Colorectal NeoplasmsEPIICNCT00810771
Evaluating a Preference-based Intervention for Increasing Colorectal Cancer Screening
A study testing Standard Information and Preference-tailored Information in people with Colorectal Neoplasms, run by US Department of Veterans Affairs at 2 sites in United States.
Trial summary
The goal of this study is to evaluate whether an educational tool about colorectal cancer (CRC) completed on a computer that helps patients clarify their CRC screening preferences will lead to increased screening rates for CRC compared to standard information delivered via computer. Read more about this study
- Who is it for?
- Ages 50 to 78 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Neoplasms
- What is being tested?
- Standard Information and Preference-tailored Information
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 466 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2009to Aug 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 78 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Clinic appointment at Ann Arbor or Pittsburgh VA during recruitment period.
- Age 50-78.
- Not up to date with CRC screening according to VA and USPSTF guidelines.
- At average risk for CRC (no history of CRC, adenomatous colon polyps, inflammatory bowel disease, and no family history of CRC).
- Has current address and telephone number listed in medical record.
Who cannot join
- DNR/DNI code status.
- Metastatic cancer.
- Stage D congestive heart failure.
- Severe COPD.
- Coronary artery disease (CAD) and MI within one year or CAD and unstable angina within 6 months.
- Dementia.
Show all 12Show fewer
- Inability to conduct activities of daily living.
- Life expectancy less than one year.
- Other - anything else that limits CRC screening options.
- Scheduled for a colonoscopy, sigmoidoscopy, DCBE, or CTC.
- prior participation in this study
- unable to contact after 2 introductory letters (at least 6 months apart)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
VA Ann Arbor Healthcare System
Ann Arbor, Michigan, 48113-0170
Center for Health Equity Research and Promotion
Pittsburgh, Pennsylvania, 15240
About this study
Official title: Evaluating a Preference-based Intervention for Increasing CRC Screening
The goal of this study is to evaluate whether an educational tool about colorectal cancer (CRC) completed on a computer that helps patients clarify their CRC screening preferences will lead to increased screening rates for CRC compared to standard information delivered via computer.
Read the detailed description
Background: Colorectal cancer (CRC) is a significant and preventable disease, yet CRC screening remains one of the lowest quality indicators in the VA healthcare system. Moreover, a recent VA directive recommends that CRC screening among Veterans should be based on their preferences, given that there is insufficient evidence to support recommending one test. However the impact of such a preference-based strategy on important outcomes, including screening adherence and cost, is unknown.
Objectives: The broad hypothesis of the proposed study is that helping Veterans clarify their CRC screening preferences will lead to increased adherence. The framework conceptualizes that preference clarification leads to more informed decision-making and, eventually, to better adherence with screening. The specific aims are: 1) To test the effectiveness of a preference-tailored (PT) vs. standard information (SI) intervention for increasing Veterans' CRC screening adherence; 2) To assess the impact of the intervention on informed decision making, knowledge and attitudes toward screening, decisional outcomes, and intention to get screened; and 3) To conduct a cost effectiveness analysis of the PT intervention for increasing CRC screening across the VA.
Methods: A randomized controlled trial of the PT vs. SI decision tool will be conducted in the Ann Arbor and Pittsburgh VA healthcare systems. The intervention was developed by the PI working with the Center for Health Communication Research at the University of Michigan. Eligible patients will be 552 (276 per group) Veterans between 50 and 78 who are due for CRC screening, and who have a primary care visit scheduled within the upcoming 4-6 weeks. Those at high risk (e.g., family or personal history of CRC) will be excluded. Providers will be informed of the study via regular mail and email. In Ann Arbor providers will be given the opportunity to opt-out their participants if they choose to do so. In Pittsburgh providers will be given lists of their participants as they are being considered for the study and will be given the chance to remove any potential participants from the contact list. Potential participants will be mailed an introductory letter. Those who do not opt-out will contacted by telephone. Participants will come to their primary care visit 40 minutes early, at which time they will complete informed consent. The intervention will be delivered via the Internet, and participants will be randomized to the PT or SI arm at the time of log-in. Study measures are consistent with the conceptual framework and based on the Preventive Health Model. Preference information will be collected through the computer program. Secondary outcomes and independent variables will be collected via telephone survey 3 days following the intervention. Adherence to screening will be collected from medical charts at 6 months. CRC screening information in a sub-sample of 80 Ann Arbor Veterans, not in either the PT or SI groups, will also be collected to measure "usual care" (UC). Pittsburgh will use the External Peer Review Program (EPRP) for the collection of clinical performance measures, more specifically CRC screening rates, to serve as an effective substitute for the UC group. Hypotheses related to each aim will be tested using multi-level modeling to control for between-provider effects. The overall hypothesis is that patients in the PT group will have higher rates of adherence to CRC screening at the 6 month follow-up point. Cost effectiveness analysis will determine whether a preference-based screening strategy could be cost effective for the VA healthcare system. The PI will work with the investigative team to disseminate the results through local and national VA websites, publications and presentations.
