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

ColoRectal Cancer Screening Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03244787
• Other study ID #: 2016P001322
• Status: Completed
• Phase: N/A
• First received: March 21, 2017
• Last updated: March 20, 2018
• Start date: January 2017
• Est. completion date: January 2018

Study information

• Verified date: March 2018
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 380
• Est. completion date: January 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• ColoRectal Cancer Screening
• Colorectal Neoplasms
• Mental Disorders
• Substance-Related Disorders

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients in intervention and control groups who completed any colorectal cancer screening during the six-month study period	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 colonoscopy results) we will perform EMR reviewed of trial participants.	6 months
Primary	Percentage of patients in intervention and control groups who completed any colorectal cancer screening during the six-month study period	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.	6 months
Secondary	As-treated primary outcomes among intervention patients contacted by patient navigator.	Percentage of patients in intervention and control groups who completed colorectal cancer cancer screening stratified by Mental health vs Substance use disorder, language spoken, race and age (<> 65 years) during the study period	1 year
Secondary	Number of cancers (stage) found in the intervention and control group during the study period		1 year
Secondary	Number of polys found in intervention polyps (histology)		1 year