Positive Fit to Colonoscopy: Closing the Gap
ConditionColorectal Cancer Screening
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age45-75
SponsorMassachusetts General Hospital
About this trial
The goals of this proposal are to: (1) identify patient- and system-level determinants of diagnostic colonoscopy after positive FIT; (2) identify patient- and system-level equity-driven implementation strategies for diagnostic colonoscopy after positive FIT matched to determinants; and (3) pilot test patient- and systems-level implementation strategies to increase rate of colonoscopy after positive FIT and determine feasibility and acceptability of strategies using mixed methods
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Individuals aged 45-75
Individuals who are patients at Codman Square Health Center
Individuals that are willing and able to give verbal/written consent
Disqualifiers
Individuals with a personal history of colorectal cancer
Individuals with a family history of colorectal cancer
Individuals with a history of inflammatory bowel disease or high-risk cancer syndrome
Trial population
Codman Square Health Center patients aged 45-75 who do not have a personal or family history of colorectal cancer, inflammatory bowel disease, or a high-risk cancer syndrome. Codman Square Health Center staff ages 18+ that are involved in colorectal cancer screening processes at Codman Square Health Center.
Trial design
Design model
Other
Time perspective
Other
Treatments tested in this trial
Not listed
Trial groups
45 Participants
are grouped into 1 trial groupGroup A: Patients and staff will be recruited from Codman Square Health Center.
Trial outcomes
Primary outcomes
1
Measurement of Acceptability and Feasibility of a validated survey
For our primary outcome, participants will be asked to rate the acceptability and feasibility of implementation strategies using a previously validated instrument, which the investigator previously used with CHC staff. This tool has demonstrated good internal consistency reliability (0.85 for acceptability and 0.89 for feasibility) and similarly good test-retest reliability (correlations: acceptability- 0.80; feasibility - 0.88) and validity in a known groups analysis. There are no cut off numbers for acceptability and feasibility as these are just means but higher scores reflect higher acceptability.
Time frame
From planning to testing and evaluation and assessment of outcomes will be a total of 12 months2
Measurement of Acceptability and Feasibility of semi structure interviews
The investigator will conduct semi structure interviews to further understand participants' perceptions around feasibility and acceptability.
Time frame
From planning to testing and evaluation and assessment of outcomes will be a total of 12 monthsSecondary outcomes
1
Measurement of reach of descriptive statistics
For secondary outcomes, descriptive statistics (relative frequencies, means, variability) will be used to evaluate reach (the number of patients offered CRC screening measured by calculating the number of patients with a FIT order or colonoscopy referral during the pilot testing period).
Time frame
From planning to testing and evaluation and assessment of outcomes will be a total of 12 months2
Measurement of reach of semi structure interviews
The investigator will also conduct semi structure interviews to further understand participants' perceptions around reach.
Time frame
From planning to testing and evaluation and assessment of outcomes will be a total of 12 months3
Measurement of effectiveness using descriptive statistics
For secondary outcomes, descriptive statistics (relative frequencies, means, variability) will be used to evaluate effectiveness (time to CRC screening measured by assessing the difference in the date CRC screening was completed compared to the start date of pilot testing and number screened for CRC pre and post intervention).
Time frame
From planning to testing and evaluation and assessment of outcomes will be a total of 12 months4
Measurement of maintenance using descriptive statistics
For secondary outcomes, descriptive statistics (relative frequencies, means, variability) will be used to evaluate maintenance (percentage of program components maintained).
Time frame
From planning to testing and evaluation and assessment of outcomes will be a total of 12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Massachusetts General Hospital
Lead sponsor
Robert Wood Johnson Foundation
Collaborator
Source ClinicalTrials.gov