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Clinical Trials/NCT04838197
NCT04838197
Completed
Not Applicable

Understanding Caregiver Burden When Traditional Total Hip and Knee Replacement Surgeries Shift From Inpatient Hospitalization to Outpatient Settings: A Prospective Cohort Study

Women's College Hospital1 site in 1 country25 target enrollmentMarch 3, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Caregiver Burnout
Sponsor
Women's College Hospital
Enrollment
25
Locations
1
Primary Endpoint
Care-giver experience assessment with homegrown quantitative questionnaires
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 3, 2022
End Date
October 31, 2023
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Care-giver experience assessment with homegrown quantitative questionnaires

Time Frame: before surgery up to discharge, assessed up to 1 month

To gain an understanding of the various factors contributing to the burden of care experienced in the post-operative setting among our caregivers caring for patients undergoing TKA or THA within our ambulatory model. (e.g., intensity of dependence, duration of care, health literacy, physical well-being, emotional well-being, social well-being, and financial well-being) On a scale of 5-Point Likert Scale from Strongly Disagree to Strongly Agree

Secondary Outcomes

  • Time expected to care for the patient(at 48 hours, 1 week, 2 weeks, and 1 month post-operatively)
  • Disruption to the caregivers sleep(pre-operatively and post-operatively at 48 hours, 1 week, 2 weeks, and 1 month)
  • Presence of depression and anxiety within caregivers(pre-operatively and post-operatively at 48 hours, 1 week, 2 weeks, and 1 month)
  • Caregivers' perceptions on the physical demands of caregiving(pre-operatively and post-operatively at 48 hours, 1 week, 2 weeks, and 1 month)
  • Number of people the caregiving responsibilities have been shared with(at 48 hours, 1 week, 2 weeks, and 1 month post-operatively)
  • Presence of financial strain due to caregiving(pre-operatively and post-operatively at 48 hours, 1 week, 2 weeks, and 1 month)
  • Amount expected to be spent throughout the caregiving experience(pre-operatively, and the amount spent during the caregiving experience at 1 month)
  • Disruption to the caregivers' social well-being(pre-operatively and post-operatively at 48 hours, 1 week, 2 weeks, and 1 month)
  • Intensity of patient dependence on the caregiver(at 48 hours, 1 week, 2 weeks, and 1 month post-operatively)
  • Caregivers' preparedness(at 48 hours, 1 week, 2 weeks, and 1 month post-operatively)
  • Caregivers' reliance on additional medical information to help assist in care-giving(at 48 hours, 1 week, 2 weeks, and 1 month post-operatively)
  • Disruption to the caregivers' emotional well-being(pre-operatively and post-operatively at 48 hours, 1 week, 2 weeks, and 1 month)
  • Number of days expected to be taken off work to help care for the patient(pre-operatively, and the actual number of days taken off to help care for the patient at 1 month)

Study Sites (1)

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