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| Name | Class |
|---|---|
| Canadian Anesthesiologists' Society | OTHER |
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The purpose of this study is to assess the functional recovery of older ambulatory surgical patients and the impact of the current model of care on the caregivers of these patients. This study will provide unique insight into the challenges patients and their families face following surgery.
The primary objective of this study is to:
Assess the impact of ambulatory surgery on functional capacity as assessed by the Système de Mesure de l'Autonomie Fonctionnelle (SMAF) one week and one month following surgery in a population of surgical patients 65 years of age and older.
Secondary objectives are to determine if:
Changes in the patient's functional capacity result in increased burden of care as assessed by the Zarit Burden Interview (ZBI) in the patient's primary caregiver.
Changes in functional capacity are correlated with decrements in quality of life as assessed by the Short Form 12 (SF12).
Changes in functional capacity are correlated with inadequate postoperative analgesia as assessed by the Brief Pain Inventory (BPI).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patient | Patients undergoing ambulatory surgery | ||
| Caregiver | Spouse, family members, or friends identified as the patient's primary source of support in the community. |
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| Measure | Description | Time Frame |
|---|---|---|
| Functional Autonomy Measurement System (SMAF) | 29-item scale, each item graded on a four-point scale. 0= independent, 1= needs supervision,2 = needs help, 3 = dependent. Total score ranges from 0 to 87 with higher scores indicating increased disability | Baseline, one week, and one month following surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Zarit Burden Interview (ZBI) | A 22-item questionnaire in which subjects rate how often they experience negative feelings associated with caregiving. Each item rated on a 5 point scale anchored at 0 for "never" and 4 for "nearly always." Scores range from 0-88 with higher scores indicating increased burden of care. | Baseline, one week, and one month following surgery |
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Inclusion Criteria:
Patients
Caregiver
- spouses, family members, or friends identified as the patient's primary source of support in the community.
Exclusion Criteria:
Patients
Caregiver
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Patients undergoing ambulatory surgery and their primary caregivers
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| Name | Affiliation | Role |
|---|---|---|
| Gregory L Bryson, FRCPC | Department of Anesthesiology, The Ottawa Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Ottawa Hospital | Ottawa | Ontario | K1Y 4E9 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23771742 | Result | Bryson GL, Clavel NA, Moga R, Power B, Taljaard M, Nathan HJ. Patient function and caregiver burden after ambulatory surgery: a cohort study of patients older than 65. Can J Anaesth. 2013 Sep;60(9):864-73. doi: 10.1007/s12630-013-9982-y. Epub 2013 Jun 15. | |
| 25200593 | Derived | Bryson GL, Mercer C, Varpio L. Patient and caregiver experience following ambulatory surgery: qualitative analysis in a cohort of patients 65 yr and older. Can J Anaesth. 2014 Nov;61(11):986-94. doi: 10.1007/s12630-014-0229-3. Epub 2014 Sep 9. |
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Patients > 65 yrs scheduled to undergo elective ambulatory orthopedic or peritoneal surgeries were assessed for eligibility. Each patient must have a partner or adult descendant as primary caregiver. Patient-caregiver dyads were approached in the pre-admission unit. Screening began on 2010-07-01 and the final assessment was completed on 2012-01-04.
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| ID | Title | Description |
|---|---|---|
| FG000 | Ambulatory Surgery Patients | |
| FG001 | Ambulatory Surgery Caregivers |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Demographic characteristics shown for those patients and caregivers completing study
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| ID | Title | Description |
|---|---|---|
| BG000 | Ambulatory Surgery Patients | Only patients with caregivers were recruited |
| BG001 | Ambulatory Surgery Caregivers | Caregivers were recruited with the patients receiving surgery |
| 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 | Functional Autonomy Measurement System (SMAF) | 29-item scale, each item graded on a four-point scale. 0= independent, 1= needs supervision,2 = needs help, 3 = dependent. Total score ranges from 0 to 87 with higher scores indicating increased disability | Posted | Mean | Standard Deviation | units on a scale | Baseline, one week, and one month following surgery |
|
|
30 days following surgery
Adverse event data not collected on caregivers as they did not undergo surgery.
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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 | Ambulatory Surgery Patients |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myocardial Infarction | Cardiac disorders | Non-systematic Assessment |
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Single center, relatively infrequent assessment, assessment of caregiver burden limited to primary caregiver, majority of caregivers were not employed outside the home.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Gregory L Bryson | Department of Anesthesiology, The Ottawa Hospital | 613.761.4169 | glbryson@ottawahospital.on.ca |
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| Short Form 12 | A validated measure of health related quality of life comprised of 12 questions regarding participant experience over the preceding week. Generate Physical And Mental Component scores ranging from 0-100 with higher scores indicating better quality of life. | Baseline, one week, and one month following surgery |
| Brief Pain Inventory (BPI) Functional Interference Score. | Comprised of seven questions in which the subject is asked to describe the extent to which pain interferes with activity. Scores are anchored at 0 for "does not interfere" and 10 for "completely interferes." The seven resulting scores are averaged and reported as a single value (0 - 10) with higher scores indicating greater interference with function. | Baseline, one week, and one month following surgery |
| Contacted after study closed |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Zarit Burden Interview (ZBI) | A 22-item questionnaire in which subjects rate how often they experience negative feelings associated with caregiving. Each item rated on a 5 point scale anchored at 0 for "never" and 4 for "nearly always." Scores range from 0-88 with higher scores indicating increased burden of care. | Posted | Mean | Standard Deviation | units on a scale | Baseline, one week, and one month following surgery |
|
|
|
| Secondary | Short Form 12 | A validated measure of health related quality of life comprised of 12 questions regarding participant experience over the preceding week. Generate Physical And Mental Component scores ranging from 0-100 with higher scores indicating better quality of life. | Posted | Mean | Standard Deviation | units on a scale | Baseline, one week, and one month following surgery |
|
|
|
| Secondary | Brief Pain Inventory (BPI) Functional Interference Score. | Comprised of seven questions in which the subject is asked to describe the extent to which pain interferes with activity. Scores are anchored at 0 for "does not interfere" and 10 for "completely interferes." The seven resulting scores are averaged and reported as a single value (0 - 10) with higher scores indicating greater interference with function. | Posted | Mean | Standard Deviation | units on a scale | Baseline, one week, and one month following surgery |
|
|
|
| 4 |
| 102 |
| 0 |
| 102 |
| Transient Ischemic Attack | Nervous system disorders | Non-systematic Assessment |
|
| Uncontrolled Pain | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Small Bowel Perforation | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
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| Title | Measurements |
|---|---|
|
| Mental Component Score (One Month Post-Op) |
|
| Physical Component Score (Baseline) |
|
| Physical Component Score (One Week Post-op) |
|
| Physical Component Score (One Month Post-op) |
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| Title | Measurements |
|---|---|
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