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Promoting Cancer Screening Among Medicaid Recipients in Minnesota

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03275987
Recruitment Status : Completed
First Posted : September 8, 2017
Last Update Posted : September 11, 2017
Sponsor:
Information provided by (Responsible Party):
Jonathan Slater, Minnesota Department of Health

Tracking Information
First Submitted Date  ICMJE September 1, 2017
First Posted Date  ICMJE September 8, 2017
Last Update Posted Date September 11, 2017
Actual Study Start Date  ICMJE April 23, 2014
Actual Primary Completion Date September 30, 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 5, 2017)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Promoting Cancer Screening Among Medicaid Recipients in Minnesota
Official Title  ICMJE A Population-based Randomized Trial to Promote Cancer Screening Among Unscreened Medicaid Recipients in Minnesota
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Health Services Research
Condition  ICMJE
  • Colorectal Cancer
  • Breast Cancer
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • Experimental: Mammography treatment
    Mammography direct mail coupled with a financial incentive
    Intervention: 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)
    Interventions:
    • Behavioral: Mammography direct mail coupled with a financial incentive
    • Behavioral: Usual care
  • Experimental: Colonoscopy treatment
    Colonoscopy direct mail coupled with a financial incentive
    Intervention: 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)
    Interventions:
    • Behavioral: Usual care
    • Behavioral: Colonoscopy direct mail coupled with a financial incentive
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 5, 2017)
138554
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 10, 2017
Actual Primary Completion Date September 30, 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Gender Based Eligibility: Yes
Gender Eligibility Description: Mammography arm was limited to women. Colonoscopy arm included both genders.
Ages  ICMJE 50 Years to 74 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03275987
Other Study ID Numbers  ICMJE Innovations2017
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Jonathan Slater, Minnesota Department of Health
Study Sponsor  ICMJE Minnesota Department of Health
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jonathan S Slater, PhD Minnesota Department of Health
Study Director: Christina L Nelson, MS Minnesota Department of Health
PRS Account Minnesota Department of Health
Verification Date September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP