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Promoting Cancer Screening Among Medicaid Recipients in Minnesota

Primary Purpose

Colorectal Cancer, Breast Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mammography direct mail coupled with a financial incentive
Usual care
Colonoscopy direct mail coupled with a financial incentive
Sponsored by
Minnesota Department of Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Colorectal Cancer focused on measuring cancer screening

Eligibility Criteria

50 Years - 74 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Minnesota Department of Health

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Experimental

Active Comparator

Arm Label

Mammography treatment

Mammography control/delayed intervention

Colonoscopy treatment

Colonoscopy control/delayed intervention

Arm Description

Mammography direct mail coupled with a financial incentive

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

Colonoscopy direct mail coupled with a financial incentive

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
September 1, 2017
Last Updated
September 7, 2017
Sponsor
Minnesota Department of Health
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1. Study Identification

Unique Protocol Identification Number
NCT03275987
Brief Title
Promoting Cancer Screening Among Medicaid Recipients in Minnesota
Official Title
A Population-based Randomized Trial to Promote Cancer Screening Among Unscreened Medicaid Recipients in Minnesota
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
April 23, 2014 (Actual)
Primary Completion Date
September 30, 2014 (Actual)
Study Completion Date
May 10, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Minnesota Department of Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer, Breast Cancer
Keywords
cancer screening

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
138554 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mammography treatment
Arm Type
Experimental
Arm Description
Mammography direct mail coupled with a financial incentive
Arm Title
Mammography control/delayed intervention
Arm Type
Active Comparator
Arm Description
Usual care (for 15 months); Mammography direct mail coupled with financial incentive (after 15 months)
Arm Title
Colonoscopy treatment
Arm Type
Experimental
Arm Description
Colonoscopy direct mail coupled with a financial incentive
Arm Title
Colonoscopy control/delayed intervention
Arm Type
Active Comparator
Arm Description
Usual care (for 15 months); Colonoscopy direct mail coupled with financial incentive (after 15 months)
Intervention Type
Behavioral
Intervention Name(s)
Mammography direct mail coupled with a financial incentive
Intervention Description
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
Intervention Name(s)
Usual care
Intervention Description
Group received usual care, and direct mail 15 months after treatment group received intervention.
Intervention Type
Behavioral
Intervention Name(s)
Colonoscopy direct mail coupled with a financial incentive
Intervention Description
The intervention groups received innovative and persuasive direct mail materials coupled with an incentive for using their Medicaid benefit to get screened.
Primary Outcome Measure Information:
Title
screening mammography or colonoscopy
Description
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

10. Eligibility

Sex
All
Gender Based
Yes
Gender Eligibility Description
Mammography arm was limited to women. Colonoscopy arm included both genders.
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan S Slater, PhD
Organizational Affiliation
Minnesota Department of Health
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Christina L Nelson, MS
Organizational Affiliation
Minnesota Department of Health
Official's Role
Study Director
Facility Information:
Facility Name
Minnesota Department of Health
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55164
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Promoting Cancer Screening Among Medicaid Recipients in Minnesota

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