Colorectal CancerNCT03275987
Promoting Cancer Screening Among Medicaid Recipients in Minnesota
A study testing Mammography direct mail coupled with a financial incentive and Colonoscopy direct mail coupled with a financial incentive in people with Colorectal Cancer and Breast Cancer, run by Minnesota Department of Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 74 years
- Conditions the study is for
- Colorectal Cancer, Breast Cancer
- What is being tested?
- Mammography direct mail coupled with a financial incentive and Colonoscopy direct mail coupled with a financial incentive
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138,554 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Apr 2014to 10 May 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Enrolled in Minnesota Medicaid for at least the prior year
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Minnesota Department of Health
Saint Paul, Minnesota, 55164
About this study
Official title: A Population-based Randomized Trial to Promote Cancer Screening Among Unscreened Medicaid Recipients in Minnesota
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.
- Conditions
- Colorectal Cancer, Breast Cancer
- Being tested
- Mammography direct mail coupled with a financial incentive, Usual care, Colonoscopy direct mail coupled with a financial incentive
- Keywords
- cancer screening
- Medical subject headings
- Colorectal Neoplasms, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mammography direct mail coupled with a financial incentiveBehavioural
The intervention groups received innovative and persuasive direct mail materials coupled with an incentive for using their Medicaid benefit to get screened.
Usual careBehavioural
Group received usual care, and direct mail 15 months after treatment group received intervention.
Colonoscopy direct mail coupled with a financial incentiveBehavioural
The intervention groups received innovative and persuasive direct mail materials coupled with an incentive for using their Medicaid benefit to get screened.
| Study group | Role | What they receive |
|---|---|---|
| Mammography treatment | Experimental | Mammography direct mail coupled with a financial incentive Receives: Behavioral: Mammography direct mail coupled with a financial incentive |
| Mammography control/delayed intervention | Active comparator | Usual care (for 15 months); Mammography direct mail coupled with financial incentive (after 15 months) Receives: Behavioral: Mammography direct mail coupled with a financial incentive; Behavioral: Usual care |
| Colonoscopy treatment | Experimental | Colonoscopy direct mail coupled with a financial incentive Receives: Behavioral: Colonoscopy direct mail coupled with a financial incentive |
| Colonoscopy control/delayed intervention | Active comparator | Usual care (for 15 months); Colonoscopy direct mail coupled with financial incentive (after 15 months) Receives: Behavioral: Usual care; Behavioral: Colonoscopy direct mail coupled with a financial incentive |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 12 weeks of first mailing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2017
- Study start23 Apr 2014
- Primary completion30 Sep 2014
- Study completion10 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 138,554 participants (actual)
Sponsor and investigators
- Lead sponsor
- Minnesota Department of Health
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Jonathan Slater, Minnesota Department of Health
- Investigators
- Jonathan S Slater, PhD, Principal investigator, Minnesota Department of HealthChristina L Nelson, MS, Study director, Minnesota Department of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03275987
- Sponsor's protocol ID
- Innovations2017
- Status last verified
- Sep 2017
- First submitted
- 1 Sep 2017
- Last updated
- 11 Sep 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Population-based Randomized Trial to Promote Cancer Screening Among Unscreened Medicaid Recipients in Minnesota
- ClinicalTrials.gov ID
- NCT03275987
- Acronym / sponsor ID
- Innovations2017
- Conditions
- Colorectal Cancer, Breast Cancer
- Keywords
- cancer screening
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 138,554 participants (actual)
- Lead sponsor
- Minnesota Department of HealthOther government
- Study start
- 23 Apr 2014 (actual)
- Primary completion
- 30 Sep 2014 (actual)
- Study completion
- 10 May 2017 (actual)
- First posted
- 8 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Mammography treatment | Experimental | Behavioral: Mammography direct mail coupled with a financial incentiveMammography direct mail coupled with a financial incentive |
| Mammography control/delayed intervention | Active comparator | Behavioral: Mammography direct mail coupled with a financial incentive, Behavioral: Usual careUsual care (for 15 months); Mammography direct mail coupled with financial incentive (after 15 months) |
| Colonoscopy treatment | Experimental | Behavioral: Colonoscopy direct mail coupled with a financial incentiveColonoscopy direct mail coupled with a financial incentive |
| Colonoscopy control/delayed intervention | Active comparator | Behavioral: Usual care, Behavioral: Colonoscopy direct mail coupled with a financial incentiveUsual care (for 15 months); Colonoscopy direct mail coupled with financial incentive (after 15 months) |
Who may qualify
- Ages
- 50 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Enrolled in Minnesota Medicaid for at least the prior year
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mammography direct mail coupled with a financial incentiveThe intervention groups received innovative and persuasive direct mail materials coupled with an incentive for using their Medicaid benefit to get screened. | Behavioural | Mammography control/delayed intervention, Mammography treatment |
| Usual careGroup received usual care, and direct mail 15 months after treatment group received intervention. | Behavioural | Colonoscopy control/delayed intervention, Mammography control/delayed intervention |
| Colonoscopy direct mail coupled with a financial incentiveThe intervention groups received innovative and persuasive direct mail materials coupled with an incentive for using their Medicaid benefit to get screened. | Behavioural | Colonoscopy control/delayed intervention, Colonoscopy treatment |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonathan S Slater, PhD principal investigator
Minnesota Department of Health
Christina L Nelson, MS study director
Minnesota Department of Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mammography direct mail coupled with a financial incentive and Colonoscopy direct mail coupled with a financial incentive in people with Colorectal Cancer and Breast Cancer, run by Minnesota Department of Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
screening mammography or colonoscopy (time frame: Within 12 weeks of first mailing). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2017.