Strategies to Decentralize Breast Ultrasound in Rwanda

Conditions

• Breast Cancer
• Early Detection of Cancer
• Ultrasonography

Eligibility Criteria

Sex

ALL

Age

N/A - N/A

Healthy Volunteers

Accepted

Interventions

• Teleultrasound with Philips Lumify ultrasound probes and Reacts software — BEHAVIORAL
  Clinicians at hospitals randomized to Arm 1 will be provided with Reacts licenses and trained to use Reacts with Philips Lumify devices immediately following the baseline training. Each hospital will be assigned to 2-3 radiologist supervisors (typically 1 Rwandan, 1 U.S.-based), with at least one available on each designated U/S clinic day to provide real-time teleultrasound mentorship. Clinician trainees scan the breast, document their independent findings and management plan in the study REDCap database, and then "call" the supervisor using Reacts. Reacts permits supervisor and trainee to see each other virtually; the supervisor can also view live U/S images and the trainee's probe and hand position to provide real-time feedback.
• Asynchronous virtual feedback — BEHAVIORAL
  Clinicians at Arm 2 hospitals will save static images, with or without video at clinicians' discretion, onto the Philips Lumify tablets. These will be uploaded to a secure internet-based folder with case descriptions, and assigned U.S.- and Rwanda-based experts will be notified that images are available. Experts will review images within 24 hours and email feedback to trainees on imaging quality/ technique and management; trainees can also email questions.

Study Details

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.

Key Dates

First listed

Feb 6, 2025

Start date

Jan 31, 2027

Status verified

Jun 2026

Primary completion

Jul 1, 2028

Completion

Nov 30, 2029

Study Design

Enrollment

1,792 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Arms

• Experimental: 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.
• Active Comparator: 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.

Primary Outcome Measure

Penetration of diagnostic breast ultrasound provision in district hospitals [ Time Frame: 12 months ]

Central Contacts

• Lydia E Pace, MD, MPH
  4154657223
  [email protected]

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