Colorectal CancerUPQUALNCT00860249
Outreach for Patients That Are Newly Eligible for Colorectal Cancer Screening
A study testing Letter Only and Letter and Educational DVD in people with Colorectal Cancer, 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 preventative screenings for those patients who, based on national quality standards, have become newly eligible for screening measures. We hypothesize that educational outreach may increase completion rates. Read more about this study
- Who is it for?
- Ages 50 to 50 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Letter Only and Letter and Educational DVD
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2009to Dec 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 50 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patient of Northwestern Medical Faculty Foundation General Internal Medicine
- Patient has a scheduled appointment with a GIM physician in the next several weeks
- Patient will be 50 years old at the time of this appointment
- Patient is male or female
Who cannot join
- This is the first time the patient is seen in the NMFF GIM clinic
- There is a prior completion of CRC screening noted in EHR.
- There is a prior order placed for CRC screening in EHR.
- Patient has a history of CRC
- Patient has a diagnosis of ulcerative colitis, inflammatory bowel disease, Crohn's Disease, or documented colectomy.
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 2
The purpose of this study is to evaluate whether patient outreach is effective at increasing compliance with preventative screenings for those patients who, based on national quality standards, have become newly eligible for screening measures. We hypothesize that educational outreach may increase completion rates.
- Conditions
- Colorectal Cancer
- Being tested
- Letter Only, Letter and Educational DVD
- Keywords
- education, preventive service, screening, Colorectal Cancer Screening, Prevention & Control
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Letter OnlyBehavioural
Prior to a scheduled upcoming appointment, participants will get a letter signed by their physician that provides brief information about colorectal cancer (CRC) and notes the importance of CRC screening.
Letter and Educational DVDBehavioural
Participants will get a letter from their physician that provides brief information about colorectal cancer (CRC) and notes the importance of CRC screening. It will be accompanied by an educational DVD about the screening. The participants will receive this prior to a scheduled upcoming appointment with their physician.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | No intervention | Usual Care. Participants in this arm will receive Usual care until outcome assessment is performed at 6 months following randomization. At that time, they will be sent a letter reminding them to obtain the ordered preventative service test, however no further outcomes will be assessed. Thus, during the course of the study, all participants in this arm will have solely received usual care. |
| Behavioral: Letter Only | Experimental | Behavioral: Letter Only Prior to a scheduled upcoming appointment, participants will get a letter signed by their physician that provides brief information about colorectal cancer (CRC) and notes the importance of CRC screening. Receives: Behavioral: Letter Only |
| Behavioral: Letter and Educational DVD | Experimental | Behavioral: Letter and Educational DVD Participants will get a letter from their physician that provides brief information about colorectal cancer (CRC) and notes the importance of CRC screening. It will be accompanied by an educational DVD about the screening. The participants will receive this prior to a scheduled upcoming appointment with their physician. Receives: Behavioral: Letter and Educational DVD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Completion of CRC Screening
What would have been reported as this Outcome Measure is the number of participants who completed screening. We planned to review electronic health records of participants 6 months post randomization to look for either: (1) note in free text MD note documenting receipt of one form of colorectal cancer (CRC) screening during study period or (2)lab results from fecal occult blood test, sigmoidoscopy, or colonoscopy. Screening completion equaled presence of a lab result or physician note in chart. No patient charts were reviewed due to low accrual.
Measured: 6 months from initial contact
Secondary outcomes (1)
The Secondary Outcome for the Study is the Time to Screening Completion.
This Outcome Measure would have reported the length of time, measured in days, that occurred between the date of randomization and the completed screening date. We planned to review the electronic health records of participants 6 months post randomization to look for either: (1)note in free text MD note documenting receipt of one form of CRC screening during study period or (2)lab results from fecal occult blood test, sigmoidoscopy, or colonoscopy. Screening completion equaled presence of a lab result or physician note in chart. No patient charts were reviewed due to low accrual.
Measured: 6 months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2009 (estimated)
- Study startMar 2009
- Primary completionDec 2009
- Study completionDec 2009
Why it stopped: Lack of sufficient participants meeting the eligibility criteria to complete study in proposed and acceptable time frame.
