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Screening More Patients for Colorectal Cancer Through Adapting and Refining Targeted Evidence-Based Interventions in Rural Settings, SMARTER CRC (SMARTER CRC)

Primary Purpose

Colorectal Carcinoma

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Fecal Immunochemical Test
Interview
Patient Navigation
Sponsored by
OHSU Knight Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Colorectal Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • CCOs/CCO STAFF: Serving a majority of counties that are predominantly rural based on 2010 Rural-Urban Commuting Area (RUCA) codes (codes 4-10)
  • CCOs/CCO STAFF: Willing to participate in data collection activities (e.g., producing claims data, interviews)
  • CLINICS: Clinics will be eligible for the cluster randomization if there are 30 or more patients eligible for screening
  • CLINICS: Are classified as rural according to RUCA (Codes 4-10) or Oregon Office of Rural Health designations
  • CLINICS: Are served by CCOs agreeing to participate in the project
  • CLINICS: Willing to implement the intervention into their clinic for the study
  • CLINIC STAFF/PROVIDERS: Employed as a clinician or ancillary staff member in a participating clinic
  • CLINIC STAFF/PROVIDERS: Willing to participate in data collection activities (e.g., interviews, observation, surveys)
  • PATIENTS: Attributed to participating clinic
  • PATIENTS: Are enrolled in Medicaid or dual eligible
  • PATIENTS: Eligible for colorectal cancer (CRC) screening
  • PATIENTS: For the subset of patients that will be invited to participate in key informant interviews, a 5th eligibility criteria is consented to participate
  • COMMUNITY OR REGIONAL/ORGANIZATIONAL PARTNERS: (Includes endoscopy providers, community-based outreach workers, or leaders from regional or national organizations who participate in the pilot, pragmatic trial, or scale-up study)
  • COMMUNITY OR REGIONAL/ORGANIZATIONAL PARTNERS: Involved in study activities (training, care delivery)
  • COMMUNITY OR REGIONAL/ORGANIZATIONAL PARTNERS: Willing to participate in data collection activities (e.g., trainings, interviews, surveys)
  • Elderly - Yes - we anticipate that a limited number of clinic and CCO staff, or community organization representatives may be elderly; we limit our patient recruitment to those aged 45-75
  • Rural - Yes
  • Inner city - No
  • Low income - Yes
  • Disabled - Yes
  • Chronic care - Yes
  • End of life - Yes - This is possible, but we predict limited numbers because of the types of individuals we are recruiting: clinic and CCO staff, and patients who are not currently in hospice care
  • Minorities - Yes

Exclusion Criteria:

  • CLINICS: Clinics are excluded if they have current or ongoing participating in other mailed fecal testing research projects in the Medicaid population
  • PATIENTS: Are current for screening
  • PATIENTS: Comorbid conditions that make patients poor candidates for screening based on clinical judgment (e.g., end-stage renal disease, enrollment in hospice)
  • PATIENTS: Are not an established patient or for other reasons documented by the clinics
  • All patients that we recruit will be at least 45 years of age or older

Sites / Locations

  • OHSU Knight Cancer InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

SMARTER CRC Intervention Year 1

SMARTER CRC Intervention Year 2

Arm Description

In year 1, patients receive mailed FITs from CCO, screening reminders from clinics, and patient navigation as appropriate; Health record data collected.

In year 2, patients receive mailed FITs from CCO, screening reminders from clinics, and patient navigation as appropriate; Health record data collected.

Outcomes

Primary Outcome Measures

Likelihood of any colorectal cancer (CRC) screening (for study-eligible patients)
Will use claims and vendor data to determine whether or not the patient completed CRC screening (i.e., fecal testing, FIT-DNA, sigmoidoscopy, CT colonography, or colonoscopy). To assess effectiveness of CRC screening completion, will use the generalized form of hierarchical linear model (binomial distribution with logit link) to account for clustering of patients within clinics and the assignment to arm at the clinic level.

Secondary Outcome Measures

Completion of testing types (fecal testing, FIT-DNA, CT Colonography, Colonoscopy, Flex Sigmoidoscopy) and % completion
Will use claims and vendor data for calculating whether or not the patient completed each different type of screening.
Rate of CRC screening among the study-eligible population (by clinic)
Will use claims and vendor data for calculating CRC screening rates in clinics. For each clinic, N completed CRC screening / N eligible
Time to screening from study-eligible patient list pull
Days from study-eligible patient list pull to return of FIT or completion of other screening modality (colonoscopy, flex, FIT-DNA). Number of days at individual level.
FIT Results
Results of the completed FITs
Patient Navigation Trainings (Intervention group)
Clinic participation (i.e., attendance count and staff roles) in patient navigation training.
Patient Navigation completed (Intervention group)
Patient navigation implemented = one or more live phone contact with the patient (binary at the individual level).
Follow-up colonoscopy completion
The percentage of patients with abnormal FIT who completed follow-up colonoscopy.
Time to colonoscopy from abnormal FIT result
Days from abnormal FIT result to completion of follow-up colonoscopy. Number of days at the individual level.
Adenomas or cancers detected
Whether or not eligible patient had an adenoma or cancer detected. Binary at individual level.
Adaptations to core program components made by payer or clinic
Key informant interviews and practice facilitator field notes based on the FRAME framework for tracking adaptations will be used to identify and qualitatively assess adaptations.
Key Implementation Factors
Qualitative key informant interviews with patient, clinic, and payer stakeholders to identify implementation strategies and factors relevant to rural context. Guided by Consolidated Framework for Implementation Research (CFIR) and the Expert Recommendations for Implementing Change (ERIC) classification.
Colonoscopy referral
For each clinic, the percent of patients who receive a referral to colonoscopy. Proportion at the clinic level.

Full Information

First Posted
May 12, 2021
Last Updated
July 17, 2023
Sponsor
OHSU Knight Cancer Institute
Collaborators
National Cancer Institute (NCI), Oregon Health and Science University
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1. Study Identification

Unique Protocol Identification Number
NCT04890054
Brief Title
Screening More Patients for Colorectal Cancer Through Adapting and Refining Targeted Evidence-Based Interventions in Rural Settings, SMARTER CRC
Acronym
SMARTER CRC
Official Title
Screening More Patients for CRC Through Adapting and Refining Targeted Evidence-Based Interventions in Rural Settings (SMARTER CRC)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 14, 2021 (Actual)
Primary Completion Date
August 31, 2024 (Anticipated)
Study Completion Date
August 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
OHSU Knight Cancer Institute
Collaborators
National Cancer Institute (NCI), Oregon Health and Science University

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 collects information to provide a model for how to rapidly adapt and scale-up multilevel interventions through clinic-health plan partnerships to reduce the burden of colorectal cancer (CRC) on the United states population. This study may improve colorectal cancer screening rates, follow-up colonoscopy, and referral to care in rural Medicaid patients.
Detailed Description
PRIMARY OBJECTIVE: I. Adapt, pilot, then test the implementation and scale-up of targeted direct mail and patient navigation programs. OUTLINE: This is an implementation-effectiveness trial of direct mail outreach and patient navigation intervention to improve rates of CRC screening. Eligible patients will be mailed a fecal immunochemical test (FIT). The mailed FIT and patient navigation interventions are a part of standard care and are carried out by the Medicaid health plan or clinic. Outcomes are tracked using reports from direct mail vendors, claims data from participating Medicaid health plans, clinic data from the electronic health record, chart review, and data from a REDCap database. The hypotheses will be tested using a two-arm cluster randomized trial design. Participating clinics will be randomized into two groups: Intervention and Usual Care. Medicaid health plans/ Coordinated care organizations (CCO) and clinic leadership participate in interviews and complete surveys. The primary effectiveness outcome of this study is CRC screening likelihood in eligible Medicaid patients in intervention and control clinics at 6 months. Data will be collected at 6 time points: baseline, 6-months, 12-months, 18-months, 24-months, and 36-months. Implementation outcomes and adaptations will be evaluated through interviews with clinic staff, patients, and CCO partners. Clinic staff in various roles related to the program (e.g., outreach workers, patient navigators, quality improvement leads) complete surveys and participate in interviews and observations at baseline, 6-9 months (post-implementation) and at approximately 12 months later, to assess clinic/health system level factors that may influence outcomes. Patients participate in interviews to explore patient experiences with the program. Regional and Organizational partners: CCO leaders, endoscopy providers (e.g., gastrointestinal specialists, general surgeons, primary care clinicians), and community organizations also participate in interviews.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Carcinoma

