Clinical trial NCT04838197: Understanding Caregiver Burden for Hip and Knee Replacement Surgery Patients
Official title: Understanding Caregiver Burden When Traditional Total Hip and Knee Replacement Surgeries Shift From Inpatient Hospitalization to Outpatient Settings: A Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Caregiver Burnout
Keywords: Total Joint surgeries
Total Knee Arthoplasty
Total Hip Arthoplasty
Lead sponsor: Women's College Hospital
Sponsor class: OTHER
First posted: 2021-04-09
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients undergoing ambulatory TKA or THA will be approached for consent. Their primary caregivers will be consented to participate as well.

Brief summary: Caregiver burden is the response to the emotional, financial, physical, psychological, and social stressors associated with having to care for another family member. Previous studies have looked at the impact of caregiver burden in caregivers caring for loved ones dealing with long-term disease, such as dementia. The research has found that one in three caregivers suffer from depression, and experience high levels of stress and anxiety. However, these findings may not be relatable to the outpatient surgical setting. The purpose of this study is to find out how various factors such as the physical, emotional, social, and financial burden impact caregivers who are responsible for providing care to patients who are undergoing same-day surgical procedures that are traditionally performed as inpatient surgery. By understanding this potential burden on the caregiver, we hope that future healthcare improvements can be made to minimize this impact on the patients and their caregiver.

Detailed description: The extent of caregiver burden in the acute postoperative outpatient settings, immediately following major orthopedic surgery that has traditionally been performed in an inpatient setting, remains unknown. Care giving places a tremendous amount of physical and mental stress onto the caregiver, which may result in the "hidden patient" in the caregiver. It is expected that by 2026, 51% of TJA will be performed as outpatient procedures. Building on the successes of the country's first outpatient TKA program at Women's College Hospital, and with the expansion to include outpatient THA procedures, it is now important to understand whether or not our innovative ambulatory model is simply transferring the burden of postoperative care and recovery from nurses, doctors, and other hospital staff to family members, friends, or privately-employed caregivers.

In the current state of literature, there is inadequate data examining caregiver burden when traditional surgical procedures are shifted to an outpatient setting, therefore, a comprehensive study is required to understand the various dimensions of caregiver burden. Therefore, our research question is "what are the most important factors that contribute to the burden of care for caregivers of patients undergoing outpatient surgical procedures traditionally performed as inpatients?"

This prospective cohort study examines how the various dimensions of caregiver burden impact caregivers at different time points throughout the care giving experience. These dimensions include factors such as the intensity of dependence on the caregiver, duration of care, caregiver specific factors (e.g., the health literacy of the caregiver), and care giving dimensions (e.g., physical, emotional, social and financial burdens). Through gaining an understanding of how the various dimensions of caregiver burden impact caregivers in the outpatient settings, meaningful improvements can be made in the future and ultimately improve the quality of life of the caregiver during the time of care.

Eligibility criteria: Inclusion Criteria (Patient):

* Undergoing ambulatory total knee or total hip arthroplasty
* Patient is able to consent for self

Inclusion Criteria (Caregiver):

* English speaking, or willing to use an interpreter
* Over the age of 18 years
* Primarily responsible for providing care to the patient undergoing ambulatory total knee or total hip arthroplasty

Exclusion Criteria (Patient and Caregiver):

* Refusal or unable to provide informed consent
* The patient is a resident in a nursing home or is already receiving daily professional care for most ADLs
* Unable to complete data collection tools or take part in telephone interviews due to cognitive or physical impairment

Withdrawal Criteria After Enrollment

* Patient or Caregiver refusal to participate or continue with the study at any point
* Cancellation of surgery

Primary outcomes:
measure: Care-giver experience assessment with homegrown quantitative questionnaires
timeFrame: before surgery up to discharge, assessed up to 1 month
Secondary outcomes:
measure: Intensity of patient dependence on the caregiver
timeFrame: at 48 hours, 1 week, 2 weeks, and 1 month post-operatively
measure: Time expected to care for the patient
timeFrame: at 48 hours, 1 week, 2 weeks, and 1 month post-operatively
measure: Number of people the caregiving responsibilities have been shared with
timeFrame: at 48 hours, 1 week, 2 weeks, and 1 month post-operatively
measure: Caregivers' preparedness
timeFrame: at 48 hours, 1 week, 2 weeks, and 1 month post-operatively
measure: Caregivers' reliance on additional medical information to help assist in care-giving
timeFrame: at 48 hours, 1 week, 2 weeks, and 1 month post-operatively
measure: Caregivers' perceptions on the physical demands of caregiving
timeFrame: pre-operatively and post-operatively at 48 hours, 1 week, 2 weeks, and 1 month
measure: Disruption to the caregivers sleep
timeFrame: pre-operatively and post-operatively at 48 hours, 1 week, 2 weeks, and 1 month
measure: Presence of depression and anxiety within caregivers
timeFrame: pre-operatively and post-operatively at 48 hours, 1 week, 2 weeks, and 1 month
measure: Disruption to the caregivers' emotional well-being
timeFrame: pre-operatively and post-operatively at 48 hours, 1 week, 2 weeks, and 1 month
measure: Disruption to the caregivers' social well-being
timeFrame: pre-operatively and post-operatively at 48 hours, 1 week, 2 weeks, and 1 month
measure: Presence of financial strain due to caregiving
timeFrame: pre-operatively and post-operatively at 48 hours, 1 week, 2 weeks, and 1 month
measure: Number of days expected to be taken off work to help care for the patient
timeFrame: pre-operatively, and the actual number of days taken off to help care for the patient at 1 month
measure: Amount expected to be spent throughout the caregiving experience
timeFrame: pre-operatively, and the amount spent during the caregiving experience at 1 month
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Women's College Hospital
state: Ontario
Study officials:
affiliation: Women's College Hospital
name: Richard Brull, MD
role: PRINCIPAL_INVESTIGATOR
References: