Clinical trial NCT05853848: Mammogram Mail- and Phone-based Interventions
Official title: Randomized Comparison of Mail- and Phone-based Interventions Promoting Mammogram Screening
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: Economics, Behavioral
Mammography
Risk Reduction Behavior
Communication
Lead sponsor: Geisinger Clinic
Sponsor class: OTHER
First posted: 2023-05-11
Enrollment: 14386
Sex: FEMALE
Minimum age (years): 51
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: SCREENING

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Mammogram completed
timeFrame: In the 180 days following the patient's intervention send date
measure: Mammogram completed
timeFrame: In the 120 days following the patient's intervention send date
Secondary outcomes:
Other outcomes:
measure: Mammogram completed
timeFrame: In the 180 days following the patient's intervention send date
measure: Breast malignancy risk detected
timeFrame: In the 210 days following the patient's intervention send date
measure: Mammogram appointment scheduled
timeFrame: In the 30 days following the patient's intervention send date
Locations:
city: Danville
country: United States
facility: Geisinger
state: Pennsylvania
Study officials:
affiliation: Geisinger Clinic
name: Amir Goren, PhD
role: PRINCIPAL_INVESTIGATOR
References: