A Population-based Randomized Trial to Promote Cancer Screening Among Unscreened Medicaid Recipients in Minnesota
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 138,554
- 试验地点
- 2
- 主要终点
- screening mammography or colonoscopy
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 50 Years 至 74 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Enrolled in Minnesota Medicaid for at least the prior year
排除标准
- •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)
研究组 & 干预措施
Mammography treatment
Mammography direct mail coupled with a financial incentive
干预措施: Mammography direct mail coupled with a financial incentive (Behavioral)
Mammography control/delayed intervention
Usual care (for 15 months); Mammography direct mail coupled with financial incentive (after 15 months)
干预措施: Mammography direct mail coupled with a financial incentive (Behavioral)
Mammography control/delayed intervention
Usual care (for 15 months); Mammography direct mail coupled with financial incentive (after 15 months)
干预措施: Usual care (Behavioral)
Colonoscopy treatment
Colonoscopy direct mail coupled with a financial incentive
干预措施: Colonoscopy direct mail coupled with a financial incentive (Behavioral)
Colonoscopy control/delayed intervention
Usual care (for 15 months); Colonoscopy direct mail coupled with financial incentive (after 15 months)
干预措施: Usual care (Behavioral)
Colonoscopy control/delayed intervention
Usual care (for 15 months); Colonoscopy direct mail coupled with financial incentive (after 15 months)
干预措施: Colonoscopy direct mail coupled with a financial incentive (Behavioral)
结局指标
主要结局
screening mammography or colonoscopy
时间窗: 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.
次要结局
未报告次要终点
研究者
Jonathan Slater
Chief of Cancer Control Section
Minnesota Department of Health