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
17688 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SMARTER CRC Intervention Year 1
Arm Type
Active Comparator
Arm Description
In year 1, patients receive mailed FITs from CCO, screening reminders from clinics, and patient navigation as appropriate; Health record data collected.
Arm Title
SMARTER CRC Intervention Year 2
Arm Type
Active Comparator
Arm Description
In year 2, patients receive mailed FITs from CCO, screening reminders from clinics, and patient navigation as appropriate; Health record data collected.
Intervention Type
Other
Intervention Name(s)
Fecal Immunochemical Test
Other Intervention Name(s)
FIT, iFOBT, immunoassay fecal occult blood test, immunochemical fecal occult blood test, Immunochemical FOBT, immunologic fecal occult blood test
Intervention Description
Patients due for CRC screening are mailed a FIT test by the clinic or health plan
Intervention Type
Other
Intervention Name(s)
Interview
Intervention Description
Participate in interviews to evaluate the implementation of the mailed FIT and patient navigation programs by the clinics and regional organizations
Intervention Type
Behavioral
Intervention Name(s)
Patient Navigation
Other Intervention Name(s)
Patient Navigator Program
Intervention Description
Clinic staff are trained in Navigation, patients with an abnormal FIT are contacted about colonoscopy by patient navigators
Primary Outcome Measure Information:
Title
Likelihood of any colorectal cancer (CRC) screening (for study-eligible patients)
Description
Will use claims and vendor data to determine whether or not the patient completed CRC screening (i.e., fecal testing, FIT-DNA, sigmoidoscopy, CT colonography, or colonoscopy). To assess effectiveness of CRC screening completion, will use the generalized form of hierarchical linear model (binomial distribution with logit link) to account for clustering of patients within clinics and the assignment to arm at the clinic level.
Time Frame
Primary outcome at 6 months following CCO eligible patient list pull date
Secondary Outcome Measure Information:
Title
Completion of testing types (fecal testing, FIT-DNA, CT Colonography, Colonoscopy, Flex Sigmoidoscopy) and % completion
Description
Will use claims and vendor data for calculating whether or not the patient completed each different type of screening.
Time Frame
Up to 12 months
Title
Rate of CRC screening among the study-eligible population (by clinic)
Description
Will use claims and vendor data for calculating CRC screening rates in clinics. For each clinic, N completed CRC screening / N eligible
Time Frame
6 months
Title
Time to screening from study-eligible patient list pull
Description
Days from study-eligible patient list pull to return of FIT or completion of other screening modality (colonoscopy, flex, FIT-DNA). Number of days at individual level.
Time Frame
Up to 12 months
Title
FIT Results
Description
Results of the completed FITs
Time Frame
6 months
Title
Patient Navigation Trainings (Intervention group)
Description
Clinic participation (i.e., attendance count and staff roles) in patient navigation training.
Time Frame
Up to 12 months
Title
Patient Navigation completed (Intervention group)
Description
Patient navigation implemented = one or more live phone contact with the patient (binary at the individual level).
Time Frame
Up to 12 months
Title
Follow-up colonoscopy completion
Description
The percentage of patients with abnormal FIT who completed follow-up colonoscopy.
Time Frame
Up to 12 months
Title
Time to colonoscopy from abnormal FIT result
Description
Days from abnormal FIT result to completion of follow-up colonoscopy. Number of days at the individual level.
Time Frame
Up to 12 months
Title
Adenomas or cancers detected
Description
Whether or not eligible patient had an adenoma or cancer detected. Binary at individual level.
Time Frame
Up to 12 months
Title
Adaptations to core program components made by payer or clinic
Description
Key informant interviews and practice facilitator field notes based on the FRAME framework for tracking adaptations will be used to identify and qualitatively assess adaptations.
Time Frame
Up to 36 months
Title
Key Implementation Factors
Description
