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An Interactive Preventive Health Record to Increase Colorectal Cancer Screening (MyCRCS)

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ClinicalTrials.gov Identifier: NCT01885351
Recruitment Status : Enrolling by invitation
First Posted : June 24, 2013
Last Update Posted : February 4, 2019
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Temple University
Information provided by (Responsible Party):
Virginia Commonwealth University

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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Screening Behavioral: MyCRCS+Prefs Behavioral: MyCRCS+Prefs+Barriers Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 832 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: An Interactive Preventive Health Record to Increase Colorectal Cancer Screening
Study Start Date : August 2013
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Phase II: MyCRCS+Prefs Behavioral: MyCRCS+Prefs

Patients who are identified by the IPHR as study participants will see an attractive link. In the Prefs arm, via question prompt lists, patients will first identify their CRCS preference using previously developed elicitation strategies.

Tailoring will be used to increase salience of information, motivation, communication, and action plans. We envision the Prefs+ arm in its entirety will be 5-7 minutes, but will depend on Phase I formative work. If the patient remains non-adherent, they will receive an e-mail reminder generated by the IPHR (specific text and frequency determined in Phase I). The Prefs content is identical to the preference portion of the Prefs+Barriers arm, which will allow us to assess the incremental benefit of addressing preferences only and the incremental benefit of addressing preferences and barriers.


Experimental: Phase II: MyCRCS+Prefs+Barriers Behavioral: MyCRCS+Prefs+Barriers

Patients who are identified by the IPHR as study participants will see an attractive link. In the Prefs+Barriers arm, via question prompt lists, patients will first identify their CRCS preference using previously developed elicitation strategies, and subsequently based on their test preference determine their top 3-5 test-specific barriers/concerns in "real time".

Tailoring will be used to increase salience of information, motivation, communication, and action plans. We envision the Prefs+Barriers arm in its entirety will be 15-25 minutes, but will depend on Phase I formative work. If the patient remains non-adherent, they will receive an e-mail reminder generated by the IPHR (specific text and frequency determined in Phase I). The Prefs content is identical to the preference portion of the Prefs+Barriers arm, which will allow us to assess the incremental benefit of addressing preferences only and the incremental benefit of addressing preferences and barriers.


No Intervention: Phase II: Usual Care
The IPHR will be programmed so that where the IPHR-CRCS would normally present patients, who based on their demographics and health conditions, with content advising them to seek CRCS and links to third-party sites, they would instead be randomized to receive the usual care (IPHR-CRCS).



Primary Outcome Measures :
  1. CRCS adherence provided by the electronic medical record [ Time Frame: Phase II: Baseline up to 12 months post randomization ]
    Having had ≥1 test (i.e., fecal occult blood test, sigmoidoscopy, colonoscopy and barium enema) within the time frame specified for each procedure will count as adherent CRCS.

  2. CRCS adherence provided by the electronic medical record [ Time Frame: Phase III: Baseline up to 12 months post intervention ]
    Having had ≥1 test (i.e., fecal occult blood test, sigmoidoscopy, colonoscopy and barium enema) within the time frame specified for each procedure will count as adherent CRCS.


Secondary Outcome Measures :
  1. Self-reported CRCS adherence [ Time Frame: Phase II: Baseline, 3 months, and 9 months post randomization ]
    The four NCI-recommended CRCS history questions will be included on the self-report surveys. Respondents will identify the last time they had each test (i.e., fecal occult blood test, sigmoidoscopy, colonoscopy and barium enema). Having had ≥1 test within the time frame specified for each procedure will count as adherent CRCS.

  2. EHR Paradata [ Time Frame: Phase II: continuous ]
    We will track participants' use of the intervention and usual care arms to capture number of log-ins, pages viewed, length of view, links clicked. In addition to elucidating patients' uptake of intervention components, these data can indicate engagement for dose-response analyses or be examined as potential mediators. For Phase II, this data will allow us to assess the timing of intervention reminders to make a decision about what frequency is most appropriate so that we can modify before we begin the feasibility study (phase III).

  3. Psychosocial Constructs [ Time Frame: Phase II: Baseline, 3 months, and 9 months post randomization ]
    Scales (e.g. Decisional conflict, intentions , self-efficacy, perceived susceptibility, worry, etc.) are included in the patient questionnaire, which have good psychometric properties.

