Activities of Daily Living, Ambulatory Surgical Procedures, Caregivers
Conditions
Keywords
Activities of Daily Living, Caregivers, Ambulatory Surgical Procedures
Brief summary
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: 1. 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: 2. 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. 3. Changes in functional capacity are correlated with decrements in quality of life as assessed by the Short Form 12 (SF12). 4. Changes in functional capacity are correlated with inadequate postoperative analgesia as assessed by the Brief Pain Inventory (BPI).
Interventions
None listed
Sponsors
Canadian Anesthesiologists' Society
Ottawa Hospital Research Institute
Study design
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients * aged 65 years and older * elective surgery with a planned discharge to the community on the day of the surgical procedure. * Eligible surgical procedures include: inguinal herniorrhaphy, ventral herniorrhaphy, laparoscopic cholecystectomy,laparoscopic salpingoophorectomy, urethropexy, cystocoele/rectocoele repair, vaginal hysterectomy, arthroscopic debridement (knee, hip, shoulder), arthroscopic repair (knee, hip, shoulder), removal of hardware from lower extremity, foot surgery, and lumbar discectomy. Caregiver \- spouses, family members, or friends identified as the patient's primary source of support in the community.
Exclusion criteria
Patients * Reside in a nursing home providing professional support services; * Are unable to complete the study instruments due to cognitive (MMSE \<24) or physical impairment; * Are unable to speak English or French Caregiver * Professional caregivers (nurse, personal care assistant, etc) hired to care for the patient; * Unable to complete the study instruments due to physical impairment; * Unable to Speak English or French
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Functional Autonomy Measurement System (SMAF) | Baseline, one week, and one month following surgery | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Zarit Burden Interview (ZBI) | Baseline, one week, and one month following surgery | 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. |
| Short Form 12 | Baseline, one week, and one month following surgery | 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. |
| Brief Pain Inventory (BPI) Functional Interference Score. | Baseline, one week, and one month following surgery | 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. |
Countries
Canada
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Ambulatory Surgery Patients Only patients with caregivers were recruited | 102 |
| Ambulatory Surgery Caregivers Caregivers were recruited with the patients receiving surgery | 102 |
| Total | 204 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Contacted after study closed | 1 | 1 |
| Overall Study | Lost to Follow-up | 4 | 4 |
| Overall Study | Surgeries cancelled or delayed | 16 | 16 |
Baseline characteristics
| Characteristic | Ambulatory Surgery Patients | Ambulatory Surgery Caregivers | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 102 Participants | 72 Participants | 174 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 30 Participants | 30 Participants |
| Region of Enrollment Canada | 102 participants | 102 participants | 204 participants |
| Sex: Female, Male Female | 54 Participants | 55 Participants | 109 Participants |
| Sex: Female, Male Male | 48 Participants | 47 Participants | 95 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 102 |
| serious Total, serious adverse events | 4 / 102 |
Outcome results
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
Time frame: Baseline, one week, and one month following surgery
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ambulatory Surgery Patients | Functional Autonomy Measurement System (SMAF) | Baseline | 4.0 units on a scale | Standard Deviation 5.9 |
| Ambulatory Surgery Patients | Functional Autonomy Measurement System (SMAF) | One Week Post-op | 10.9 units on a scale | Standard Deviation 7.6 |
| Ambulatory Surgery Patients | Functional Autonomy Measurement System (SMAF) | One Month Post-op | 6.7 units on a scale | Standard Deviation 7.2 |
| Ambulatory Surgery Caregivers | Functional Autonomy Measurement System (SMAF) | Baseline | 2.0 units on a scale | Standard Deviation 2.9 |
| Ambulatory Surgery Caregivers | Functional Autonomy Measurement System (SMAF) | One Week Post-op | NA units on a scale | — |
| Ambulatory Surgery Caregivers | Functional Autonomy Measurement System (SMAF) | One Month Post-op | NA units on a scale | — |
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.
Time frame: Baseline, one week, and one month following surgery
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ambulatory Surgery Patients | Brief Pain Inventory (BPI) Functional Interference Score. | Baseline | 1.8 units on a scale | Standard Deviation 2.4 |
| Ambulatory Surgery Patients | Brief Pain Inventory (BPI) Functional Interference Score. | One Week Post-op | 2.1 units on a scale | Standard Deviation 2.1 |
| Ambulatory Surgery Patients | Brief Pain Inventory (BPI) Functional Interference Score. | One Month Post-op | 1.2 units on a scale | Standard Deviation 1.7 |
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.
Time frame: Baseline, one week, and one month following surgery
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ambulatory Surgery Patients | Short Form 12 | Mental Component Score (One Week Post-op) | 54.9 units on a scale | Standard Deviation 8.8 |
| Ambulatory Surgery Patients | Short Form 12 | Physical Component Score (Baseline) | 43.4 units on a scale | Standard Deviation 12.7 |
| Ambulatory Surgery Patients | Short Form 12 | Mental Component Score (Baseline) | 55.3 units on a scale | Standard Deviation 7.5 |
| Ambulatory Surgery Patients | Short Form 12 | Physical Component Score (One Week Post-op) | 35.1 units on a scale | Standard Deviation 10.3 |
| Ambulatory Surgery Patients | Short Form 12 | Mental Component Score (One Month Post-Op) | 56.2 units on a scale | Standard Deviation 7.8 |
| Ambulatory Surgery Patients | Short Form 12 | Physical Component Score (One Month Post-op) | 42.7 units on a scale | Standard Deviation 11.4 |
| Ambulatory Surgery Caregivers | Short Form 12 | Mental Component Score (One Month Post-Op) | 54.8 units on a scale | Standard Deviation 8 |
| Ambulatory Surgery Caregivers | Short Form 12 | Mental Component Score (Baseline) | 55.9 units on a scale | Standard Deviation 6.6 |
| Ambulatory Surgery Caregivers | Short Form 12 | Mental Component Score (One Week Post-op) | 54.4 units on a scale | Standard Deviation 9 |
| Ambulatory Surgery Caregivers | Short Form 12 | Physical Component Score (One Month Post-op) | 51.3 units on a scale | Standard Deviation 8.9 |
| Ambulatory Surgery Caregivers | Short Form 12 | Physical Component Score (Baseline) | 50.5 units on a scale | Standard Deviation 7.9 |
| Ambulatory Surgery Caregivers | Short Form 12 | Physical Component Score (One Week Post-op) | 51.2 units on a scale | Standard Deviation 8.4 |
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.
Time frame: Baseline, one week, and one month following surgery
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ambulatory Surgery Caregivers | Zarit Burden Interview (ZBI) | Baseline | 9.3 units on a scale | Standard Deviation 9.9 |
| Ambulatory Surgery Caregivers | Zarit Burden Interview (ZBI) | One Week Post-op | 8.9 units on a scale | Standard Deviation 9.8 |
| Ambulatory Surgery Caregivers | Zarit Burden Interview (ZBI) | One Month Post-Op | 8.6 units on a scale | Standard Deviation 10.6 |