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| Name | Class |
|---|---|
| Alberta Ministry of Health - Alberta Rural Physician Action Plan | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| colonoscopy | Procedure | Data pertaining to all colonoscopies performed by a APC-Endo study physician over a two month period will be collected. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Michael R Kolber, MD, CCFP | University of Alberta | Study Director |
| Brian H Rowe, MD, CCFP(EM) | University of Alberta | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Barrhead Healthcare Centre | Barrhead | Alberta | T7N 1M1 | Canada | ||
| Bonnyville Healthcare Centre |
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Patients were enrolled if they were undergoing a colonoscopy for any reason with one of the participating study primary care colonoscopists. Due to staggered local study start dates, data collection occurred between March 15, 2010 and June 14, 2010 and patient satisfaction phone surveys were completed by August 2010.
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| ID | Title | Description |
|---|---|---|
| FG000 | Patients Undergoing Colonoscopy | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Participants. | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Prospective, observational study, all study participants were analyzed | Posted | Number | 95% Confidence Interval | percentage of colonoscopies performed | At time of colonoscopy (DAY 1 of study) |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Participants. | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Perforation | Gastrointestinal disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Michael Kolber | University of Alberta | (780) 616-8411 | mkolber@ualberta.ca |
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| ID | Term |
|---|---|
| D003108 | Colonic Diseases |
| ID | Term |
|---|---|
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D003113 | Colonoscopy |
| ID | Term |
|---|---|
| D016099 | Endoscopy, Gastrointestinal |
| D016145 | Endoscopy, Digestive System |
| D003938 | Diagnostic Techniques, Digestive System |
| D019937 | Diagnostic Techniques and Procedures |
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| [When pathology from colonoscopy available (on average 2-3 weeks after procedure)] |
| Within four (4) weeks of colonoscopy |
| 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) |
| 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;
Minimum value = 0, maximum value = 4 with 4 being worse. | At time of colonoscopy (DAY 1 of study) |
| 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) |
| 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) |
| 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) |
| 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 |
| Bonnyville |
| Alberta |
| T9N 1M3 |
| Canada |
| St. Mary's Hospital | Camrose | Alberta | T4V 1Y5 | Canada |
| Daysland Health Centre | Daysland | Alberta | T08 1A0 | Canada |
| Queen Elizabeth 2 Hospital | Grande Prairie | Alberta | T8V 0N5 | Canada |
| William J. Cadzow Health Centre | Lac La Biche | Alberta | T0A 2C0 | Canada |
| Sacred Heart Hospital | McLennan | Alberta | T0H 2L0 | Canada |
| Peace River Community Health Centre | Peace River | Alberta | T8S 1T6 | Canada |
| Pincher Creek Hospital | Pincher Creek | Alberta | T0K 1W0 | Canada |
| Ponoka Hospital and Care Centre | Ponoka | Alberta | T4J 1P1 | Canada |
| Sturgeon Community Hospital | St. Albert | Alberta | T8N 6C4 | Canada |
| Taber Hospital | Taber | Alberta | T1G 1N9 | Canada |
| Whitecourt Healthcare Centre | Whitecourt | Alberta | T7S 1M8 | Canada |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| 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) | Posted | Number | 95% Confidence Interval | percentage of colonoscopies attempted | At time of colonoscopy (DAY 1 of study) |
|
|
|
| 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. | Number of patients who underwent colonoscopy | Posted | Number | 95% Confidence Interval | adenomas / colonoscopy | When pathology from colonoscopy available (on average 2-3 weeks after procedure) |
|
|
|
| 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. | We only examined this outcome for males 50 years and older having their first colonoscopy | Posted | Mean | 95% Confidence Interval | percentage of males | When pathology from colonoscopy available (on average 2-3 weeks after procedure) |
|
|
|
| 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. | Posted | Number | patients undergoing colonoscopy | Within four (4) weeks of colonoscopy |
|
|
|
| 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. | Only examined patients in which no lesions were detected. | Posted | Mean | 95% Confidence Interval | minutes | At time of colonoscopy (DAY 1 of study) |
|
|
|
| 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;
Minimum value = 0, maximum value = 4 with 4 being worse. | Posted | Mean | Standard Deviation | units on the scale | At time of colonoscopy (DAY 1 of study) |
|
|
|
| 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 | 443 patients completed the post procedural satisfaction survey. | Posted | Median | Inter-Quartile Range | units on a scale | At patient satisfaction phone survey (on average 4 weeks after colonoscopy) |
|
|
|
| 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 | 443 patients consented to and completed the post procedural satisfaction survey. | Posted | Median | Inter-Quartile Range | units on a scale | At patient satisfaction phone survey (on average 4 weeks after colonoscopy) |
|
|
|
| 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. | Posted | Mean | 95% Confidence Interval | minutes | At time of colonoscopy (DAY 1 of study) |
|
|
|
| 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). | Posted | Number | percentage of patients | Within four (4) weeks of colonoscopy |
|
|
|
| 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. | For this outcome, we only examined females ≥ 50 years old having their first colonoscopy | Posted | Mean | 95% Confidence Interval | percentage of females | [When pathology from colonoscopy available (on average 2-3 weeks after procedure)] |
|
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|
| 4 |
| 577 |
| 0 |
| 577 |
| Bleeding | Gastrointestinal disorders | Systematic Assessment |
|
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| D003933 | Diagnosis |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |