Clinical trial NCT01320826: The Alberta Primary Care Endoscopy (APC-Endo) Study
Official title: Prospective Study of the Quality of Colonoscopies Performed by Primary Care Endoscopists in Alberta, Canada
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Screening Test
Endoscopy
Colon Disease
Keywords: colonoscopy
primary care physicians
quality assurance
Lead sponsor: University of Alberta
Sponsor class: OTHER
Collaborators: name: Alberta Ministry of Health - Alberta Rural Physician Action Plan
First posted: 2011-03-23
Enrollment: 577
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Percentage of Successful Cecal Intubations (Crude)
timeFrame: At time of colonoscopy (DAY 1 of study)
measure: Percentage of Successful Cecal Intubations (Adjusted)
timeFrame: At time of colonoscopy (DAY 1 of study)
measure: Adenoma Detection Ratio
timeFrame: When pathology from colonoscopy available (on average 2-3 weeks after procedure)
measure: Percentage of Males 50 Years and Older Undergoing First Time Colonoscopy With an Adenoma
timeFrame: When pathology from colonoscopy available (on average 2-3 weeks after procedure)
measure: Percentage of Females 50 Years and Older Undergoing First Time Colonoscopy With an Adenoma
timeFrame: [When pathology from colonoscopy available (on average 2-3 weeks after procedure)]
Secondary outcomes:
measure: Colonoscopy Complications: Bleeding, Perforation, Cardiopulmonary Complications Secondary to Conscious Sedation, and Death.
timeFrame: Within four (4) weeks of colonoscopy
measure: Colonoscopy Withdraw Time in Cases Where no Lesions Found
timeFrame: At time of colonoscopy (DAY 1 of study)
measure: Patient Comfort During Colonoscopy
timeFrame: At time of colonoscopy (DAY 1 of study)
measure: Patient Satisfaction With Endoscopy Wait Time
timeFrame: At patient satisfaction phone survey (on average 4 weeks after colonoscopy)
measure: Patient Satisfaction With Hospital Experience for Colonoscopy
timeFrame: At patient satisfaction phone survey (on average 4 weeks after colonoscopy)
measure: Colonoscopy Procedure Time
timeFrame: At time of colonoscopy (DAY 1 of study)
measure: Percentage of Patients Referred to a Specialist.
timeFrame: Within four (4) weeks of colonoscopy
Other outcomes:
Locations:
city: Barrhead
country: Canada
facility: Barrhead Healthcare Centre
state: Alberta
city: Bonnyville
country: Canada
facility: Bonnyville Healthcare Centre
state: Alberta
city: Camrose
country: Canada
facility: St. Mary's Hospital
state: Alberta
city: Daysland
country: Canada
facility: Daysland Health Centre
state: Alberta
city: Grande Prairie
country: Canada
facility: Queen Elizabeth 2 Hospital
state: Alberta
city: Lac La Biche
country: Canada
facility: William J. Cadzow Health Centre
state: Alberta
city: Mclennan
country: Canada
facility: Sacred Heart Hospital
state: Alberta
city: Peace River
country: Canada
facility: Peace River Community Health Centre
state: Alberta
city: Pincher Creek
country: Canada
facility: Pincher Creek Hospital
state: Alberta
city: Ponoka
country: Canada
facility: Ponoka Hospital and Care Centre
state: Alberta
city: St. Albert
country: Canada
facility: Sturgeon Community Hospital
state: Alberta
city: Taber
country: Canada
facility: Taber Hospital
state: Alberta
city: Whitecourt
country: Canada
facility: Whitecourt Healthcare Centre
state: Alberta
Study officials:
affiliation: University of Alberta
name: Michael R Kolber, MD, CCFP
role: STUDY_DIRECTOR
affiliation: University of Alberta
name: Brian H Rowe, MD, CCFP(EM)
role: PRINCIPAL_INVESTIGATOR
References: