Clinical trial NCT01885351: An Interactive Preventive Health Record to Increase Colorectal Cancer Screening
Official title: An Interactive Preventive Health Record to Increase Colorectal Cancer Screening
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer Screening
Keywords: Colorectal Cancer Screening
Ambulatory Care
Patient-Centered Care
Intervention Studies
Longitudinal Studies
Lead sponsor: Temple University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: Virginia Commonwealth University
First posted: 2013-06-24
Enrollment: 683
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: PREVENTION

Brief summary: This study involves 3 phases that modifies current Interactive Preventative Health Record-Colorectal Cancer Screening (IPHR-CRCS) modules to address each patient's individual colorectal cancer screening (CRCS) knowledge, attitudes, preferences, and test-specific barriers. The study will engage patients, ages 50-75 years who are non-adherent to CRCS, to assess their CRCS test preferences and corresponding test-specific barriers in "real time". Based on patient characteristics (e.g. age, personal and family history, physician CRCS recommendation, CRCS test preferences, top test-specific barriers), tailored messages/videos will appear in the pop-up screens to address/reduce the top patient-reported, test-specific CRCS barriers while incorporating an action plan for CRCS adherence. The investigators hypothesize that modifying the IPHR-CRCS module to address each patient's individual CRCS knowledge, attitudes, preferences, and test-specific barriers will further increase CRCS.


Eligibility criteria: Inclusion Criteria:

* Adults 50-75 years
* Non-adherent to CRCS guidelines (i.e., no FOBT in last year, no sigmoidoscopy or barium enema in last 5 years, and no colonoscopy in last 10 years)
* English-speaking
* Have computer access (e.g. home, work, library)
* Additional eligibility for Phase I: focus group participants will be ineligible for the subsequent prototype testing and cognitive/usability testing interviews
* Additional eligibility for Phase I: prototype testing participants will be ineligible for the cognitive/usability testing interviews
* Additional eligibility for Phase II: Seen in the clinic in the last 2 years

Exclusion Criteria:

* Personal CRC history
* Additional exclusion for Phase III: Patients seen at any clinic participating in Phase II

Primary outcomes:
measure: CRCS adherence provided by the electronic medical record
timeFrame: Phase II: Baseline up to 12 months post randomization
measure: CRCS adherence provided by the electronic medical record
timeFrame: Phase III: Baseline up to 12 months post intervention
Secondary outcomes:
measure: Self-reported CRCS adherence
timeFrame: Phase II: Baseline, 3 months, and 9 months post randomization
measure: EHR Paradata
timeFrame: Phase II: continuous
measure: Psychosocial Constructs
timeFrame: Phase II: Baseline, 3 months, and 9 months post randomization
measure: General and test-specific colorectal cancer screening barriers
timeFrame: Phase II: Baseline, 3 months, and 9 months post randomization
measure: Self-reported CRCS adherence
timeFrame: Phase III: Baseline and 9 months post intervention
measure: EHR Paradata
timeFrame: Phase III: Continuous
measure: Psychosocial Constructs
timeFrame: Phase III: Baseline and 9 months post intervention
measure: General and test-specific colorectal cancer screening barriers
timeFrame: Phase III: Baseline and 9 months post intervention
measure: Feasibility of MyCRCS+ in target setting - patient survey
timeFrame: Phase III: Baseline and 9 months post intervention
Other outcomes:
measure: Development of MyCRCS+ intervention content
timeFrame: Phase I (months 1-17)
Locations:
city: Philadelphia
country: United States
facility: Temple University - General Internal Medicine
state: Pennsylvania
city: Richmond
country: United States
facility: Virginia Ambulatory Care Outcomes Research Network
state: Virginia
Study officials:
affiliation: Temple University and Virginia Commonwealth University
name: Resa M Jones, MPH, PhD
role: PRINCIPAL_INVESTIGATOR
References: