Screening TestAPC-EndoNCT01320826
The Alberta Primary Care Endoscopy (APC-Endo) Study
An observational study of Screening Test and Endoscopy, run by University of Alberta at 13 sites in Canada.
Trial summary
It is hypothesized that primary care colonoscopists are able to achieve benchmarks in colonoscopy quality including cecal intubation and adenoma detection rates and serious adverse event rates. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Screening Test, Endoscopy, Colon Disease
- What is being tested?
- colonoscopy
- Type of treatment
- Surgery or procedure
- How many people
- 577 participants
- Where
- 13 sitesCanada
- Study dates
- Mar 2010to Oct 2010
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Physician colonoscopists: All Albertan family physicians and general internists who perform colonoscopies will be invited to voluntarily participate in anonymized data collection pertaining to the quality of colonoscopies they perform over a two month period. All patients having a colonoscopy done by an APC-Endo physician endoscopist during the study period will be approached at the time of their endoscopy to consent to the post procedure telephone survey.
Who may be able to join
- All patients having a colonoscopy done by an APC-Endo physician endoscopist during the study period will be approached at the time of their endoscopy to consent to the post procedure telephone.
Who cannot join
- Patients under the age of 18 years old
- Patients who will be unable to be contacted for the post procedure telephone survey. (e.g., moving out of the country in the following month)
- Patients who are unable to understand or speak basic English
- Patients who are cognitively impaired such that they were not able to complete the initial consent for their colonoscopy
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
Canada13 sites
Barrhead Healthcare Centre
Barrhead, Alberta, T7N 1M1
Bonnyville Healthcare Centre
Bonnyville, Alberta, T9N 1M3
St. Mary's Hospital
Camrose, Alberta, T4V 1Y5
Daysland Health Centre
Daysland, Alberta, T08 1A0
Queen Elizabeth 2 Hospital
Grande Prairie, Alberta, T8V 0N5
William J. Cadzow Health Centre
Lac La Biche, Alberta, T0A 2C0
Sacred Heart Hospital
McLennan, Alberta, T0H 2L0
Peace River Community Health Centre
Peace River, Alberta, T8S 1T6
Pincher Creek Hospital
Pincher Creek, Alberta, T0K 1W0
Ponoka Hospital and Care Centre
Ponoka, Alberta, T4J 1P1
Sturgeon Community Hospital
St. Albert, Alberta, T8N 6C4
Taber Hospital
Taber, Alberta, T1G 1N9
Whitecourt Healthcare Centre
Whitecourt, Alberta, T7S 1M8
About this study
Official title: Prospective Study of the Quality of Colonoscopies Performed by Primary Care Endoscopists in Alberta, Canada
It is hypothesized that primary care colonoscopists are able to achieve benchmarks in colonoscopy quality including cecal intubation and adenoma detection rates and serious adverse event rates.
This prospective study is the first in depth analysis of the quality of colonoscopic procedures performed by primary care physicians at a provincial level in Canada.
In addition, the APC Endo study is the first to directly examine both the quality of colonoscopy and patient satisfaction in the same study.
Read the detailed description
Discrepant data exists about the quality of colonoscopies performed by family physicians and general internists. Currently in Canada, gastroenterologists and general surgeons perform 97% of the colonoscopies, but excessive wait times highlight a shortage of colonoscopists in Canada. This shortage will invariably worsen as our population ages and more Canadians become screened for colorectal cancer.
One method of improving this relative shortage of colonoscopists is through training primary care physicians in GI medicine and endoscopy. In order these physicians to be a legitimate option in the provision of colonoscopies; however, it must be shown that, as a group, they are able to meet benchmarks in colonoscopy competency.
This multi-centre observational study will be the first study to prospectively analyze colonoscopic examinations performed by primary care physicians at a provincial level. Using primarily cecal intubation rates and adenoma detection rates, along with other quality parameters, this study will compare the results of Alberta primary care physicians to standard benchmarks in colonoscopy competency.
Data will be collected using case report forms completed at the time of the colonoscopy, reviewing the patients' colonoscopy pathology results and a post procedure telephone survey to examine patient satisfaction rates.
If this study demonstrates that quality benchmarks are indeed met, then future training of primary care physicians in gastrointestinal medicine and endoscopy would be encouraged to help address current and future colonoscopist shortages.