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 CancerStudies 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
- 60 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 Cameron, PhD, Principal investigator, Northwestern University, Department of General Internal Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00860249
- Sponsor's protocol ID
- 1R18HS017163-02
- Acronym
- UPQUAL
- Status last verified
- Nov 2011
- First submitted
- 11 Mar 2009
- Last updated
- 5 Dec 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 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 2
- ClinicalTrials.gov ID
- NCT00860249
- Acronym / sponsor ID
- UPQUAL / 1R18HS017163-02
- Conditions
- Colorectal Cancer
- Keywords
- education, preventive service, screening, Colorectal Cancer Screening, Prevention & Control
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of sufficient participants meeting the eligibility criteria to complete study in proposed and acceptable time frame.
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Study start
- Mar 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 12 Mar 2009 (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 preventative screenings for those patients who, based on national quality standards, have become newly eligible for screening measures. We hypothesize that educational outreach may increase completion rates.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Usual Care | No intervention | –Usual Care. Participants in this arm will receive Usual care until outcome assessment is performed at 6 months following randomization. At that time, they will be sent a letter reminding them to obtain the ordered preventative service test, however no further outcomes will be assessed. Thus, during the course of the study, all participants in this arm will have solely received usual care. |
| Behavioral: Letter Only | Experimental | Behavioral: Letter OnlyBehavioral: Letter Only Prior to a scheduled upcoming appointment, participants will get a letter signed by their physician that provides brief information about colorectal cancer (CRC) and notes the importance of CRC screening. |
| Behavioral: Letter and Educational DVD | Experimental | Behavioral: Letter and Educational DVDBehavioral: Letter and Educational DVD Participants will get a letter from their physician that provides brief information about colorectal cancer (CRC) and notes the importance of CRC screening. It will be accompanied by an educational DVD about the screening. The participants will receive this prior to a scheduled upcoming appointment with their physician. |
Who may qualify
- Ages
- 50 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patient of Northwestern Medical Faculty Foundation General Internal Medicine
- Patient has a scheduled appointment with a GIM physician in the next several weeks
- Patient will be 50 years old at the time of this appointment
- Patient is male or female
Key exclusion criteria (5 listed)
- This is the first time the patient is seen in the NMFF GIM clinic
- There is a prior completion of CRC screening noted in EHR.
- There is a prior order placed for CRC screening in EHR.
- Patient has a history of CRC
- Patient has a diagnosis of ulcerative colitis, inflammatory bowel disease, Crohn's Disease, or documented colectomy.
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 |
|---|---|---|
| Letter OnlyPrior to a scheduled upcoming appointment, participants will get a letter signed by their physician that provides brief information about colorectal cancer (CRC) and notes the importance of CRC screening. | Behavioural | Behavioral: Letter Only |
| Letter and Educational DVDParticipants will get a letter from their physician that provides brief information about colorectal cancer (CRC) and notes the importance of CRC screening. It will be accompanied by an educational DVD about the screening. The participants will receive this prior to a scheduled upcoming appointment with their physician. | Behavioural | Behavioral: Letter and Educational DVD |
Primary outcome
Completion of CRC Screening
Time frame: 6 months from initial contact
What would have been reported as this Outcome Measure is the number of participants who completed screening. We planned to review electronic health records of participants 6 months post randomization to look for either: (1) note in free text MD note documenting receipt of one form of colorectal cancer (CRC) screening during study period or (2)lab results from fecal occult blood test, sigmoidoscopy, or colonoscopy. Screening completion equaled presence of a lab result or physician note in chart. No patient charts were reviewed due to low accrual.
1 secondary outcome
The Secondary Outcome for the Study is the Time to Screening Completion.
Time frame: 6 months after randomization
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2011.
- 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.
Kenzie Cameron, PhD principal investigator
Northwestern University, Department of General Internal Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Letter Only and Letter and Educational DVD in people with Colorectal Cancer, 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 4 inclusion and 5 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: stopped early, as of the sponsor's last update on 5 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?
Completion of CRC Screening (time frame: 6 months from initial contact). 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 5 Dec 2011; AzTrials last refreshed its copy on 8 Nov 2026.