Clinical trial NCT01382251: Functional Recovery and Caregiver Burden Following Surgery in the Elderly
Official title: Functional Recovery and Caregiver Burden Following Surgery in the Elderly
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Activities of Daily Living
Caregivers
Ambulatory Surgical Procedures
Keywords: Activities of Daily Living
Caregivers
Ambulatory Surgical Procedures
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
Collaborators: name: Canadian Anesthesiologists' Society
First posted: 2011-06-27
Enrollment: 123
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients undergoing ambulatory surgery and their primary caregivers

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).


Eligibility criteria: 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

Primary outcomes:
measure: Functional Autonomy Measurement System (SMAF)
timeFrame: Baseline, one week, and one month following surgery
Secondary outcomes:
measure: Zarit Burden Interview (ZBI)
timeFrame: Baseline, one week, and one month following surgery
measure: Short Form 12
timeFrame: Baseline, one week, and one month following surgery
measure: Brief Pain Inventory (BPI) Functional Interference Score.
timeFrame: Baseline, one week, and one month following surgery
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: The Ottawa Hospital
state: Ontario
Study officials:
affiliation: Department of Anesthesiology, The Ottawa Hospital
name: Gregory L Bryson, FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.