- Conditions
- Screening Test, Endoscopy, Colon Disease
- Being tested
- colonoscopy
- Keywords
- colonoscopy, primary care physicians, quality assurance
- Medical subject headings
- Colonic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
colonoscopyProcedure or surgery
Data pertaining to all colonoscopies performed by a APC-Endo study physician over a two month period will be collected.
| Study group | Role | What they receive |
|---|---|---|
| Physician colonoscopists | All primary care physicians (family physicians and general internists) who perform colonoscopies were approached to voluntarily participate in the APC-Endo study.
All patients having a colonoscopy done by an APC-Endo study physician endoscopist were approached at the time of their endoscopy to consent to the post procedure telephone survey. Receives: Procedure: colonoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Successful Cecal Intubations (Crude)
The percentage of successful cecal intubations (crude) = (total # of colonoscopies performed where cecal intubation was achieved / total # of colonoscopies attempted) x 100
Measured: At time of colonoscopy (DAY 1 of study)
Percentage of Successful Cecal Intubations (Adjusted)
The percentage of successful cecal intubations (adjusted) = total number of colonoscopies performed where cecal intubation was achieved / (total number of colonoscopies attempted -incomplete colonoscopies due to poor bowel preparation, colonic stricture, equipment failure or severe endoscopic colitis)
Measured: At time of colonoscopy (DAY 1 of study)
Adenoma Detection Ratio
The adenoma detection ratio is the number of pathologically verified adenomas per number of colonoscopies performed. Adenoma detection ratio = total number of pathologically confirmed adenomas / number of colonoscopies attempted.
Measured: When pathology from colonoscopy available (on average 2-3 weeks after procedure)
Percentage of Males 50 Years and Older Undergoing First Time Colonoscopy With an Adenoma
Percentage of patients with an adenoma = (number of patients who had at least one adenoma detected on colonoscopy / total number of colonoscopies attempted) x 100.
For this specific outcome: we explored this outcome for males 50 years and older undergoing first time colonoscopy.
Measured: When pathology from colonoscopy available (on average 2-3 weeks after procedure)
Percentage of Females 50 Years and Older Undergoing First Time Colonoscopy With an Adenoma
Percentage of patients with an adenoma = (number of patients who had at least one adenoma detected on colonoscopy / total number of colonoscopies attempted) x 100.
For this specific outcome: we explored this outcome for females 50 years and older undergoing first time colonoscopy.
Measured: [When pathology from colonoscopy available (on average 2-3 weeks after procedure)]
Secondary outcomes (7)
Colonoscopy Complications: Bleeding, Perforation, Cardiopulmonary Complications Secondary to Conscious Sedation, and Death.
Potential serious complications of colonoscopy include bleeding, perforation, cardiopulmonary complications secondary to conscious sedation and death.
Potential serious complications will be determined from the case report form (physician reported) and at patient satisfaction phone survey (on average four weeks after colonoscopy).
All potential serious complications of colonoscopy will be externally adjudicated.
Measured: Within four (4) weeks of colonoscopy
Colonoscopy Withdraw Time in Cases Where no Lesions Found
Withdrawal time will be defined as the time from leaving the cecum until the colonoscope exits the anus. This will be calculated for cases in which no lesions were found.
Measured: At time of colonoscopy (DAY 1 of study)
Patient Comfort During Colonoscopy
To determine the patients' comfort level during the colonoscopy, a five-item question used by the Joint Advisory Group on Gastrointestinal Endoscopy in the United Kingdom will be used.
Patient discomfort on the 5 point scale:
0 is no discomfort;
- is one or two episodes of discomfort, well tolerated;
- is more than two episodes of discomfort adequately tolerated;
- is significant discomfort experienced several times during the procedure;
- is extreme discomfort experienced frequency throughout the procedure.
Minimum value = 0, maximum value = 4 with 4 being worse.
Measured: At time of colonoscopy (DAY 1 of study)
Patient Satisfaction With Endoscopy Wait Time
Patient satisfaction with endoscopy wait time will be recorded using a 7 point Likert scale at the time of the patient phone survey. 7 is extremely satisfied and 1 is extremely dissatisfied
minimum score = 1 maximum score = 7
Measured: At patient satisfaction phone survey (on average 4 weeks after colonoscopy)
Patient Satisfaction With Hospital Experience for Colonoscopy
Patient satisfaction with their hospital experience during their colonoscopy will be recorded by using a 7 point Likert scale at the time of the patient satisfaction phone survey.
