The Alberta Primary Care Endoscopy (APC-Endo) Study

This study has been completed.
Sponsor:
Collaborator:
Alberta Ministry of Health - Alberta Rural Physician Action Plan
Information provided by (Responsible Party):
Brian Rowe, University of Alberta
ClinicalTrials.gov Identifier:
NCT01320826
First received: March 3, 2011
Last updated: August 14, 2012
Last verified: August 2012
  Purpose

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.


Condition Intervention
Screening Test
Endoscopy
Colon Disease
Procedure: colonoscopy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Study of the Quality of Colonoscopies Performed by Primary Care Endoscopists in Alberta, Canada

Resource links provided by NLM:


Further study details as provided by University of Alberta:

Primary Outcome Measures:
  • Percentage of Successful Cecal Intubations (Crude) [ Time Frame: At time of colonoscopy (DAY 1 of study) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]

    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)] ] [ Designated as safety issue: No ]

    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.



Secondary Outcome Measures:
  • Colonoscopy Complications: Bleeding, Perforation, Cardiopulmonary Complications Secondary to Conscious Sedation, and Death. [ Time Frame: Within four (4) weeks of colonoscopy ] [ Designated as safety issue: Yes ]

    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.


  • Colonoscopy Withdraw Time in Cases Where no Lesions Found [ Time Frame: At time of colonoscopy (DAY 1 of study) ] [ Designated as safety issue: No ]
    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.

  • Patient Comfort During Colonoscopy [ Time Frame: At time of colonoscopy (DAY 1 of study) ] [ Designated as safety issue: No ]

    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;

    1. is one or two episodes of discomfort, well tolerated;
    2. is more than two episodes of discomfort adequately tolerated;
    3. is significant discomfort experienced several times during the procedure;
    4. is extreme discomfort experienced frequency throughout the procedure.

    Minimum value = 0, maximum value = 4 with 4 being worse.


  • Patient Satisfaction With Endoscopy Wait Time [ Time Frame: At patient satisfaction phone survey (on average 4 weeks after colonoscopy) ] [ Designated as safety issue: No ]

    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


  • Patient Satisfaction With Hospital Experience for Colonoscopy [ Time Frame: At patient satisfaction phone survey (on average 4 weeks after colonoscopy) ] [ Designated as safety issue: No ]

    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


  • Colonoscopy Procedure Time [ Time Frame: At time of colonoscopy (DAY 1 of study) ] [ Designated as safety issue: No ]
    Colonoscopic procedural time will be defined as the time from the first insertion of the colonoscope until it is removed from the anus.

  • Percentage of Patients Referred to a Specialist. [ Time Frame: Within four (4) weeks of colonoscopy ] [ Designated as safety issue: No ]
    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).


Enrollment: 577
Study Start Date: March 2010
Study Completion Date: October 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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
Data pertaining to all colonoscopies performed by a APC-Endo study physician over a two month period will be collected.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01320826

Locations
Canada, Alberta
Barrhead Healthcare Centre
Barrhead, Alberta, Canada, T7N 1M1
Bonnyville Healthcare Centre
Bonnyville, Alberta, Canada, T9N 1M3
St. Mary's Hospital
Camrose, Alberta, Canada, T4V 1Y5
Daysland Health Centre
Daysland, Alberta, Canada, T08 1A0
Queen Elizabeth 2 Hospital
Grande Prairie, Alberta, Canada, T8V 0N5
William J. Cadzow Health Centre
Lac La Biche, Alberta, Canada, T0A 2C0
Sacred Heart Hospital
Mclennan, Alberta, Canada, T0H 2L0
Peace River Community Health Centre
Peace River, Alberta, Canada, T8S 1T6
Pincher Creek Hospital
Pincher Creek, Alberta, Canada, T0K 1W0
Ponoka Hospital and Care Centre
Ponoka, Alberta, Canada, T4J 1P1
Sturgeon Community Hospital
St. Albert, Alberta, Canada, T8N 6C4
Taber Hospital
Taber, Alberta, Canada, T1G 1N9
Whitecourt Healthcare Centre
Whitecourt, Alberta, Canada, T7S 1M8
Sponsors and Collaborators
University of Alberta
Alberta Ministry of Health - Alberta Rural Physician Action Plan
Investigators
Study Director: Michael R Kolber, MD, CCFP University of Alberta
Principal Investigator: Brian H Rowe, MD, CCFP(EM) University of Alberta
  More Information

No publications provided

Responsible Party: Brian Rowe, 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, University of Alberta
ClinicalTrials.gov Identifier: NCT01320826     History of Changes
Other Study ID Numbers: 2011-APCEndo-MK
Study First Received: March 3, 2011
Results First Received: March 17, 2012
Last Updated: August 14, 2012
Health Authority: Canada: Ethics Review Committee

Keywords provided by University of Alberta:
colonoscopy
primary care physicians
quality assurance

Additional relevant MeSH terms:
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on July 22, 2014