Clinician Nudge to Referral of Adnexal Masses to Gynecologic Oncology

NCT ID: NCT07078409

Last Updated: 2025-07-22

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-14
• Study Completion Date: 2027-07-07

Brief Summary

The goal of this study is to test the effectiveness of clinician nudges on referrals to gynecologic oncology in patients with suspected ovarian cancer.

The primary outcome will be whether or not patients were referred to gynecologic oncology within 14 days of their abnormal imaging results. Secondary and exploratory outcomes are whether the gynecologic visit occurred within 60 days of abnormal imaging and the time from abnormal imaging results to gynecologic oncology visit.

Conditions

Ovarian Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

Nudge

When the clinician who ordered the imaging that led to randomization receives the test results, a pre-checked referral order to gynecologic oncology for surgical evaluation will appear in the EHR alongside a brief educational explanation. This will constitute the opt-out default referral order (Figure 3). Clinicians will have the option to unclick the referral to opt out and will be asked to indicate the reason from a pre-populated list of choices; if they do not opt out, the referral to gynecologic oncology will proceed. Imaging findings and referral will be communicated to the patient in keeping with the clinician's usual practice. In keeping with routine practice, referred patients will be contacted by gynecologic oncology's new patient coordinators within 72 hours and offered an appointment within 2 weeks at their preferred location.

Group Type: EXPERIMENTAL

Nudge

Intervention Type: BEHAVIORAL

When the clinician who ordered the imaging that led to randomization receives the test results, a pre-checked referral order to gynecologic oncology for surgical evaluation will appear in the EHR alongside a brief educational explanation. This will constitute the opt-out default referral order (Figure 3). Clinicians will have the option to unclick the referral to opt out and will be asked to indicate the reason from a pre-populated list of choices; if they do not opt out, the referral to gynecologic oncology will proceed. Imaging findings and referral will be communicated to the patient in keeping with the clinician's usual practice. In keeping with routine practice, referred patients will be contacted by gynecologic oncology's new patient coordinators within 72 hours and offered an appointment within 2 weeks at their preferred location.

Control

Clinicians will receive imaging reports per usual practice (i.e., imaging reports that include O-RADS score with recommendation for gynecologic oncology referral in the report) and can place referral through the usual EHR-based ordering system. If referred, patients will be contacted and scheduled as described above.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Nudge

When the clinician who ordered the imaging that led to randomization receives the test results, a pre-checked referral order to gynecologic oncology for surgical evaluation will appear in the EHR alongside a brief educational explanation. This will constitute the opt-out default referral order (Figure 3). Clinicians will have the option to unclick the referral to opt out and will be asked to indicate the reason from a pre-populated list of choices; if they do not opt out, the referral to gynecologic oncology will proceed. Imaging findings and referral will be communicated to the patient in keeping with the clinician's usual practice. In keeping with routine practice, referred patients will be contacted by gynecologic oncology's new patient coordinators within 72 hours and offered an appointment within 2 weeks at their preferred location.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Eligible clinicians include physicians, physician assistants, and nurse practitioners with eligible patient encounters at sites included in the trial during the study.
• Eligible patient encounters are defined as an emergency room visit, inpatient hospitalization, or outpatient visit during the study period where the patient had associated imaging with suspected ovarian cancer (O-RADS 4 or 5 lesion), identified with the EHR-based tool described above.

Exclusion Criteria

• Known diagnosis of ovarian cancer.
• Imaging ordered by gynecologic oncologist.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Abramson Cancer Center at Penn Medicine

OTHER

Sponsor Role: lead

Responsible Party

Anna Jo Bodurtha Smith, MD, MPH, MSc

Assistant Professor, Gynecologic Oncology, Perelman School of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

HT9425-25-1-0243

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

858390

Identifier Type: -

Identifier Source: org_study_id