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Promoting Cancer Screening Among Medicaid Recipients in Minnesota

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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

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

Condition or disease Intervention/treatment Phase
Colorectal Cancer Breast Cancer Behavioral: Mammography direct mail coupled with a financial incentive Behavioral: Usual care Behavioral: Colonoscopy direct mail coupled with a financial incentive Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 138554 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Health Services Research
Official Title: A Population-based Randomized Trial to Promote Cancer Screening Among Unscreened Medicaid Recipients in Minnesota
Actual Study Start Date : April 23, 2014
Actual Primary Completion Date : September 30, 2014
Actual Study Completion Date : May 10, 2017

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Mammography arm was limited to women. Colonoscopy arm included both genders.
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03275987


Locations
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United States, Minnesota
Minnesota Department of Health
Saint Paul, Minnesota, United States, 55164
Sponsors and Collaborators
Minnesota Department of Health
Investigators
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Principal Investigator: Jonathan S Slater, PhD Minnesota Department of Health
Study Director: Christina L Nelson, MS Minnesota Department of Health

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Responsible Party: Jonathan Slater, Chief of Cancer Control Section, Minnesota Department of Health
ClinicalTrials.gov Identifier: NCT03275987     History of Changes
Other Study ID Numbers: Innovations2017
First Posted: September 8, 2017    Key Record Dates
Last Update Posted: September 11, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jonathan Slater, Minnesota Department of Health:
cancer screening
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases