Colorectal Cancer ScreeningUPQUALNCT00793455
Outreach for Patients With Uncompleted Colorectal Cancer Screening Orders
A study testing Educational outreach in people with Colorectal Cancer Screening and Prevention & Control, run by Northwestern University at 1 site in United States.
Trial summary
The purpose of this study is to evaluate whether patient outreach is effective at increasing compliance with preventive screenings ordered by their physician. We hypothesize that educational outreach may increase completion rates. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Colorectal Cancer Screening, Prevention & Control
- What is being tested?
- Educational outreach
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 628 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2008to Nov 2009
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patient's physician has ordered a preventive screening test
- Patient has not completed this test in 3 months
- Patient of Northwestern Medical Faculty Foundation General Internal Medicine Clinic.
Who cannot join
- Patient has been given a more recent order for the same screening test.
- Patient has significant life stress as noted in the Electronic Health Record (EHR)
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern Medical Faculty Foundation General Internal Medicine Clinic
Chicago, Illinois, 60611
About this study
Official title: Using Precision Performance Measurement To Conduct Focused Quality Improvement. Sub-Study 1.
The purpose of this study is to evaluate whether patient outreach is effective at increasing compliance with preventive screenings ordered by their physician. We hypothesize that educational outreach may increase completion rates.
Read the detailed description
We designed an intervention to focus on patients who have received and accepted a referral for colonoscopy, yet have exhibited some barriers to screening as demonstrated by a lack of screening completion. We conducted a randomized controlled trial to assess the effects of a multicomponent intervention (patient reminder, print and multimedia materials) on colorectal screening completion among this target population.
- Conditions
- Colorectal Cancer Screening, Prevention & Control
- Being tested
- Educational outreach
- Keywords
- education, preventive service, screening
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational outreachBehavioural
Participants will get a letter from their physician that explains that their records show the test has not been completed. The letter will be mailed along with an educational brochure and a DVD about colorectal cancer and colorectal cancer screening.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Received Educational Outreach Receives: Behavioral: Educational outreach |
| Usual Care Control Group | No intervention | Participants in this arm will receive normal care until outcome assessment is performed at 6 months following the placement of the order for the preventive service. They will be sent a letter reminding them to obtain the ordered preventive service test. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Colorectal Cancer Screening Completion.
We reviewed electronic health records of participants 3 months post randomization to ascertain outcome. We looked for one or both of the following (1) note in free text MD note documenting receipt of one form of colorectal cancer (CRC) screening during study period (2)lab results from fecal occult blood test, sigmoidoscopy, or colonoscopy.
Participants were categorized as completing CRC screening if there was a lab result or physician note located in chart during study period. If no note or lab result was found in chart, then the participant was categorized as not completing CRC screening.
Measured: 3 months post randomization
Secondary outcomes (1)
Colorectal Cancer Screening Completion
We reviewed electronic health records of participants 6 months post randomization to ascertain outcome. We looked for one or both of the following (1) note in free text MD note documenting receipt of one form of colorectal cancer (CRC) screening during study period (2)lab results from fecal occult blood test, sigmoidoscopy, or colonoscopy.
Participants were categorized as completing CRC screening if there was a lab result or physician note located in chart during study period. If no note or lab result was found in chart, then the participant was categorized as not completing CRC screening.
Measured: 6 months post randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2008 (estimated)
- Study startOct 2008
- Primary completionNov 2009
- Study completionNov 2009
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal Cancer ScreeningStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- 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
- Who is masked
- Participant
- Enrolment
- 628 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Principal investigator, Kenzie Cameron, Northwestern University
- Investigators
- Kenzie A Cameron, PhD, MPH, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00793455
- Sponsor's protocol ID
- 1R18HS017163-01
- Acronym
- UPQUAL
- Status last verified
- Oct 2011
- First submitted
- 17 Nov 2008
- Last updated
- 1 Dec 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Cameron KA, Persell SD, Brown T, Thompson J, Baker DW. Patient outreach to promote colorectal cancer screening among patients with an expired order for colonoscopy: a randomized controlled trial. Arch Intern Med. 2011 Apr 11;171(7):642-6. doi: 10.1001/archinternmed.2010.468. Epub 2010 Dec 13.
PubMed 21149742
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Precision Performance Measurement To Conduct Focused Quality Improvement. Sub-Study 1.
- ClinicalTrials.gov ID
- NCT00793455
- Acronym / sponsor ID
- UPQUAL / 1R18HS017163-01
- Conditions
- Colorectal Cancer Screening, Prevention & Control
- Keywords
- education, preventive service, screening
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 628 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Study start
- Oct 2008
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 19 Nov 2008 (estimated)
- Results
- Posted 1 Dec 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate whether patient outreach is effective at increasing compliance with preventive screenings ordered by their physician. We hypothesize that educational outreach may increase completion rates.
Detailed description
We designed an intervention to focus on patients who have received and accepted a referral for colonoscopy, yet have exhibited some barriers to screening as demonstrated by a lack of screening completion. We conducted a randomized controlled trial to assess the effects of a multicomponent intervention (patient reminder, print and multimedia materials) on colorectal screening completion among this target population.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Educational outreachReceived Educational Outreach |
| Usual Care Control Group | No intervention | –Participants in this arm will receive normal care until outcome assessment is performed at 6 months following the placement of the order for the preventive service. They will be sent a letter reminding them to obtain the ordered preventive service test. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patient's physician has ordered a preventive screening test
- Patient has not completed this test in 3 months
- Patient of Northwestern Medical Faculty Foundation General Internal Medicine Clinic.
Key exclusion criteria (2 listed)
- Patient has been given a more recent order for the same screening test.
- Patient has significant life stress as noted in the Electronic Health Record (EHR)
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 |
|---|---|---|
| Educational outreachParticipants will get a letter from their physician that explains that their records show the test has not been completed. The letter will be mailed along with an educational brochure and a DVD about colorectal cancer and colorectal cancer screening. | Behavioural | Intervention Group |
Primary outcome
Colorectal Cancer Screening Completion.
Time frame: 3 months post randomization
We reviewed electronic health records of participants 3 months post randomization to ascertain outcome. We looked for one or both of the following (1) note in free text MD note documenting receipt of one form of colorectal cancer (CRC) screening during study period (2)lab results from fecal occult blood test, sigmoidoscopy, or colonoscopy. Participants were categorized as completing CRC screening if there was a lab result or physician note located in chart during study period. If no note or lab result was found in chart, then the participant was categorized as not completing CRC screening.
1 secondary outcome
Colorectal Cancer Screening Completion
Time frame: 6 months post randomization
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 21149742Cameron KA, Persell SD, Brown T, Thompson J, Baker DW. Patient outreach to promote colorectal cancer screening among patients with an expired order for colonoscopy: a randomized controlled trial. Arch Intern Med. 2011 Apr 11;171(7):642-6. doi: 10.1001/archinternmed.2010.468. Epub 2010 Dec 13.
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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.
Kenzie A Cameron, PhD, MPH principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational outreach in people with Colorectal Cancer Screening and Prevention & Control, run by Northwestern University at 1 site 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 3 inclusion and 2 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 1 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 1 Dec 2011). 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 Screening Completion. (time frame: 3 months post randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00793455, which also lists 1 linked publication.
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 1 Dec 2011.