Clinical trial · Interventional
Opt-in vs. Opt-out for Breast Cancer Screening
Opt-in vs. Opt-out Mammography Screening Outreach: a Randomized Controlled Trial
NCT05313737CI-TRIAL-00057618unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a randomized controlled trial that will evaluate the effectiveness two different outreach strategies for a population-based breast cancer screening program at the VA Puget Sound among average risk female Veterans who are due for breast cancer screening.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Automated message | Other | — | UNRESOLVED |
| Opt-out scheduling | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Automated phone opt-in message
- description
- Audiocare message requiring Veteran to confirm that they would like to participate in screening and have consult sent
- interventionNames
- Other: Automated message
- type
- EXPERIMENTAL
- label
- Opt-out scheduling
- description
- Consult automatically sent and Veteran called to schedule screening
- interventionNames
- Other: Opt-out scheduling
Primary outcomes (1)
- measure
- Percentage of mammograms completed at 100 days post randomization
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 45 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * female Veterans aged 45-75 * assigned to a primary care provider at the VA Puget Sound as of January 1, 2022 with at least 1 year of prior data available * due for breast cancer screening (have not had a mammogram in the last 12 months) Exclusion Criteria: * must not be any indication of current receipt of hospice care * no record of recent death in the administrative data * not scheduled for either a screening or diagnostic mammogram within the following 12 weeks from assessment. * not have a personal history of bilateral mastectomy.
References
Publications (1)
- DERIVEDMarcotte LM, Deeds S, Wheat C, Gunnink E, Gray K, Rojas J, Finch C, Nelson K, Reddy A. Automated Opt-Out vs Opt-In Patient Outreach Strategies for Breast Cancer Screening: A Randomized Clinical Trial. JAMA Intern Med. 2023 Nov 1;183(11):1187-1194. doi: 10.1001/jamainternmed.2023.4321. PMID 37695621