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Clinical Trials/NCT03244787
NCT03244787
Completed
Not Applicable

Patient Navigation for Colorectal Cancer Screening for Patients With Mental Illness and/or Substance Use Disorder

Massachusetts General Hospital0 sites380 target enrollmentJanuary 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
ColoRectal Cancer Screening
Sponsor
Massachusetts General Hospital
Enrollment
380
Primary Endpoint
Percentage of patients in intervention and control groups who completed any colorectal cancer screening during the six-month study period
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

The investigators propose to develop, implement, and evaluate a novel Colorectal (CRC) screening patient navigator program for patients with Mental Health (MH) and /or Substance Use Disorder (SUD) receiving care at Massachusetts General Hospital Charlestown. The study will involve randomly assigning eligible patients to early intervention or usual care/delayed intervention groups. The investigators believe this random assignment is ethical because Patient Navigation (PN) is an extremely limited resource, and all patients identified as eligible could not be contacted by the navigators in a short period of time. Thus the investigators will randomly assign access to PN during the study period, and then allow all patients to be navigated and screened after the study period is over. As a result, all eligible patients will be referred for PN, but the timing of the referral will be randomly assigned.

Registry
clinicaltrials.gov
Start Date
January 2017
End Date
January 2018
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Carolina Abuelo

Instructor

Massachusetts General Hospital

Eligibility Criteria

Inclusion Criteria

  • adult patients aged 50-75 years who are not up to date on CRC screening (did not have had CRCs colonoscopy in the last 10 years or sigmoidoscopy in the last 5 years or fecal occult blood within last 12 months)
  • receive care at MGH Charlestown
  • have documented history of MH or SUD in electronic medical record

Exclusion Criteria

  • subsequently identified as having died prior to study intervention
  • patients with total colectomy

Outcomes

Primary Outcomes

Percentage of patients in intervention and control groups who completed any colorectal cancer screening during the six-month study period

Time Frame: 6 months

To obtain the data about colorectal cancer screening we will use billing data from our institution repository. Additionally, and when/if the data is not available (percentage of fecal occult blood test results) we will perform EMR reviewed of trial participants.

Secondary Outcomes

  • Number of polys found in intervention polyps (histology)(1 year)
  • As-treated primary outcomes among intervention patients contacted by patient navigator.(1 year)
  • Number of cancers (stage) found in the intervention and control group during the study period(1 year)

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