Health Trials

Strategies to Decentralize Breast Ultrasound in Rwanda

ConditionsBreast CancerEarly Detection of CancerUltrasonography
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorBrigham and Women's Hospital

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

1,792 Participants
are divided into 2 treatment groups
Group A: TeleultrasoundExperimental treatment 1 intervention
Group B: Asynchronous virtual feedbackActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Penetration of diagnostic breast ultrasound provision in district hospitals

Number of women receiving breast U/S / number of individuals evaluated at the district hospital with a breast mass

Time frame
12 months
2

Trainee-provided breast ultrasound quality

Image quality score assessed by a blind third-party radiologist using a 15-item quality metric. Score is currently being validated and finalized.

Time frame
12 months

Secondary outcomes

1

Fidelity to assigned clinical support implementation strategy

Out of total number of ultrasounds performed, % performed using the assigned clinical support strategy (teleultrasound or asynchronous feedback)

Time frame
12 months
2

Adoption of breast U/S by clinicians

% of weeks in which ultrasound is provided

Time frame
12 months
3

Maintenance of breast U/S provision

% of weeks that U/S is provided

Time frame
13-24 months
4

Maintenance of breast U/S volume

Number of U/S scans per week

Time frame
13-24 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Brigham and Women's Hospital

Lead sponsor

Partners in Health

Collaborator

Memorial Sloan Kettering Cancer Center

Collaborator

University of Pennsylvania

Collaborator

Harvard Medical School (HMS and HSDM)

Collaborator

Obafemi Awolowo University

Collaborator

Kaiser Permanente

Collaborator

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: