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

Primary Purpose

Colorectal Cancer Screening

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MyCRCS+Prefs
MyCRCS+Prefs+Barriers
Sponsored by
Temple University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Colorectal Cancer Screening focused on measuring Colorectal Cancer Screening, Ambulatory Care, Patient-Centered Care, Intervention Studies, Longitudinal Studies

Eligibility Criteria

50 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Temple University - General Internal Medicine
  • Virginia Ambulatory Care Outcomes Research Network

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Phase II: MyCRCS+Prefs

Phase II: MyCRCS+Prefs+Barriers

Phase II: Usual Care

Arm Description

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.

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

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).

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Self-reported CRCS adherence
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.
EHR Paradata
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).
Psychosocial Constructs
Scales (e.g. Decisional conflict, intentions , self-efficacy, perceived susceptibility, worry, etc.) are included in the patient questionnaire, which have good psychometric properties.
General and test-specific colorectal cancer screening barriers
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).
Self-reported CRCS adherence
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.
EHR Paradata
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).
Psychosocial Constructs
Scales (e.g. Decisional conflict, intentions , self-efficacy, perceived susceptibility, worry, etc.) are included in the patient questionnaire, which have good psychometric properties.
General and test-specific colorectal cancer screening barriers
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).
Feasibility of MyCRCS+ in target setting - patient survey
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).

Full Information

First Posted
April 23, 2013
Last Updated
December 14, 2020
Sponsor
Temple University
Collaborators
National Cancer Institute (NCI), Virginia Commonwealth University
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1. Study Identification

Unique Protocol Identification Number
NCT01885351
Brief Title
An Interactive Preventive Health Record to Increase Colorectal Cancer Screening
Acronym
MyCRCS
Official Title
An Interactive Preventive Health Record to Increase Colorectal Cancer Screening
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
March 1, 2013 (Actual)
Primary Completion Date
July 2020 (Actual)
Study Completion Date
August 10, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Temple University
Collaborators
National Cancer Institute (NCI), Virginia Commonwealth University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer Screening
Keywords
Colorectal Cancer Screening, Ambulatory Care, Patient-Centered Care, Intervention Studies, Longitudinal Studies

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
683 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Phase II: MyCRCS+Prefs
Arm Type
Experimental
Arm Description
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.
Arm Title
Phase II: MyCRCS+Prefs+Barriers
Arm Type
Experimental
Arm Description
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
Arm Title
Phase II: Usual Care
Arm Type
No Intervention
Arm Description
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).
Intervention Type
Behavioral
Intervention Name(s)
MyCRCS+Prefs
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
MyCRCS+Prefs+Barriers
Intervention Description
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.
Primary Outcome Measure Information:
Title
CRCS adherence provided by the electronic medical record
Description
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.
Time Frame
Phase II: Baseline up to 12 months post randomization
Title
CRCS adherence provided by the electronic medical record
Description
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.
Time Frame
Phase III: Baseline up to 12 months post intervention
Secondary Outcome Measure Information:
Title
Self-reported CRCS adherence
Description
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.
Time Frame
Phase II: Baseline, 3 months, and 9 months post randomization
Title
EHR Paradata
Description
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).
Time Frame
Phase II: continuous
Title
Psychosocial Constructs
Description
Scales (e.g. Decisional conflict, intentions , self-efficacy, perceived susceptibility, worry, etc.) are included in the patient questionnaire, which have good psychometric properties.
Time Frame
Phase II: Baseline, 3 months, and 9 months post randomization
Title
General and test-specific colorectal cancer screening barriers
Description
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).
Time Frame
Phase II: Baseline, 3 months, and 9 months post randomization
Title
Self-reported CRCS adherence
Description
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.
Time Frame
Phase III: Baseline and 9 months post intervention
Title
EHR Paradata
Description
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).
Time Frame
Phase III: Continuous
Title
Psychosocial Constructs
Description
Scales (e.g. Decisional conflict, intentions , self-efficacy, perceived susceptibility, worry, etc.) are included in the patient questionnaire, which have good psychometric properties.
Time Frame
Phase III: Baseline and 9 months post intervention
Title
General and test-specific colorectal cancer screening barriers
Description
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).
Time Frame
Phase III: Baseline and 9 months post intervention
Title
Feasibility of MyCRCS+ in target setting - patient survey
Description
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).
Time Frame
Phase III: Baseline and 9 months post intervention
Other Pre-specified Outcome Measures:
Title
Development of MyCRCS+ intervention content
Description
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?
Time Frame
Phase I (months 1-17)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Resa M Jones, MPH, PhD
Organizational Affiliation
Temple University and Virginia Commonwealth University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Temple University - General Internal Medicine
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19122
Country
United States
Facility Name
Virginia Ambulatory Care Outcomes Research Network
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States

12. IPD Sharing Statement

Learn more about this trial

An Interactive Preventive Health Record to Increase Colorectal Cancer Screening

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