Qualitative key informant interviews with patient, clinic, and payer stakeholders to identify implementation strategies and factors relevant to rural context. Guided by Consolidated Framework for Implementation Research (CFIR) and the Expert Recommendations for Implementing Change (ERIC) classification.
Time Frame
Up to 36 months
Title
Colonoscopy referral
Description
For each clinic, the percent of patients who receive a referral to colonoscopy. Proportion at the clinic level.
Time Frame
Up to 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: CCOs/CCO STAFF: Serving a majority of counties that are predominantly rural based on 2010 Rural-Urban Commuting Area (RUCA) codes (codes 4-10) CCOs/CCO STAFF: Willing to participate in data collection activities (e.g., producing claims data, interviews) CLINICS: Clinics will be eligible for the cluster randomization if there are 30 or more patients eligible for screening CLINICS: Are classified as rural according to RUCA (Codes 4-10) or Oregon Office of Rural Health designations CLINICS: Are served by CCOs agreeing to participate in the project CLINICS: Willing to implement the intervention into their clinic for the study CLINIC STAFF/PROVIDERS: Employed as a clinician or ancillary staff member in a participating clinic CLINIC STAFF/PROVIDERS: Willing to participate in data collection activities (e.g., interviews, observation, surveys) PATIENTS: Attributed to participating clinic PATIENTS: Are enrolled in Medicaid or dual eligible PATIENTS: Eligible for colorectal cancer (CRC) screening PATIENTS: For the subset of patients that will be invited to participate in key informant interviews, a 5th eligibility criteria is consented to participate COMMUNITY OR REGIONAL/ORGANIZATIONAL PARTNERS: (Includes endoscopy providers, community-based outreach workers, or leaders from regional or national organizations who participate in the pilot, pragmatic trial, or scale-up study) COMMUNITY OR REGIONAL/ORGANIZATIONAL PARTNERS: Involved in study activities (training, care delivery) COMMUNITY OR REGIONAL/ORGANIZATIONAL PARTNERS: Willing to participate in data collection activities (e.g., trainings, interviews, surveys) Elderly - Yes - we anticipate that a limited number of clinic and CCO staff, or community organization representatives may be elderly; we limit our patient recruitment to those aged 45-75 Rural - Yes Inner city - No Low income - Yes Disabled - Yes Chronic care - Yes End of life - Yes - This is possible, but we predict limited numbers because of the types of individuals we are recruiting: clinic and CCO staff, and patients who are not currently in hospice care Minorities - Yes Exclusion Criteria: CLINICS: Clinics are excluded if they have current or ongoing participating in other mailed fecal testing research projects in the Medicaid population PATIENTS: Are current for screening PATIENTS: Comorbid conditions that make patients poor candidates for screening based on clinical judgment (e.g., end-stage renal disease, enrollment in hospice) PATIENTS: Are not an established patient or for other reasons documented by the clinics All patients that we recruit will be at least 45 years of age or older
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jennifer Coury, MA
Phone
503-494-6343
Email
smartercrc@ohsu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Melinda Davis, PhD
Organizational Affiliation
OHSU Knight Cancer Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gloria Coronado, PhD
Organizational Affiliation
Kaiser Permanente
Official's Role
Principal Investigator
Facility Information:
Facility Name
OHSU Knight Cancer Institute
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Melinda Davis, PhD
Phone
503-494-4365
First Name & Middle Initial & Last Name & Degree
Melinda Davis, PhD

12. IPD Sharing Statement

Citations:
PubMed Identifier
35418107
Citation
Coronado GD, Leo MC, Ramsey K, Coury J, Petrik AF, Patzel M, Kenzie ES, Thompson JH, Brodt E, Mummadi R, Elder N, Davis MM. Mailed fecal testing and patient navigation versus usual care to improve rates of colorectal cancer screening and follow-up colonoscopy in rural Medicaid enrollees: a cluster-randomized controlled trial. Implement Sci Commun. 2022 Apr 13;3(1):42. doi: 10.1186/s43058-022-00285-3.
Results Reference
derived

Learn more about this trial

Screening More Patients for Colorectal Cancer Through Adapting and Refining Targeted Evidence-Based Interventions in Rural Settings, SMARTER CRC

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