The Alberta Primary Care Endoscopy (APC-Endo) Study

Endoscopy Clinical Trial

— APC-Endo  

Official title:

Prospective Study of the Quality of Colonoscopies Performed by Primary Care Endoscopists in Alberta, Canada

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01320826
• Other study ID #: 2011-APCEndo-MK
• Status: Completed
• Phase: N/A
• First received: March 3, 2011
• Last updated: August 14, 2012
• Start date: March 2010
• Est. completion date: October 2010

Study information

• Verified date: August 2012
• Source: University of Alberta
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Observational

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 577
• Est. completion date: October 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Colon Disease
• Colonic Diseases
• Endoscopy
• Screening Test

Intervention

Procedure:
• colonoscopy
Data pertaining to all colonoscopies performed by a APC-Endo study physician over a two month period will be collected.

Locations

Country	Name	City	State
Canada	Barrhead Healthcare Centre	Barrhead	Alberta
Canada	Bonnyville Healthcare Centre	Bonnyville	Alberta
Canada	St. Mary's Hospital	Camrose	Alberta
Canada	Daysland Health Centre	Daysland	Alberta
Canada	Queen Elizabeth 2 Hospital	Grande Prairie	Alberta
Canada	William J. Cadzow Health Centre	Lac La Biche	Alberta
Canada	Sacred Heart Hospital	Mclennan	Alberta
Canada	Peace River Community Health Centre	Peace River	Alberta
Canada	Pincher Creek Hospital	Pincher Creek	Alberta
Canada	Ponoka Hospital and Care Centre	Ponoka	Alberta
Canada	Sturgeon Community Hospital	St. Albert	Alberta
Canada	Taber Hospital	Taber	Alberta
Canada	Whitecourt Healthcare Centre	Whitecourt	Alberta

Sponsors (2)

Lead Sponsor	Collaborator
University of Alberta	Alberta Ministry of Health - Alberta Rural Physician Action Plan

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	At time of colonoscopy (DAY 1 of study)	No
Primary	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)	At time of colonoscopy (DAY 1 of study)	No
Primary	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.	When pathology from colonoscopy available (on average 2-3 weeks after procedure)	No
Primary	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.	When pathology from colonoscopy available (on average 2-3 weeks after procedure)	No
Primary	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.	[When pathology from colonoscopy available (on average 2-3 weeks after procedure)]	No
Secondary	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.	Within four (4) weeks of colonoscopy	Yes
Secondary	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.	At time of colonoscopy (DAY 1 of study)	No
Secondary	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.	At time of colonoscopy (DAY 1 of study)	No
Secondary	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	At patient satisfaction phone survey (on average 4 weeks after colonoscopy)	No
Secondary	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	At patient satisfaction phone survey (on average 4 weeks after colonoscopy)	No
Secondary	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.	At time of colonoscopy (DAY 1 of study)	No
Secondary	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).	Within four (4) weeks of colonoscopy	No