An Interactive Preventive Health Record to Increase Colorectal Cancer Screening

NCT01885351 | Completed

• 3 other identifiers: HM14658R01CA166375-01A1MYCRCS-302259
• Study Type: interventional
• Target: 683
• Locations: 1 country
• Sites: 2

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.

Conditions

Colorectal Cancer Screening

Keywords

Colorectal Cancer Screening; Ambulatory Care; Patient-Centered Care; Intervention Studies; Longitudinal Studies

Outcome Measures

Primary Outcomes (2)

• CRCS adherence provided by the electronic medical record

  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.

  Phase II: Baseline up to 12 months post randomization

• CRCS adherence provided by the electronic medical record

  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.

  Phase III: Baseline up to 12 months post intervention

Secondary Outcomes (9)

• Self-reported CRCS adherence

  Phase II: Baseline, 3 months, and 9 months post randomization

• EHR Paradata

  Phase II: continuous

• Psychosocial Constructs

  Phase II: Baseline, 3 months, and 9 months post randomization

• General and test-specific colorectal cancer screening barriers

  Phase II: Baseline, 3 months, and 9 months post randomization

• Self-reported CRCS adherence

  Phase III: Baseline and 9 months post intervention

Other Outcomes (1)

• Development of MyCRCS+ intervention content

  Phase I (months 1-17)

Study Arms (3)

Phase II: MyCRCS+Prefs

EXPERIMENTAL

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.

Behavioral: MyCRCS+Prefs

Phase II: MyCRCS+Prefs+Barriers

EXPERIMENTAL

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 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

Behavioral: MyCRCS+Prefs+Barriers

Phase II: Usual Care

NO INTERVENTION

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).

Interventions

MyCRCS+Prefs BEHAVIORAL

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.

Phase II: MyCRCS+Prefs

MyCRCS+Prefs+Barriers BEHAVIORAL

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.

Phase II: MyCRCS+Prefs+Barriers

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Personal CRC history

Sponsors & Collaborators

• Temple University: lead
• National Cancer Institute (NCI): collaborator
• Virginia Commonwealth University: collaborator

Study Sites (2)

Temple University - General Internal Medicine

Philadelphia, Pennsylvania, 19122, United States

Location

Virginia Ambulatory Care Outcomes Research Network

Richmond, Virginia, 23298, United States

Location

Study Officials

• Resa M Jones, MPH, PhD

  Temple University and Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2013
• First Posted: June 24, 2013
• Study Start: March 1, 2013
• Primary Completion: July 1, 2020
• Study Completion: August 10, 2020
• Last Updated: December 17, 2020

Record last verified: 2020-12

Locations

US (2)