Clinician Nudge to Referral of Adnexal Masses to Gynecologic Oncology

NCT07078409 | Enrolling By Invitation

• 2 other identifiers: 858390HT9425-25-1-0243
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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

Keywords

nudge

Outcome Measures

Primary Outcomes (1)

• Referral Rate

  Binary indicator of whether the patient was referred to gynecologic oncology within 14 days of abnormal imaging results.

  Up to one year

Secondary Outcomes (2)

• Gynecologic Oncology Visit

  Up to one year

• Time from imaging to visit

  Up to one year

Study Arms (2)

Nudge

EXPERIMENTAL

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.

Behavioral: Nudge

Control

NO INTERVENTION

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.

Interventions

Nudge 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.

Nudge

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19140, United States

Location

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Gynecologic Oncology, Perelman School of Medicine

Study Record Dates

• First Submitted: June 25, 2025
• First Posted: July 22, 2025
• Study Start: July 14, 2025
• Primary Completion (Estimated): July 7, 2026
• Study Completion (Estimated): July 7, 2027
• Last Updated: July 22, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Access Criteria: Beginning 1 year after publication with no end date.

Locations

US (1)