Status
Conditions
Treatments
About
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.
Full description
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.
These findings will directly inform breast cancer diagnosis pathways in Rwanda, shape the workforce and credentialing processes for breast U/S, and expand patients' access to this service. In addition, this project will contribute to global understanding of feasible, contextually appropriate and effective strategies to increase access to breast cancer diagnostic services (particularly imaging) in LMIC- a topic of major global interest in light of rapidly rising breast cancer incidence and mortality in LMIC.
Enrollment
Sex
Volunteers
Inclusion and exclusion criteria
Enrollment in this cluster randomized clinical trial will occur at the health facility level.
Inclusion Criteria:
Exclusion Criteria:
Primary purpose
Allocation
Interventional model
Masking
1,792 participants in 2 patient groups
Loading...
Central trial contact
Lydia E Pace, MD, MPH
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal