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OpenTrials
Completed

NCT Number: NCT03275987

Promoting Cancer Screening Among 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

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Key information

Age range

50 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Minnesota Department of Health

Saint Paul, Minnesota, 55164, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Mammography direct mail coupled with a financial incentive

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

Behavioral

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

Colonoscopy direct mail coupled with a financial incentive

Behavioral

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

Primary outcomes

  1. screening mammography or colonoscopy

    Time frame: Within 12 weeks of first mailing

    Evidence of a mammogram received after implementation of the intervention, based on presence of CPT codes in Medicaid claims data set.

Sponsors and collaborators

Lead sponsor

Minnesota Department of Health

Other Gov

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2014
Study completion
2017
First posted
Sep 8, 2017
Registry last updated
Sep 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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