NCT05853848

Brief Summary

The project aims to evaluate four different versions and modalities of interventions encouraging mammogram screening among all eligible women due or overdue for screening. The evaluation will compare among the following forms of outreach to help determine whether (a) live calls are more effective at increasing mammogram screening than other forms of outreach and (b) each form of outreach is more effective than no outreach: (1) a postcard, (2) a letter, (3) an auto-dialer phone message, and (4) a live call from a care gaps team. The interventions will be rolled out over many months, allowing for comparisons of effectiveness against those who have not yet been contacted.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14,386

participants targeted

Target at P75+ for not_applicable breast-cancer

Timeline
Completed

Started May 2023

Shorter than P25 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 28, 2023

Completed
12 days until next milestone

Study Start

First participant enrolled

May 10, 2023

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 11, 2023

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2024

Completed
Last Updated

October 10, 2024

Status Verified

October 1, 2024

Enrollment Period

1.2 years

First QC Date

April 28, 2023

Last Update Submit

October 9, 2024

Conditions

Keywords

Economics, BehavioralMammographyRisk Reduction BehaviorCommunication

Outcome Measures

Primary Outcomes (2)

  • Mammogram completed

    Record of completed mammogram (yes/no), for comparing postcards, letters, and auto-dialer messages with live calls

    In the 180 days following the patient's intervention send date

  • Mammogram completed

    Record of completed mammogram (yes/no), for comparing postcards, letters, auto-dialer messages, and live calls with controls

    In the 120 days following the patient's intervention send date

Other Outcomes (3)

  • Mammogram completed

    In the 180 days following the patient's intervention send date

  • Breast malignancy risk detected

    In the 210 days following the patient's intervention send date

  • Mammogram appointment scheduled

    In the 30 days following the patient's intervention send date

Study Arms (4)

Standard postcard

ACTIVE COMPARATOR

Patients in this arm will receive a postcard with words and an image, typical of outreach in prior years, encouraging them to schedule their annual mammograms.

Behavioral: Postcard

Formal letter

EXPERIMENTAL

Patients in this arm will receive a letter from the Geisinger Health Plan (on Geisinger letterhead) noting that they're overdue for a mammogram and encouraging them to schedule.

Behavioral: Letter

Auto-dialer

EXPERIMENTAL

Patients in this arm will receive a call from an auto-dialer with a message noting that they're overdue for a mammogram and encouraging them to schedule.

Behavioral: Auto-dialer

Live call

EXPERIMENTAL

Patients in this arm will receive a call from a Geisinger Health Plan representative noting that they're overdue for a mammogram and encouraging them to schedule (and helping them schedule if they are interested).

Behavioral: Live call

Interventions

PostcardBEHAVIORAL

Postcard with phone number to call for help scheduling a mammogram.

Standard postcard
LetterBEHAVIORAL

Letter with phone number to call for help scheduling a mammogram.

Formal letter
Auto-dialerBEHAVIORAL

Auto-dialer with option to press button for help scheduling a mammogram.

Auto-dialer
Live callBEHAVIORAL

Live call offering help scheduling a mammogram.

Live call

Eligibility Criteria

Age51 Years - 74 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female Geisinger Health Plan members between ages 52 and 74 as of December 31, 2023
  • Overdue for annual mammogram
  • Continuously enrolled with the Geisinger Health Plan as of October 1, 2021
  • Can be contacted via both phone and mail

You may not qualify if:

  • Geisinger Health Plan members on a do-not-contact list
  • Had a mammogram as of October 1, 2021
  • In hospice, using hospice services, or receiving palliative care as of January 1, 2023
  • Medicare members 66 years of age or above at time of outreach, who are institutionalized or have both frailty and advanced illness
  • Had a bilateral mastectomy at any time

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Geisinger

Danville, Pennsylvania, 17822, United States

Location

MeSH Terms

Conditions

Breast NeoplasmsBehaviorRisk Reduction BehaviorCommunication

Interventions

College Fraternities and Sororities

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

OrganizationsHealth Care Economics and Organizations

Study Officials

  • Amir Goren, PhD

    Geisinger Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Model Details: Each intervention will be rolled out to only a subset of the total population each month, such that all patients will receive one of the interventions over the course of 7 months. Active arms will be compared contemporaneously against a passive control group consisting of active arm participants for whom the intervention has not yet begun, as well as a random subset of participants who are excluded before the future intervention begins.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Program Director, Behavioral Insights Team

Study Record Dates

First Submitted

April 28, 2023

First Posted

May 11, 2023

Study Start

May 10, 2023

Primary Completion

July 31, 2024

Study Completion

July 31, 2024

Last Updated

October 10, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will share

Data with no personally identifiable information will be made available to other researchers on the Open Science Framework for transparency. This will include the essential data and code needed to replicate the analysis that yielded reported findings.

Shared Documents
STUDY PROTOCOL, SAP, ANALYTIC CODE
Time Frame
By the paper's online publication date. Data will remain available for as long as the Open Science Framework hosts it.
Access Criteria
The data on the Open Science Framework will be open to anyone requesting that information.
More information

Locations