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临床试验/NCT06812208
NCT06812208尚未招募不适用

Implementation Strategies to Decentralize Breast Ultrasound Services and Facilitate Timely Breast Cancer Diagnoses in Rwanda

Brigham and Women's Hospital1 个研究点 分布在 1 个国家目标入组 1,792 人开始时间: 2027年1月1日最近更新:
适应症
干预措施

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

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

Experimental

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

Active Comparator

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Lydia Pace, MD, MPH

Associate Professor of Medicine

Brigham and Women's Hospital

研究点 (1)

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