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Completed

NCT Number: NCT01320826

The Alberta Primary Care Endoscopy (APC-Endo) Study

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.

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Key information

Conditions

Screening Test Colon Disease Colonic Diseases Digestive System Diseases Endoscopy Gastrointestinal Diseases Intestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Barrhead Healthcare Centre, Barrhead, Alberta, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

colonoscopy

Procedure

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

Primary outcomes

  1. 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

  2. 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)

  3. 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.

  4. 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.

  5. 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.

Secondary outcomes

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

    Time frame: Within four (4) weeks of colonoscopy

    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.

  2. Colonoscopy Withdraw Time in Cases Where no Lesions Found

    Time frame: At time of colonoscopy (DAY 1 of study)

    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.

  3. Patient Comfort During Colonoscopy

    Time frame: At time of colonoscopy (DAY 1 of study)

    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.

  4. Patient Satisfaction With Endoscopy Wait Time

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

    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

  5. Patient Satisfaction With Hospital Experience for Colonoscopy

    Time frame: At patient satisfaction phone survey (on average 4 weeks after 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

  6. Colonoscopy Procedure Time

    Time frame: At time of colonoscopy (DAY 1 of study)

    Colonoscopic procedural time will be defined as the time from the first insertion of the colonoscope until it is removed from the anus.

  7. Percentage of Patients Referred to a Specialist.

    Time frame: Within four (4) weeks of colonoscopy

    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).

Sponsors and collaborators

Lead sponsor

University of Alberta

Other

Collaborators

  • Alberta Ministry of Health - Alberta Rural Physician Action Plan

Registry information

Official study title

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

Acronym: APC-Endo

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Mar 23, 2011
Registry last updated
Aug 15, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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