Clinical trial NCT02594150: Single Center Randomized Pilot Study Of Colorectal Cancer Screening Outreach
Official title: Single Center Randomized Pilot Study Of Colorectal Cancer Screening Outreach
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2015-11-01
Enrollment: 897
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: A four arm randomized pilot study to assess if the rate of completion of Fecal Immunochemical Test is increased by the addition of financial incentives.

Detailed description: This is a single center 4-arm randomized pilot study to assess if the rate of completion of Fecal Immunochemical Test (FIT) is increased by the addition of financial incentives. Potentially eligible subjects will be identified via a data abstraction by Penn Data Store. We will conduct Electronic Medical Record (EMR) reviews on randomly select patients from the data abstraction using PennChart to confirm eligibility until 1,080 patients are identified. We will then randomize these 1,080 patients to one of four arms during the intervention phase.

* Arm 1: mailed FIT kit (usual care)
* Arm 2: mailed FIT kit + a gift card included in mailing (unconditional fixed incentive)
* Arm 3: mailed FIT kit + guarantee of receiving a gift card if kit is returned within two months (conditional fixed incentive)
* Arm 4: mailed FIT kit + entry in a 1/10 chance lottery to receive a gift card if kit is returned within two months (conditional lottery incentive) All 1,080 subjects will receive the mailed FIT kit. Subjects whose FIT results are not recorded in PennChart will receive a follow-up phone call via Interactive Voice Response (IVR) three weeks after the kit was mailed to the subject. Subjects whose FIT results are not recorded in PennChart will receive a follow-up mailed reminder six weeks after the kit was mailed to the subject. Subjects will receive follow-up regardless of the arm to which they are randomized.

A random sub-sample of 200 subjects will be called at least twelve weeks after the kit was mailed to the subject to complete a questionnaire. Verbal consent will be obtained from this sub-sample. This phone call will occur after the intervention and follow-up phases are completed. Analysis will occur after the sub-sample questionnaire phase is completed.

Eligibility criteria: Inclusion Criteria:

* Between 50 to 75 years old
* Has had at least two visits at Penn Family Care Within the past two years - Due for screening
* Asymptomatic for colorectal cancer (CRC)
* Zip code listed in PennChart as part of the subjects address is within the Philadelphia-Wilmington-Camden Metropolitan Statistical Area
* Have a primary care provider in Penn Family Care

Exclusion Criteria:

* Has had prior colonoscopy within 10 years, sigmoidoscopy within 5 years, and fecal occult blood test (FOBT)/FIT within twelve months of the chart review (We will exclude patients who self-report undergoing any of the above procedures)
* Has a history of CRC
* Has a history of other GI cancer
* Has history of confirmed Inflammatory Bowel Disease (IBD) (e.g. Crohn's disease, ulcerative colitis; Irritable bowel syndrome does not exclude patients)
* Has history of colitis other than Crohn's disease or ulcerative colitis
* Has had a colectomy
* Has a relative that has been diagnosed with CRC
* Has been diagnosed with Lynch Syndrome (i.e. HNPCC)
* Has been diagnosed with Familial Adenomatous Polyposis (FAP)
* Has anemia (iron-deficient or general/unspecified)
* Has history of lower GI bleeding
* Has metastatic (Stage IV) blood or solid tumor cancer
* Has end stage renal disease
* Has had congestive heart failure
* Has dementia
* Has cirrhosis or end stage liver disease
* Has any other condition that, in the opinion of the investigator, excludes the patient from participating in this study

Primary outcomes:
measure: Increase in return rate of completed FIT
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Pennsylvania
name: Shivan Mehta, MD MBA MSHP
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pennsylvania
name: Chyke Doubeni, MD MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mehta SJ, Pepe RS, Gabler NB, Kanneganti M, Reitz C, Saia C, Teel J, Asch DA, Volpp KG, Doubeni CA. Effect of Financial Incentives on Patient Use of Mailed Colorectal Cancer Screening Tests: A Randomized Clinical Trial. JAMA Netw Open. 2019 Mar 1;2(3):e191156. doi: 10.1001/jamanetworkopen.2019.1156.