Promoting Cancer Screening Among Medicaid Recipients in Minnesota

A Population-based Randomized Trial to Promote Cancer Screening Among Unscreened Medicaid Recipients in Minnesota

This study evaluates the effectiveness of persuasive direct mail materials coupled with an incentive for increasing breast and colorectal cancer screening among people enrolled in Medicaid. Half of age- and gender-appropriate enrollees received this intervention; the other half received the same intervention 15 months later

Study Overview

• Status: Completed
• Conditions: Breast Cancer; Colorectal Cancer
• Intervention / Treatment: Behavioral: Mammography direct mail coupled with a financial incentive; Behavioral: Usual care; Behavioral: Colonoscopy direct mail coupled with a financial incentive

Detailed Description

This trial was conducted between April 2014 and July 2015 and implemented through Sage, the National Breast and Cervical Cancer Early Detection Program (NBCCEDP) in Minnesota and housed within the Minnesota Department of Health (MDH). The target population was all Minnesota Medicaid recipients ages 50-74 overdue for breast cancer and colorectal cancer screening. Claims data, obtained from MDHS, were used to determine patient characteristics and outcomes. Individuals who were not enrolled in Medicaid, who were not overdue for BC or CRC screening, or who were not in the 50-74 age range were excluded prior to analysis.

To determine the efficacy of the interventions we used a two group posttest-only randomized design with all eligible MA beneficiaries randomly assigned to one of two groups: Direct Mail plus Incentive (with patient navigation) versus usual care.

The primary outcomes were completion of mammography or colonoscopy within 12 weeks after implementation of the intervention. Current Procedural Technology (CPT) codes from Medicaid claims data were used to determine if an individual had received either mammography or colonoscopy. Specific CPT codes used for mammography were conventional mammography (77055-77057), digital mammography (G0202, G0204, G0206), and computer-aided detection mammography (77051, 77052). CPT codes used for colonoscopy were G0105, G0121, 45378, and 45380-45385. Mammography and colonoscopy outcomes were measured dichotomously. Outcomes were based on the presence of screening mammography and colonoscopy claims occurring for 10 weeks after the first mailings.

The mammography and colonoscopy interventions were examined separately. Across treatment and control, study sample characteristics were compared and absolute differences were assessed using t-test and χ2 statistics. Main outcome analyses consisted of logistic regression to compute odds ratios for receiving mammography or colonoscopy and for covariate adjustment. Two separate logistic regression models were examined for both mammography and colonoscopy interventions: (1) a bivariate model that examined treatment versus control, and 2) a multivariate model that adjusted for covariates. All analyses were conducted using Stata, version 13.

Some individuals lost Medicaid coverage on a monthly basis during the study period, and others had inaccurate mailing addresses (< 2% of each study sample). Therefore not everyone received the treatment as intended, and individuals that received the intervention may not have had Medicaid claims available post-intervention. Our outcome analyses were intent-to-treat analyses that included all individuals randomized to treatment or control groups at initiation of intervention regardless of whether they lost coverage post-randomization or if they had an inaccurate mailing address.

• Study Type: Interventional
• Enrollment (Actual): 138554
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Saint Paul, Minnesota, United States, 55164
      • Minnesota Department of Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 46 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Enrolled in Minnesota Medicaid for at least the prior year

Exclusion Criteria:

• Younger than 50 or older than 74
• Women having mammogram in 15 months before trial (mammography intervention)
• Evidence of a colonoscopy in the past 10 years, flexible sigmoidoscopy in the past five years, or fecal immunochemical or fecal occult blood test in the past year (colonoscopy intervention)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mammography treatment; Mammography direct mail coupled with a financial incentive	Behavioral: Mammography direct mail coupled with a financial incentive; The intervention groups received innovative and persuasive direct mail materials coupled with an incentive for using their Medicaid benefit to get screened.
Active Comparator: Mammography control/delayed intervention; Usual care (for 15 months); Mammography direct mail coupled with financial incentive (after 15 months)	Behavioral: Mammography direct mail coupled with a financial incentive; The intervention groups received innovative and persuasive direct mail materials coupled with an incentive for using their Medicaid benefit to get screened.; Behavioral: Usual care; Group received usual care, and direct mail 15 months after treatment group received intervention.
Experimental: Colonoscopy treatment; Colonoscopy direct mail coupled with a financial incentive	Behavioral: Colonoscopy direct mail coupled with a financial incentive; The intervention groups received innovative and persuasive direct mail materials coupled with an incentive for using their Medicaid benefit to get screened.
Active Comparator: Colonoscopy control/delayed intervention; Usual care (for 15 months); Colonoscopy direct mail coupled with financial incentive (after 15 months)	Behavioral: Usual care; Group received usual care, and direct mail 15 months after treatment group received intervention.; Behavioral: Colonoscopy direct mail coupled with a financial incentive; The intervention groups received innovative and persuasive direct mail materials coupled with an incentive for using their Medicaid benefit to get screened.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
screening mammography or colonoscopy	Evidence of a mammogram received after implementation of the intervention, based on presence of CPT codes in Medicaid claims data set.	Within 12 weeks of first mailing

Collaborators and Investigators

• Sponsor: Minnesota Department of Health
• Investigators: Principal Investigator: Jonathan S Slater, PhD, Minnesota Department of Health; Study Director: Christina L Nelson, MS, Minnesota Department of Health

Study record dates

Study Major Dates

• Study Start (Actual): April 23, 2014
• Primary Completion (Actual): September 30, 2014
• Study Completion (Actual): May 10, 2017

Study Registration Dates

• First Submitted: September 1, 2017
• First Submitted That Met QC Criteria: September 5, 2017
• First Posted (Actual): September 8, 2017

Study Record Updates

• Last Update Posted (Actual): September 11, 2017
• Last Update Submitted That Met QC Criteria: September 7, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: cancer screening
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: Innovations2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No