Status: Active, not recruiting.
- Conditions
- Colorectal Neoplasms
- Being tested
- Standard Information, Preference-tailored Information
- Keywords
- Hospitals, Veterans, Mass Screening/utilization, Patient Preference, Prevention & Control, Epidemiology
- Medical subject headings
- Colorectal Neoplasms, Patient Acceptance of Health Care, Patient Preference
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard InformationBehavioural
A computer based educational overview of CRC and CRC test options will be presented to the subject. The subject will be given a handout with a brief description of each of the screening options and will include the test that they have chosen as their preferred test. The subjects will be asked to take this handout to their upcoming clinic appointment and to discuss the screening options with their care provider.
Preference-tailored InformationBehavioural
A preference elicitation exercise that will generate a list of the three top attributes for the subject and the CRC screening test most consistent with these attributes. Subjects will be provided with a handout to take to their clinic appointment as the Standard Information group does, but with the addition of a listing of their top attributes and the test most consistent with their top attributes.
| Study group | Role | What they receive |
|---|---|---|
| Preference-tailored (PT) intervention | Experimental | Intervention:
Behavioral: Standard Information Behavioral: Preference-tailored Information Receives: Behavioral: Standard Information; Behavioral: Preference-tailored Information |
| Standard information (SI) intervention | Active comparator | Behavioral: Standard Information Receives: Behavioral: Standard Information |
| Usual Care | No intervention | Due to budget and time constraints this group was not powered as a true study arm but was used to assess the impact of our baseline physician information letter and to control for any other interventions of system-wide initiatives that may occur during the study timeframe and impact rated of CRC screening. Data was not collected on every participant in this arm. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Colorectal Cancer (CRC) Screening Rate.
The CRC Screening rate reports percentage of participant adherence with any Colorectal Cancer Screening test within 6 months of Decider Guider intervention. Decider Guider is a tool to help patients make an informed choice about colon cancer testing.
Measured: Within 6 months of Decider Guider intervention.
Secondary outcomes (6)
Number of Elements of Braddock's Informed Decision Making (IDM) Model Discussed With Provider
Outcome measure using 6 items measuring degree of participation in IDM. Scaled and recategorized into Low, Moderate and High level of IDM. The range is from 1 (low level of IDM) to 6 (high level of IDM).
Measured: 3-5 days after Decider Guider intervention
Colorectal Cancer Screening (CRCS) Knowledge and Attitudes.
Outcome measure measuring knowledge of CRCS using 8-item knowledge measure (all true/false questions) developed for study, scaled and categorized into low/moderate/high knowledge, where low = low knowledge and high = high knowledge.
Measured: 3-5 days after Decider Guider intervention.
Decisional Satisfaction
Outcome measures measuring decisional satisfaction using 7-item scale categorized into low, moderate, high.
Decisional satisfaction is a measure that was first developed by Margaret Holmes Rover and colleagues (Med Decis Making. 1996 Jan-Mar;16(1):58-64) to assess the perspective of a patient involved in a medical decision with the decision making process. The measure includes questions related to overall satisfaction, and satisfaction with the amount of information received, involvement in, degree of consistency with values, and time to make the decision. The measure includes 5 questions each on a 5 point scale where higher scores = higher satisfaction. When scaled into one overall measure of decision satisfaction, lower scores = lower satisfaction and higher scores = higher satisfaction.
Measured: 3-5 days after Decider Guider intervention.
Intent to Get Colorectal Cancer Screening.
Outcome measure measuring intent to get CRC screening using 5-item stage of readiness scale. Intent is measured by looking at the highest 2 items (I think I will get screened and I am committed to getting screened).
Measured: 3-5 days after Decider Guider intervention.
Self Efficacy.
Outcome measure measuring self-efficacy using 5-item measure, dichotomized into low vs. high self-efficacy (confidence) in getting screened.
Measured: 3-5 days after Decider Guider intervention.
If Colorectal Cancer Screening Screening (CRCS) Discussed With Provider.
Outcome measure measuring percentage of participants discussing CRCS with provider using single question (yes/no): "did you discuss Colorectal Cancer Screening with your provider?"
Measured: 3-5 days after Decider Guider intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2008 (estimated)
- Study startFeb 2009
- Primary completionMay 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Colorectal NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 466 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Sarah T Hawley, PhD MPH BA, Principal investigator, Ann Arbor VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00810771
- Sponsor's protocol ID
- IIR 06-205
- Acronym
- EPIIC
- Status last verified
- Jun 2015
- First submitted
- 16 Dec 2008
- Last updated
- 2 Jun 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating a Preference-based Intervention for Increasing CRC Screening
- ClinicalTrials.gov ID
- NCT00810771
- Acronym / sponsor ID
- EPIIC / IIR 06-205
- Conditions
- Colorectal Neoplasms
- Keywords
- Hospitals, Veterans, Mass Screening/utilization, Patient Preference, Prevention & Control, Epidemiology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 466 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Feb 2009
- Primary completion
- May 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 18 Dec 2008 (estimated)
- Results
- Posted 2 Jun 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to evaluate whether an educational tool about colorectal cancer (CRC) completed on a computer that helps patients clarify their CRC screening preferences will lead to increased screening rates for CRC compared to standard information delivered via computer.
Detailed description
Background: Colorectal cancer (CRC) is a significant and preventable disease, yet CRC screening remains one of the lowest quality indicators in the VA healthcare system. Moreover, a recent VA directive recommends that CRC screening among Veterans should be based on their preferences, given that there is insufficient evidence to support recommending one test. However the impact of such a preference-based strategy on important outcomes, including screening adherence and cost, is unknown.
Objectives: The broad hypothesis of the proposed study is that helping Veterans clarify their CRC screening preferences will lead to increased adherence. The framework conceptualizes that preference clarification leads to more informed decision-making and, eventually, to better adherence with screening. The specific aims are: 1) To test the effectiveness of a preference-tailored (PT) vs. standard information (SI) intervention for increasing Veterans' CRC screening adherence; 2) To assess the impact of the intervention on informed decision making, knowledge and attitudes toward screening, decisional outcomes, and intention to get screened; and 3) To conduct a cost effectiveness analysis of the PT intervention for increasing CRC screening across the VA.
Methods: A randomized controlled trial of the PT vs. SI decision tool will be conducted in the Ann Arbor and Pittsburgh VA healthcare systems. The intervention was developed by the PI working with the Center for Health Communication Research at the University of Michigan. Eligible patients will be 552 (276 per group) Veterans between 50 and 78 who are due for CRC screening, and who have a primary care visit scheduled within the upcoming 4-6 weeks. Those at high risk (e.g., family or personal history of CRC) will be excluded. Providers will be informed of the study via regular mail and email. In Ann Arbor providers will be given the opportunity to opt-out their participants if they choose to do so. In Pittsburgh providers will be given lists of their participants as they are being considered for the study and will be given the chance to remove any potential participants from the contact list. Potential participants will be mailed an introductory letter. Those who do not opt-out will contacted by telephone. Participants will come to their primary care visit 40 minutes early, at which time they will complete informed consent. The intervention will be delivered via the Internet, and participants will be randomized to the PT or SI arm at the time of log-in. Study measures are consistent with the conceptual framework and based on the Preventive Health Model. Preference information will be collected through the computer program. Secondary outcomes and independent variables will be collected via telephone survey 3 days following the intervention. Adherence to screening will be collected from medical charts at 6 months. CRC screening information in a sub-sample of 80 Ann Arbor Veterans, not in either the PT or SI groups, will also be collected to measure "usual care" (UC). Pittsburgh will use the External Peer Review Program (EPRP) for the collection of clinical performance measures, more specifically CRC screening rates, to serve as an effective substitute for the UC group. Hypotheses related to each aim will be tested using multi-level modeling to control for between-provider effects. The overall hypothesis is that patients in the PT group will have higher rates of adherence to CRC screening at the 6 month follow-up point. Cost effectiveness analysis will determine whether a preference-based screening strategy could be cost effective for the VA healthcare system. The PI will work with the investigative team to disseminate the results through local and national VA websites, publications and presentations.
Status: Active, not recruiting.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Preference-tailored (PT) intervention | Experimental | Behavioral: Standard Information, Behavioral: Preference-tailored InformationIntervention: Behavioral: Standard Information Behavioral: Preference-tailored Information |
| Standard information (SI) intervention | Active comparator | Behavioral: Standard InformationBehavioral: Standard Information |
| Usual Care | No intervention | –Due to budget and time constraints this group was not powered as a true study arm but was used to assess the impact of our baseline physician information letter and to control for any other interventions of system-wide initiatives that may occur during the study timeframe and impact rated of CRC screening. Data was not collected on every participant in this arm. |
Who may qualify
- Ages
- 50 to 78 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Clinic appointment at Ann Arbor or Pittsburgh VA during recruitment period.
- Age 50-78.
- Not up to date with CRC screening according to VA and USPSTF guidelines.
- At average risk for CRC (no history of CRC, adenomatous colon polyps, inflammatory bowel disease, and no family history of CRC).
- Has current address and telephone number listed in medical record.
Key exclusion criteria (12 listed)
- DNR/DNI code status.
- Metastatic cancer.
- Stage D congestive heart failure.
- Severe COPD.
- Coronary artery disease (CAD) and MI within one year or CAD and unstable angina within 6 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard InformationA computer based educational overview of CRC and CRC test options will be presented to the subject. The subject will be given a handout with a brief description of each of the screening options and will include the test that they have chosen as their preferred test. The subjects will be asked to take this handout to their upcoming clinic appointment and to discuss the screening options with their care provider. | Behavioural | Preference-tailored (PT) intervention, Standard information (SI) intervention |
| Preference-tailored InformationA preference elicitation exercise that will generate a list of the three top attributes for the subject and the CRC screening test most consistent with these attributes. Subjects will be provided with a handout to take to their clinic appointment as the Standard Information group does, but with the addition of a listing of their top attributes and the test most consistent with their top attributes. | Behavioural | Preference-tailored (PT) intervention |
Primary outcome
Colorectal Cancer (CRC) Screening Rate.
Time frame: Within 6 months of Decider Guider intervention.
The CRC Screening rate reports percentage of participant adherence with any Colorectal Cancer Screening test within 6 months of Decider Guider intervention. Decider Guider is a tool to help patients make an informed choice about colon cancer testing.
6 secondary outcomes
Number of Elements of Braddock's Informed Decision Making (IDM) Model Discussed With Provider
Time frame: 3-5 days after Decider Guider intervention
Colorectal Cancer Screening (CRCS) Knowledge and Attitudes.
Time frame: 3-5 days after Decider Guider intervention.
Decisional Satisfaction
Time frame: 3-5 days after Decider Guider intervention.
Intent to Get Colorectal Cancer Screening.
Time frame: 3-5 days after Decider Guider intervention.
Self Efficacy.
Time frame: 3-5 days after Decider Guider intervention.
If Colorectal Cancer Screening Screening (CRCS) Discussed With Provider.
Time frame: 3-5 days after Decider Guider intervention.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarah T Hawley, PhD MPH BA principal investigator
Ann Arbor VA Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Information and Preference-tailored Information in people with Colorectal Neoplasms, run by US Department of Veterans Affairs at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Jun 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Colorectal Cancer (CRC) Screening Rate. (time frame: Within 6 months of Decider Guider intervention.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2015.