Promoting Cancer Screening Among Medicaid Recipients in Minnesota

NCT ID: NCT03275987

Last Updated: 2017-09-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 138554 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-23
• Study Completion Date: 2017-05-10

Brief Summary

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

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.

Conditions

Colorectal Cancer; Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: DOUBLE

Study Groups

Mammography treatment

Mammography direct mail coupled with a financial incentive

Group Type: EXPERIMENTAL

Mammography direct mail coupled with a financial incentive

Intervention Type: BEHAVIORAL

The intervention groups received innovative and persuasive direct mail materials coupled with an incentive for using their Medicaid benefit to get screened.

Mammography control/delayed intervention

Usual care (for 15 months); Mammography direct mail coupled with financial incentive (after 15 months)

Group Type: ACTIVE_COMPARATOR

Mammography direct mail coupled with a financial incentive

Intervention Type: BEHAVIORAL

The intervention groups received innovative and persuasive direct mail materials coupled with an incentive for using their Medicaid benefit to get screened.

Usual care

Intervention Type: BEHAVIORAL

Group received usual care, and direct mail 15 months after treatment group received intervention.

Colonoscopy treatment

Colonoscopy direct mail coupled with a financial incentive

Group Type: EXPERIMENTAL

Colonoscopy direct mail coupled with a financial incentive

Intervention Type: BEHAVIORAL

The intervention groups received innovative and persuasive direct mail materials coupled with an incentive for using their Medicaid benefit to get screened.

Colonoscopy control/delayed intervention

Usual care (for 15 months); Colonoscopy direct mail coupled with financial incentive (after 15 months)

Group Type: ACTIVE_COMPARATOR

Usual care

Intervention Type: BEHAVIORAL

Group received usual care, and direct mail 15 months after treatment group received intervention.

Colonoscopy direct mail coupled with a financial incentive

Intervention Type: BEHAVIORAL

The intervention groups received innovative and persuasive direct mail materials coupled with an incentive for using their Medicaid benefit to get screened.

Interventions

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.

Intervention Type: BEHAVIORAL

Usual care

Group received usual care, and direct mail 15 months after treatment group received intervention.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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)

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 74 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Minnesota Department of Health

OTHER_GOV

Sponsor Role: lead

Responsible Party

Jonathan Slater

Chief of Cancer Control Section

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jonathan S Slater, PhD

Role: PRINCIPAL_INVESTIGATOR

Minnesota Department of Health

Christina L Nelson, MS

Role: STUDY_DIRECTOR

Minnesota Department of Health

Locations

Minnesota Department of Health

Saint Paul, Minnesota, United States

Countries

United States

Other Identifiers

Innovations2017

Identifier Type: -

Identifier Source: org_study_id