Colon Disease, Endoscopy, Screening Test
Conditions
Keywords
colonoscopy, primary care physicians, quality assurance
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.
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.
Interventions
PROCEDUREcolonoscopy
Data pertaining to all colonoscopies performed by a APC-Endo study physician over a two month period will be collected.
Sponsors
Alberta Ministry of Health - Alberta Rural Physician Action Plan
University of Alberta
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Successful Cecal Intubations (Crude) | 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 |
| Percentage of Successful Cecal Intubations (Adjusted) | 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) |
| Adenoma Detection Ratio | 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. |
| Percentage of Males 50 Years and Older Undergoing First Time Colonoscopy With an Adenoma | 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. |
| Percentage of Females 50 Years and Older Undergoing First Time Colonoscopy With an Adenoma | [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
| Measure | Time frame | Description |
|---|---|---|
| Colonoscopy Procedure Time | 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. |
| Colonoscopy Complications: Bleeding, Perforation, Cardiopulmonary Complications Secondary to Conscious Sedation, and Death. | 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. |
| Percentage of Patients Referred to a Specialist. | 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). |
| Colonoscopy Withdraw Time in Cases Where no Lesions Found | 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. |
| Patient Comfort During Colonoscopy | 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; 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 | 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 |
| Patient Satisfaction With Hospital Experience for Colonoscopy | 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 |
Countries
Canada
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 577 |
| Total | 577 |
Baseline characteristics
| Characteristic | Participants. |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 162 Participants |
| Age, Categorical Between 18 and 65 years | 415 Participants |
| Age Continuous | 57.6 years STANDARD_DEVIATION 13.3 |
| Region of Enrollment Canada | 577 participants |
| Sex: Female, Male Female | 295 Participants |
| Sex: Female, Male Male | 282 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 577 |
| serious Total, serious adverse events | 4 / 577 |
Outcome results
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.
Time frame: When pathology from colonoscopy available (on average 2-3 weeks after procedure)
Population: Number of patients who underwent colonoscopy
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Percentage of Successful Cecal Intubations (Crude) | Adenoma Detection Ratio | 0.62 adenomas / 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.
Time frame: [When pathology from colonoscopy available (on average 2-3 weeks after procedure)]
Population: For this outcome, we only examined females ≥ 50 years old having their first colonoscopy
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Percentage of Successful Cecal Intubations (Crude) | Percentage of Females 50 Years and Older Undergoing First Time Colonoscopy With an Adenoma | 30.2 percentage of females |
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.
Time frame: When pathology from colonoscopy available (on average 2-3 weeks after procedure)
Population: We only examined this outcome for males 50 years and older having their first colonoscopy
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Percentage of Successful Cecal Intubations (Crude) | Percentage of Males 50 Years and Older Undergoing First Time Colonoscopy With an Adenoma | 46.4 percentage of males |
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)
Time frame: At time of colonoscopy (DAY 1 of study)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Percentage of Successful Cecal Intubations (Crude) | Percentage of Successful Cecal Intubations (Adjusted) | 96.5 percentage of colonoscopies attempted |
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
Time frame: At time of colonoscopy (DAY 1 of study)
Population: Prospective, observational study, all study participants were analyzed
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Percentage of Successful Cecal Intubations (Crude) | Percentage of Successful Cecal Intubations (Crude) | 95.3 percentage of colonoscopies performed |
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.
Time frame: Within four (4) weeks of colonoscopy
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Percentage of Successful Cecal Intubations (Crude) | Colonoscopy Complications: Bleeding, Perforation, Cardiopulmonary Complications Secondary to Conscious Sedation, and Death. | 4 patients undergoing 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.
Time frame: At time of colonoscopy (DAY 1 of study)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Percentage of Successful Cecal Intubations (Crude) | Colonoscopy Procedure Time | 23.6 minutes |
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.
Time frame: At time of colonoscopy (DAY 1 of study)
Population: Only examined patients in which no lesions were detected.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Percentage of Successful Cecal Intubations (Crude) | Colonoscopy Withdraw Time in Cases Where no Lesions Found | 7 minutes |
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; 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.
Time frame: At time of colonoscopy (DAY 1 of study)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Percentage of Successful Cecal Intubations (Crude) | Patient Comfort During Colonoscopy | 0.8 units on the scale | Standard Deviation 0.79 |
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
Time frame: At patient satisfaction phone survey (on average 4 weeks after colonoscopy)
Population: 443 patients completed the post procedural satisfaction survey.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Percentage of Successful Cecal Intubations (Crude) | Patient Satisfaction With Endoscopy Wait Time | 7 units on a scale |
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
Time frame: At patient satisfaction phone survey (on average 4 weeks after colonoscopy)
Population: 443 patients consented to and completed the post procedural satisfaction survey.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Percentage of Successful Cecal Intubations (Crude) | Patient Satisfaction With Hospital Experience for Colonoscopy | 7 units on a scale |
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).
Time frame: Within four (4) weeks of colonoscopy
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Percentage of Successful Cecal Intubations (Crude) | Percentage of Patients Referred to a Specialist. | 4.8 percentage of patients |