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

NCT ID: NCT03244787

Last Updated: 2018-03-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 380 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-31
• Study Completion Date: 2018-01-31

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.

Conditions

ColoRectal Cancer Screening

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

patient navigation

PN will contact patients during their visits to health cancer or over the phone. During this initial contact, the PN will educate patients about CRC, screening and explore their barriers to screening. The PN will coordinate scheduling of CRC screening and remind patients about the tests. PN will explain preparation for colonoscopy and whenever feasible, accompany patient to obtain the test. Further interventions may include: reminding the patient about the test, helping with translation, insurance issues, transportation, and overcoming any other system barriers as needed.

Group Type: EXPERIMENTAL

patient navigation

Intervention Type: BEHAVIORAL

Current standard of care is for PNs to work with patients from health centers who are referred by providers. Intervention patients will appear on a PN list without any referral by providers. Control high risk patients will proceed normally and will be eligible to transfer to a PN list after the 6-month study period.

usual care

patients randomly assigned to the control will receive usual care and be eligible for navigation after the study period.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

patient navigation

Current standard of care is for PNs to work with patients from health centers who are referred by providers. Intervention patients will appear on a PN list without any referral by providers. Control high risk patients will proceed normally and will be eligible to transfer to a PN list after the 6-month study period.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Carolina Abuelo

Instructor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sanja Percac Lima, MD

Role: PRINCIPAL_INVESTIGATOR

MGH

Other Identifiers

2016P001322

Identifier Type: -

Identifier Source: org_study_id