Clinical trial NCT06812208: Strategies to Decentralize Breast Ultrasound in Rwanda
Official title: Implementation Strategies to Decentralize Breast Ultrasound Services and Facilitate Timely Breast Cancer Diagnoses in Rwanda
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Breast Cancer
Early Detection of Cancer
Ultrasonography
Keywords: breast ultrasound
implementation strategies
low and middle income countries
breast cancer early detection
teleultrasound
Rwanda
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: Partners in Health
name: Memorial Sloan Kettering Cancer Center
name: University of Pennsylvania
name: Harvard Medical School (HMS and HSDM)
name: Obafemi Awolowo University
name: Kaiser Permanente
name: National Cancer Institute (NCI)
First posted: 2025-02-06
Enrollment: 1792
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a Type 2 hybrid implementation-effectiveness study designed to compare the effect of synchronous teleultrasound mentorship versus asynchronous virtual feedback (implementation strategies) on penetration of breast ultrasound into district hospital practice (implementation outcome) and ultrasound quality (clinical outcome).
Primary purpose: OTHER

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.

Eligibility criteria: Enrollment in this cluster randomized clinical trial will occur at the health facility level.

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.

Primary outcomes:
measure: Penetration of diagnostic breast ultrasound provision in district hospitals
timeFrame: 12 months
measure: Trainee-provided breast ultrasound quality
timeFrame: 12 months
Secondary outcomes:
measure: Fidelity to assigned clinical support implementation strategy
timeFrame: 12 months
measure: Adoption of breast U/S by clinicians
timeFrame: 12 months
measure: Maintenance of breast U/S provision
timeFrame: 13-24 months
measure: Maintenance of breast U/S volume
timeFrame: 13-24 months
measure: Feasibility of implementation strategies
timeFrame: Months 3,6,12
measure: Appropriateness of implementation strategies
timeFrame: Months 3,6,12
measure: Sustainment of implementation strategies
timeFrame: 24 months
Other outcomes:
Locations:
city: Butaro
country: Rwanda
facility: Partners in Health (Inshuti Mu Buzima)
Study officials:
affiliation: Brigham and Women's Hospital
name: Lydia E Pace, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: