Strategies to Decentralize Breast Ultrasound in Rwanda

Not Applicable

Not yet recruiting

• Conditions: Breast Cancer; Early Detection of Cancer; Ultrasonography

• Registration Number: NCT06812208
• Lead Sponsor: Brigham and Women's Hospital

Brief Summary

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.

Detailed 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.

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-25
• Study First Submitted QC: 2025-01-31
• Last Update Submitted: 2025-01-31
• Study First Posted: 2025-02-06
• Last Update Posted: 2025-02-06
• Study Start: 2026-04-01
• Primary Completion: 2028-07-01
• Study Completion: 2029-11-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1792

Inclusion Criteria

1. District hospital in Rwanda;
2. 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);
3. Already using the WCEDP electronic medical record in health centers and the district hospital, or prepared to start using it.

Exclusion Criteria

1. Already providing routine breast ultrasound in the district hospital.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Penetration of diagnostic breast ultrasound provision in district hospitals	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	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.

Secondary Outcome Measures

Name	Time	Method
Fidelity to assigned clinical support implementation strategy	12 months	Out of total number of ultrasounds performed, % performed using the assigned clinical support strategy (teleultrasound or asynchronous feedback)
Adoption of breast U/S by clinicians	12 months	% of weeks in which ultrasound is provided
Maintenance of breast U/S provision	13-24 months	% of weeks that U/S is provided
Maintenance of breast U/S volume	13-24 months	Number of U/S scans per week
Feasibility of implementation strategies	Months 3,6,12	4-item instrument measuring the feasibility of an intervention, included in clinician and site leadership surveys. Scores can range from 0-20, with higher scores indicating greater feasibility.
Appropriateness of implementation strategies	Months 3,6,12	4-item measure of appropriateness of intervention, included in clinician and site leadership surveys. Score can range from 0-20. Higher scores indicate greater appropriateness.
Sustainment of implementation strategies	24 months	3-item Provider REport of Sustainment Scale (PRESS) included in clinician and leadership surveys. Each item is scored 0 = not at all, 1 = to a slight extent, 2 = to a moderate extent, 3 = to a great extent, and 4 = to a very great extent. Minimum score=0 (not sustained); maximum score=12 (sustained to a great degree).

Trial Locations

Locations (1)

Partners in Health (Inshuti Mu Buzima); 🇷🇼 Butaro, Rwanda