CClinicalTrials.gg
CompletedNCT03275987Updated Sep 11, 2017

Promoting Cancer Screening Among Medicaid Recipients in Minnesota

An interventional study of Mammography direct mail coupled with a financial incentive and Usual care in Colorectal Cancer and Breast Cancer, sponsored by Minnesota Department of Health. Completed at 1 site in United States. Open to participants aged 50 Years to 74 Years. Per ClinicalTrials.gov, last updated 2017-09-11.

Sponsored by Minnesota Department of Health · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
138,554
Allocation
Randomized
Ages
50 Years to 74 Years
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

  • Colorectal Cancer
  • Breast Cancer

Keywords

  • cancer screening
03

Who can participate

Ages eligible
50 Years to 74 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Enrolled in Minnesota Medicaid for at least the prior year

Exclusion criteria

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)
04

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
138,554 participants (actual)

Study arms

  • Experimental
    Mammography treatment

    Mammography direct mail coupled with a financial incentive

    Behavioral: Mammography direct mail coupled with a financial incentive

  • 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 · Behavioral: Usual care

  • Experimental
    Colonoscopy treatment

    Colonoscopy direct mail coupled with a financial incentive

    Behavioral: Colonoscopy direct mail coupled with a financial incentive

  • Active comparator
    Colonoscopy control/delayed intervention

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

    Behavioral: Usual care · Behavioral: Colonoscopy direct mail coupled with a financial incentive

Interventions

  • BehavioralMammography 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.

  • BehavioralUsual care

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

  • BehavioralColonoscopy 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.

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Within 12 weeks of first mailing

06

Study locations

1 site
  • Minnesota Department of Health
    Saint Paul, Minnesota 55164, United States
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03275987
Lead sponsor
Minnesota Department of Health
Responsible party
Jonathan Slater (Chief of Cancer Control Section, Minnesota Department of Health) — Principal investigator
First posted
Sep 8, 2017
Start date
Apr 23, 2014
Primary completion
Sep 30, 2014
Completion
May 10, 2017
Last update
Sep 11, 2017

Study contacts

Jonathan S Slater, PhD
principal investigator · Minnesota Department of Health
Christina L Nelson, MS
study director · Minnesota Department of Health

Oversight

FDA-regulated drug
No
FDA-regulated device
No
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