[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100578508":3},{"organization":4,"outcomesModule":7,"designInfo":42,"detailedDescription":51,"studyPopulation":41,"armGroups":52,"interventions":65,"overallOfficials":74,"centralContacts":78,"locations":83,"responsibleParty":95,"collaborators":98,"id":114,"slug":115,"hasResults":116,"nctId":117,"briefTitle":118,"officialTitle":119,"acronym":41,"eligibilityCriteria":120,"healthyVolunteers":121,"sex":122,"minAge":41,"maxAge":41,"enrollmentInfo":123,"targetDuration":41,"studyType":126,"phases":127,"briefSummary":129,"conditions":130,"keywords":134,"overallStatus":140,"whyStopped":41,"lastUpdateSubmitDate":141,"lastUpdatePostDateStruct":142,"startDateStruct":145,"completionDateStruct":147,"leadSponsor":149,"locationsCount":150},{"fullName":5,"class":6},"Brigham and Women's Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":41},[9,13],{"measure":10,"description":11,"timeFrame":12},"Penetration of diagnostic breast ultrasound provision in district hospitals","Number of women receiving breast U\u002FS \u002F number of individuals evaluated at the district hospital with a breast mass","12 months",{"measure":14,"description":15,"timeFrame":12},"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.",[17,20,23,27,30,34,37],{"measure":18,"description":19,"timeFrame":12},"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)",{"measure":21,"description":22,"timeFrame":12},"Adoption of breast U\u002FS by clinicians","% of weeks in which ultrasound is provided",{"measure":24,"description":25,"timeFrame":26},"Maintenance of breast U\u002FS provision","% of weeks that U\u002FS is provided","13-24 months",{"measure":28,"description":29,"timeFrame":26},"Maintenance of breast U\u002FS volume","Number of U\u002FS scans per week",{"measure":31,"description":32,"timeFrame":33},"Feasibility of implementation strategies","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.","Months 3,6,12",{"measure":35,"description":36,"timeFrame":33},"Appropriateness of implementation strategies","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.",{"measure":38,"description":39,"timeFrame":40},"Sustainment of implementation strategies","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).","24 months",null,{"allocation":43,"interventionModel":44,"interventionModelDescription":45,"primaryPurpose":6,"observationalModel":41,"timePerspective":41,"maskingInfo":46},"RANDOMIZED","PARALLEL","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).",{"masking":47,"maskingDescription":48,"whoMasked":49},"SINGLE","The research team members who are evaluating the strategies will not know which district hospitals belong to each arm.",[50],"OUTCOMES_ASSESSOR","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\u002FS) 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\u002FS 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\u002FS 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.\n\nThe 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.\n\nIn Aim 1, the investigators will compare the strategies' impact on penetration of guideline-concordant diagnostic breast ultrasound at district hospitals (implementation effectiveness).\n\nIn Aim 2, the investigators will compare the strategies' impact on trainee-performed breast U\u002FS image quality at district hospitals (clinical effectiveness).\n\nIn Aim 3, the investigators will estimate the implementation strategies' costs and cost-effectiveness in facilitating high-quality breast U\u002FS, as well as examine downstream cost offsets associated with decentralized breast U\u002FS.\n\nThese findings will directly inform breast cancer diagnosis pathways in Rwanda, shape the workforce and credentialing processes for breast U\u002FS, 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.",[53,59],{"label":54,"type":55,"description":56,"interventionNames":57},"Teleultrasound","EXPERIMENTAL","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.",[58],"Behavioral: Teleultrasound with Philips Lumify ultrasound probes and Reacts software",{"label":60,"type":61,"description":62,"interventionNames":63},"Asynchronous virtual feedback","ACTIVE_COMPARATOR","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.",[64],"Behavioral: Asynchronous virtual feedback",[66,71],{"type":67,"name":68,"description":69,"armGroupLabels":70,"otherNames":41},"BEHAVIORAL","Teleultrasound with Philips Lumify ultrasound probes and Reacts software","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\u002FS 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\u002FS images and the trainee's probe and hand position to provide real-time feedback.",[54],{"type":67,"name":60,"description":72,"armGroupLabels":73,"otherNames":41},"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\u002F technique and management; trainees can also email questions.",[60],[75],{"name":76,"affiliation":5,"role":77},"Lydia E Pace, MD, MPH","PRINCIPAL_INVESTIGATOR",[79],{"name":76,"role":80,"phone":81,"phoneExt":41,"email":82},"CONTACT","4154657223","lpace@bwh.harvard.edu",[84],{"facility":85,"status":41,"city":86,"state":41,"zip":41,"country":87,"countryCode":88,"cosmosGeoPoint":89,"geoPoint":94,"contacts":41},"Partners in Health (Inshuti Mu Buzima)","Butaro","Rwanda","RW",{"type":90,"coordinates":91},"Point",[92,93],29.8313,-1.4079,{"lat":93,"lon":92},{"type":77,"investigatorFullName":96,"investigatorTitle":97,"investigatorAffiliation":5,"oldNameTitle":41,"oldOrganization":41},"Lydia Pace, MD, MPH","Associate Professor of Medicine",[99,101,103,105,107,109,111],{"name":100,"class":6},"Partners in Health",{"name":102,"class":6},"Memorial Sloan Kettering Cancer Center",{"name":104,"class":6},"University of Pennsylvania",{"name":106,"class":6},"Harvard Medical School (HMS and HSDM)",{"name":108,"class":6},"Obafemi Awolowo University",{"name":110,"class":6},"Kaiser Permanente",{"name":112,"class":113},"National Cancer Institute (NCI)","NIH","100578508","strategies-to-decentralize-breast-ultrasound-in-rwanda-100578508",false,"NCT06812208","Strategies to Decentralize Breast Ultrasound in Rwanda","Implementation Strategies to Decentralize Breast Ultrasound Services and Facilitate Timely Breast Cancer Diagnoses in Rwanda","Enrollment in this cluster randomized clinical trial will occur at the health facility level.\n\nInclusion Criteria:\n\n1. District hospital in Rwanda;\n2. 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);\n3. Already using the WCEDP electronic medical record in health centers and the district hospital, or prepared to start using it.\n\nExclusion Criteria:\n\n1\\. Already providing routine breast ultrasound in the district hospital.",true,"ALL",{"count":124,"type":125},1792,"ESTIMATED","INTERVENTIONAL",[128],"NA","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.\n\nThis project will examine the effectiveness and cost of two strategies for training non-radiologist clinicians to perform breast ultrasound in Rwandan district hospitals.",[131,132,133],"Breast Cancer","Early Detection of Cancer","Ultrasonography",[135,136,137,138,139,87],"breast ultrasound","implementation strategies","low and middle income countries","breast cancer early detection","teleultrasound","NOT_YET_RECRUITING","2026-06-01",{"date":143,"type":144},"2026-06-02","ACTUAL",{"date":146,"type":125},"2027-01",{"date":148,"type":125},"2029-11-30",{"name":5,"class":6},1]