  4. General and test-specific colorectal cancer screening barriers [ Time Frame: Phase II: Baseline, 3 months, and 9 months post randomization ]
    A previously validated modality-specific colorectal cancer screening barrier instrument will be used. The FOBT-specific scale includes 19 questions relating to barriers for fecal occult blood test, and the colonoscopy-specific scale includes 21 questions relating barriers to colonoscopy. All items are measured on a 5-point Likert-type scale, with 5 representing greater barrier endorsement. Items are summated to create continuous scale scores (range: FOBT=19-95; colonoscopy=21-105).

  5. Self-reported CRCS adherence [ Time Frame: Phase III: Baseline and 9 months post intervention ]
    The four NCI-recommended CRCS history questions will be included on the self-report surveys. Respondents will identify the last time they had each test (i.e., fecal occult blood test, sigmoidoscopy, colonoscopy and barium enema). Having had ≥1 test within the time frame specified for each procedure will count as adherent CRCS.

  6. EHR Paradata [ Time Frame: Phase III: Continuous ]
    We will track participants' use of the intervention and usual care arms to capture number of log-ins, pages viewed, length of view, links clicked. In addition to elucidating patients' uptake of intervention components, these data can indicate engagement for dose-response analyses or be examined as potential mediators. For Phase II, this data will allow us to assess the timing of intervention reminders to make a decision about what frequency is most appropriate so that we can modify before we begin the feasibility study (phase III).

  7. Psychosocial Constructs [ Time Frame: Phase III: Baseline and 9 months post intervention ]
    Scales (e.g. Decisional conflict, intentions , self-efficacy, perceived susceptibility, worry, etc.) are included in the patient questionnaire, which have good psychometric properties.

  8. General and test-specific colorectal cancer screening barriers [ Time Frame: Phase III: Baseline and 9 months post intervention ]
    A previously validated modality-specific colorectal cancer screening barrier instrument will be used. The FOBT-specific scale includes 19 questions relating to barriers for fecal occult blood test, and the colonoscopy-specific scale includes 21 questions relating barriers to colonoscopy. All items are measured on a 5-point Likert-type scale, with 5 representing greater barrier endorsement. Items are summated to create continuous scale scores (range: FOBT=19-95; colonoscopy=21-105).

  9. Feasibility of MyCRCS+ in target setting - patient survey [ Time Frame: Phase III: Baseline and 9 months post intervention ]

    Phase III is a feasibility study to determine among other things, implementation in the "real world" setting. The outcomes we propose to measure are defined by the RE-AIM model. Specifically, we selected four essential elements pertaining to the feasibility of fielding MyCRCS+: Reach, Effectiveness, Implementation, and Maintenance.

    The patient survey will include key questions related to intervention reach and potential future implementation adaptations addressing patient awareness and perception of the practices' MyCRCS+ integration strategies.Surveys will assess: patients' awareness of MyCRCS+, how they learned about it, what they liked or disliked about how practices promoted and used MyCRCS+; to what extent they used the MyCRCS+, the factors that influenced use, facilitators and barriers to both using and acting on MyCRCS+ recommendations; anxiety and worry; and quality of life (QOL).



Other Outcome Measures:
  1. Development of MyCRCS+ intervention content [ Time Frame: Phase I (months 1-17) ]
    Develop and pretest MyCRCS+, which focuses on integrating patient CRCS preferences and test-specific barriers in an interactive web-based intervention. Answer the question: What intervention content and reminder content, packaging and frequency are acceptable to patients?



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Ages Eligible for Study:   50 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01885351


Locations
United States, Pennsylvania
Temple University - General Internal Medicine
Philadelphia, Pennsylvania, United States, 19122
United States, Virginia
Virginia Ambulatory Care Outcomes Research Network
Richmond, Virginia, United States, 23298
Sponsors and Collaborators
Virginia Commonwealth University
National Cancer Institute (NCI)
Temple University
Investigators
Principal Investigator: Resa M Jones, MPH, PhD Temple University and Virginia Commonwealth University

Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT01885351     History of Changes
Other Study ID Numbers: HM14658
R01CA166375-01A1 ( U.S. NIH Grant/Contract )
MYCRCS-302259 ( Other Identifier: Virginia Commonwealth University )
First Posted: June 24, 2013    Key Record Dates
Last Update Posted: February 4, 2019
Last Verified: January 2019

Keywords provided by Virginia Commonwealth University:
Colorectal Cancer Screening
Ambulatory Care
Patient-Centered Care
Intervention Studies
Longitudinal Studies

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases