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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04838197
Other study ID # 2021-0045-E
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 3, 2022
Est. completion date October 31, 2023

Study information

Verified date April 2024
Source Women's College Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 25
Est. completion date October 31, 2023
Est. primary completion date October 28, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Questionnaires and Surveys
Quantitative questionnaires will measure and quantify the importance of the various factors (e.g., intensity of dependence, duration of care, health literacy, physical well-being, emotional well-being, social well-being, and financial well-being) that contribute to caregiver burden both preoperatively and postoperatively at 48 hours, 1 week, 2 weeks, and 1 month.

Locations

Country Name City State
Canada Women's College Hospital Toronto Ontario

Sponsors (1)

Lead Sponsor Collaborator
Women's College Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Care-giver experience assessment with homegrown quantitative questionnaires 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
before surgery up to discharge, assessed up to 1 month
Secondary Intensity of patient dependence on the caregiver Using the Katz Index of Independence in Activities of Daily Living at 48 hours, 1 week, 2 weeks, and 1 month post-operatively
Secondary Time expected to care for the patient This section will ask caregivers about the number of hours they spend/expect to spend performing caregiving activities. at 48 hours, 1 week, 2 weeks, and 1 month post-operatively
Secondary Number of people the caregiving responsibilities have been shared with This section will ask caregivers questions focusing on their health literacy, defined as "the ability to obtain, read, understand and use healthcare information". Caregivers will be asked how prepared/confident they feel performing the necessary medical caregiving tasks, and if they have sought out additional medical information from healthcare professionals, or online resources to help assist in a caregiving task. Finally, caregivers will be asked to identify if they have shared the caregiving responsibilities with another person throughout the caregiving experience at 48 hours, 1 week, 2 weeks, and 1 month post-operatively
Secondary Caregivers' preparedness This section will ask caregivers questions focusing on their health literacy, defined as "the ability to obtain, read, understand and use healthcare information". Caregivers will be asked how prepared/confident they feel performing the necessary medical caregiving tasks, and if they have sought out additional medical information from healthcare professionals, or online resources to help assist in a caregiving task. Finally, caregivers will be asked to identify if they have shared the caregiving responsibilities with another person throughout the caregiving experience at 48 hours, 1 week, 2 weeks, and 1 month post-operatively
Secondary Caregivers' reliance on additional medical information to help assist in care-giving This section will ask caregivers questions focusing on their health literacy, defined as "the ability to obtain, read, understand and use healthcare information". Caregivers will be asked how prepared/confident they feel performing the necessary medical caregiving tasks, and if they have sought out additional medical information from healthcare professionals, or online resources to help assist in a caregiving task. Finally, caregivers will be asked to identify if they have shared the caregiving responsibilities with another person throughout the caregiving experience at 48 hours, 1 week, 2 weeks, and 1 month post-operatively
Secondary Caregivers' perceptions on the physical demands of caregiving This section will ask caregivers questions regarding the impact of caregiving on their physical well-being. Caregivers will be asked pre-operatively if they expect caring for the patient will be physically demanding, and post-operatively if caring for the patient has been physically demanding. As well, caregivers will be asked if preparing for/caring for the patient has disrupted their sleep pre-operatively and post-operatively at 48 hours, 1 week, 2 weeks, and 1 month
Secondary Disruption to the caregivers sleep This section will ask caregivers questions regarding the impact of caregiving on their physical well-being. Caregivers will be asked pre-operatively if they expect caring for the patient will be physically demanding, and post-operatively if caring for the patient has been physically demanding. As well, caregivers will be asked if preparing for/caring for the patient has disrupted their sleep pre-operatively and post-operatively at 48 hours, 1 week, 2 weeks, and 1 month
Secondary Presence of depression and anxiety within caregivers To further measure anxiety and depression, caregivers will complete the Hospital Anxiety and Depression Scale (HADS). HADS was designed to be a reliable, valid, and simple to use tool to identify and quantify anxiety and depression. Though the term 'hospital' in the title suggests it only valid in the hospital setting, many studies have confirmed the tools valid use in primary care medical and community settings. HADS is comprised of 14 items, 7 assessing anxiety and 7 assessing depression. pre-operatively and post-operatively at 48 hours, 1 week, 2 weeks, and 1 month
Secondary Disruption to the caregivers' emotional well-being This section will ask caregivers questions regarding the impact of caregiving on their emotional well-being. Caregivers will be asked if preparing for/caring for the patient has disrupted their emotional well-being (e.g., anxious, depressed, irritable, angry, etc.).Each item is rated on a 4-point scale ranging from 0 meaning no not at all, to 3 meaning yes definitely. The total score for each sub scale ranges from 0-21, where 0-7 indicates non-cases, 8-10 indicates mild cases, 11-14 indicates moderate cases, and 15-21 indicates cases of anxiety or depression. pre-operatively and post-operatively at 48 hours, 1 week, 2 weeks, and 1 month
Secondary Disruption to the caregivers' social well-being This section will ask caregivers questions regarding the impact of caregiving on their social well-being. Caregivers will be asked if preparing for/caring for the patient has disrupted their social well-being (e.g., socializing with friends and family, participating in recreational/leisure activities, etc.). pre-operatively and post-operatively at 48 hours, 1 week, 2 weeks, and 1 month
Secondary Presence of financial strain due to caregiving This section will ask caregivers questions regarding the impact of caregiving on their financial health. Caregivers will be asked if preparing for/caring for the patient has caused financial strain. Caregivers will be asked to identify how many days they expect to take off work to care for the patient, and how many days they actually took off work to care for the patient. Likewise, caregivers will be asked how much out of pocket they expect to spend on the patient during the caregiving experience, and then on post-operative 1 month they will be asked how much they actually spent on the patient during the caregiving experience. pre-operatively and post-operatively at 48 hours, 1 week, 2 weeks, and 1 month
Secondary Number of days expected to be taken off work to help care for the patient This section will ask caregivers questions regarding the impact of caregiving on their financial health. Caregivers will be asked if preparing for/caring for the patient has caused financial strain. Caregivers will be asked to identify how many days they expect to take off work to care for the patient, and how many days they actually took off work to care for the patient. Likewise, caregivers will be asked how much out of pocket they expect to spend on the patient during the caregiving experience, and then on post-operative 1 month they will be asked how much they actually spent on the patient during the caregiving experience. pre-operatively, and the actual number of days taken off to help care for the patient at 1 month
Secondary Amount expected to be spent throughout the caregiving experience This section will ask caregivers to identify which factors are contributing the greatest to caregiver burden at various time points throughout the caregiving experience. Caregivers will be asked: "If you were given $1,000 to spend immediately to help ease the caregiving experience, how would you allocate your spending on the following factors?" Caregivers will be able to allocate the money among the seven factors previously mentioned, with hopes that caregivers will be allocating the money to different factors that are contributing significantly to the caregiver burden at various time points. pre-operatively, and the amount spent during the caregiving experience at 1 month
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