volume(13-24 months)
- Feasibility of implementation strategies(Months 3,6,12)
- Appropriateness of implementation strategies(Months 3,6,12)
- Sustainment of implementation strategies(24 months)
研究者
Lydia Pace, MD, MPH
Associate Professor of Medicine
Brigham and Women's Hospital
