The Alberta Primary Care Endoscopy (APC-Endo) Study

NCT01320826 | Completed Results

• 1 other identifier: 2011-APCEndo-MK
• Study Type: observational
• Target: 577
• Locations: 1 country
• Sites: 13

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.

Conditions

Screening Test; Endoscopy; Colon Disease

Keywords

colonoscopy; primary care physicians; quality assurance

Outcome Measures

Primary Outcomes (5)

• 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)

• 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)

• 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)

• 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)

• 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)]

Secondary Outcomes (7)

• Colonoscopy Complications: Bleeding, Perforation, Cardiopulmonary Complications Secondary to Conscious Sedation, and Death.

  Within four (4) weeks of colonoscopy

• Colonoscopy Withdraw Time in Cases Where no Lesions Found

  At time of colonoscopy (DAY 1 of study)

• Patient Comfort During Colonoscopy

  At time of colonoscopy (DAY 1 of study)

• Patient Satisfaction With Endoscopy Wait Time

  At patient satisfaction phone survey (on average 4 weeks after colonoscopy)

• Patient Satisfaction With Hospital Experience for Colonoscopy

  At patient satisfaction phone survey (on average 4 weeks after colonoscopy)

Study Arms (1)

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.

Procedure: colonoscopy

Interventions

colonoscopy PROCEDURE

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

Physician colonoscopists

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alberta: lead
• Alberta Ministry of Health - Alberta Rural Physician Action Plan: collaborator

Study Sites (13)

Barrhead Healthcare Centre

Barrhead, Alberta, T7N 1M1, Canada

Location

Bonnyville Healthcare Centre

Bonnyville, Alberta, T9N 1M3, Canada

Location

St. Mary's Hospital

Camrose, Alberta, T4V 1Y5, Canada

Location

Daysland Health Centre

Daysland, Alberta, T08 1A0, Canada

Location

Queen Elizabeth 2 Hospital

Grande Prairie, Alberta, T8V 0N5, Canada

Location

William J. Cadzow Health Centre

Lac La Biche, Alberta, T0A 2C0, Canada

Location

Sacred Heart Hospital

McLennan, Alberta, T0H 2L0, Canada

Location

Peace River Community Health Centre

Peace River, Alberta, T8S 1T6, Canada

Location

Pincher Creek Hospital

Pincher Creek, Alberta, T0K 1W0, Canada

Location

Ponoka Hospital and Care Centre

Ponoka, Alberta, T4J 1P1, Canada

Location

Sturgeon Community Hospital

St. Albert, Alberta, T8N 6C4, Canada

Location

Taber Hospital

Taber, Alberta, T1G 1N9, Canada

Location

Whitecourt Healthcare Centre

Whitecourt, Alberta, T7S 1M8, Canada

Location

MeSH Terms

Conditions

Colonic Diseases

Interventions

Colonoscopy

Condition Hierarchy (Ancestors)

Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Results Point of Contact

• Title: Dr. Michael Kolber
• Organization: University of Alberta

mkolber@ualberta.ca

(780) 616-8411

Study Officials

• Michael R Kolber, MD, CCFP

  University of Alberta

  STUDY DIRECTOR

• Brian H Rowe, MD, CCFP(EM)

  University of Alberta

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Dean (Clinical Research), Faculty of Medicine and Dentistry Canada Research Chair in Emergency Airway Diseases Professor and Research Director Department of Emergency Medicine, University of Alberta

Study Record Dates

• First Submitted: March 3, 2011
• First Posted: March 23, 2011
• Study Start: March 1, 2010
• Primary Completion: June 1, 2010
• Study Completion: October 1, 2010
• Last Updated: August 15, 2012
• Results First Posted: August 15, 2012

Record last verified: 2012-08

Locations

CA (13)