7 = extremely satisfied
1 = extremely dissatisfied
Minimum score = 1 Maximum score = 7
Measured: At patient satisfaction phone survey (on average 4 weeks after colonoscopy)
Colonoscopy Procedure Time
Colonoscopic procedural time will be defined as the time from the first insertion of the colonoscope until it is removed from the anus.
Measured: At time of colonoscopy (DAY 1 of study)
Percentage of Patients Referred to a Specialist.
The percentage of patients who are anticipated to be referred to specialists, for the gastrointestinal complaint for which the colonoscopy was performed will be determined and the reason for referral will be tabulated. The referral percentage will be determined both from the time of colonoscopy (physician reported) and from the patient satisfaction phone survey (patient reported).
Measured: Within four (4) weeks of colonoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2011 (estimated)
- Study startMar 2010
- Primary completionJun 2010
- Study completionOct 2010
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 Screening TestStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 577 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- Alberta Ministry of Health - Alberta Rural Physician Action Plan
- Responsible party
- Principal investigator, Brian Rowe, University of Alberta
- Investigators
- Michael R Kolber, MD, CCFP, Study director, University of AlbertaBrian H Rowe, MD, CCFP(EM), Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01320826
- Sponsor's protocol ID
- 2011-APCEndo-MK
- Acronym
- APC-Endo
- Status last verified
- Aug 2012
- First submitted
- 3 Mar 2011
- Last updated
- 15 Aug 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study of the Quality of Colonoscopies Performed by Primary Care Endoscopists in Alberta, Canada
- ClinicalTrials.gov ID
- NCT01320826
- Acronym / sponsor ID
- APC-Endo / 2011-APCEndo-MK
- Conditions
- Screening Test, Endoscopy, Colon Disease
- Keywords
- colonoscopy, primary care physicians, quality assurance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 577 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Collaborators
- Alberta Ministry of Health - Alberta Rural Physician Action Plan
- Study start
- Mar 2010
- Primary completion
- Jun 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 23 Mar 2011 (estimated)
- Results
- Posted 15 Aug 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
It is hypothesized that primary care colonoscopists are able to achieve benchmarks in colonoscopy quality including cecal intubation and adenoma detection rates and serious adverse event rates.
This prospective study is the first in depth analysis of the quality of colonoscopic procedures performed by primary care physicians at a provincial level in Canada.
In addition, the APC Endo study is the first to directly examine both the quality of colonoscopy and patient satisfaction in the same study.
Detailed description
Discrepant data exists about the quality of colonoscopies performed by family physicians and general internists. Currently in Canada, gastroenterologists and general surgeons perform 97% of the colonoscopies, but excessive wait times highlight a shortage of colonoscopists in Canada. This shortage will invariably worsen as our population ages and more Canadians become screened for colorectal cancer.
One method of improving this relative shortage of colonoscopists is through training primary care physicians in GI medicine and endoscopy. In order these physicians to be a legitimate option in the provision of colonoscopies; however, it must be shown that, as a group, they are able to meet benchmarks in colonoscopy competency.
This multi-centre observational study will be the first study to prospectively analyze colonoscopic examinations performed by primary care physicians at a provincial level. Using primarily cecal intubation rates and adenoma detection rates, along with other quality parameters, this study will compare the results of Alberta primary care physicians to standard benchmarks in colonoscopy competency.
Data will be collected using case report forms completed at the time of the colonoscopy, reviewing the patients' colonoscopy pathology results and a post procedure telephone survey to examine patient satisfaction rates.
If this study demonstrates that quality benchmarks are indeed met, then future training of primary care physicians in gastrointestinal medicine and endoscopy would be encouraged to help address current and future colonoscopist shortages.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Physician colonoscopists | – | Procedure: colonoscopyAll primary care physicians (family physicians and general internists) who perform colonoscopies were approached to voluntarily participate in the APC-Endo study. All patients having a colonoscopy done by an APC-Endo study physician endoscopist were approached at the time of their endoscopy to consent to the post procedure telephone survey. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Physician colonoscopists: All Albertan family physicians and general internists who perform colonoscopies will be invited to voluntarily participate in anonymized data collection pertaining to the quality of colonoscopies they perform over a two month period. All patients having a colonoscopy done by an APC-Endo physician endoscopist during the study period will be approached at the time of their endoscopy to consent to the post procedure telephone survey.
Key inclusion criteria (1 listed)
- All patients having a colonoscopy done by an APC-Endo physician endoscopist during the study period will be approached at the time of their endoscopy to consent to the post procedure telephone.
Key exclusion criteria (4 listed)
- Patients under the age of 18 years old
- Patients who will be unable to be contacted for the post procedure telephone survey. (e.g., moving out of the country in the following month)
- Patients who are unable to understand or speak basic English
- Patients who are cognitively impaired such that they were not able to complete the initial consent for their colonoscopy
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 |
|---|---|---|
| colonoscopyData pertaining to all colonoscopies performed by a APC-Endo study physician over a two month period will be collected. | Procedure or surgery | Physician colonoscopists |
Primary outcome
Percentage of Successful Cecal Intubations (Crude)
Time frame: At time of colonoscopy (DAY 1 of study)
The percentage of successful cecal intubations (crude) = (total # of colonoscopies performed where cecal intubation was achieved / total # of colonoscopies attempted) x 100
Percentage of Successful Cecal Intubations (Adjusted)
Time frame: At time of colonoscopy (DAY 1 of study)
The percentage of successful cecal intubations (adjusted) = total number of colonoscopies performed where cecal intubation was achieved / (total number of colonoscopies attempted -incomplete colonoscopies due to poor bowel preparation, colonic stricture, equipment failure or severe endoscopic colitis)
Adenoma Detection Ratio
Time frame: When pathology from colonoscopy available (on average 2-3 weeks after procedure)
The adenoma detection ratio is the number of pathologically verified adenomas per number of colonoscopies performed. Adenoma detection ratio = total number of pathologically confirmed adenomas / number of colonoscopies attempted.
Percentage of Males 50 Years and Older Undergoing First Time Colonoscopy With an Adenoma
Time frame: When pathology from colonoscopy available (on average 2-3 weeks after procedure)
Percentage of patients with an adenoma = (number of patients who had at least one adenoma detected on colonoscopy / total number of colonoscopies attempted) x 100. For this specific outcome: we explored this outcome for males 50 years and older undergoing first time colonoscopy.
Percentage of Females 50 Years and Older Undergoing First Time Colonoscopy With an Adenoma
Time frame: [When pathology from colonoscopy available (on average 2-3 weeks after procedure)]
Percentage of patients with an adenoma = (number of patients who had at least one adenoma detected on colonoscopy / total number of colonoscopies attempted) x 100. For this specific outcome: we explored this outcome for females 50 years and older undergoing first time colonoscopy.
7 secondary outcomes
Colonoscopy Complications: Bleeding, Perforation, Cardiopulmonary Complications Secondary to Conscious Sedation, and Death.
Time frame: Within four (4) weeks of colonoscopy
Colonoscopy Withdraw Time in Cases Where no Lesions Found
Time frame: At time of colonoscopy (DAY 1 of study)
Patient Comfort During Colonoscopy
Time frame: At time of colonoscopy (DAY 1 of study)
Patient Satisfaction With Endoscopy Wait Time
Time frame: At patient satisfaction phone survey (on average 4 weeks after colonoscopy)
Patient Satisfaction With Hospital Experience for Colonoscopy
Time frame: At patient satisfaction phone survey (on average 4 weeks after colonoscopy)
Colonoscopy Procedure Time
Time frame: At time of colonoscopy (DAY 1 of study)
Percentage of Patients Referred to a Specialist.
Time frame: Within four (4) weeks of colonoscopy
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2012.
- 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.
Michael R Kolber, MD, CCFP study director
University of Alberta
Brian H Rowe, MD, CCFP(EM) principal investigator
University of Alberta
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Screening Test and Endoscopy, run by University of Alberta at 13 sites in Canada.
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 1 inclusion and 4 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 15 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Canada. 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 15 Aug 2012). 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?
Percentage of Successful Cecal Intubations (Crude) (time frame: At time of colonoscopy (DAY 1 of study)). The study lists 5 primary outcomes in all. 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 15 Aug 2012.