- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04838197
Understanding Caregiver Burden for Hip and Knee Replacement Surgery Patients
Understanding Caregiver Burden When Traditional Total Hip and Knee Replacement Surgeries Shift From Inpatient Hospitalization to Outpatient Settings: A Prospective Cohort Study
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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Ontario
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Toronto, Ontario, Canada, M5S 1B2
- Recruiting
- Women's College Hospital
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Contact:
- Richard Brull, MD
- Phone Number: 4239 416-323-6400
- Email: richard.brull@wchospital.ca
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Contact:
- Didem Bozak
- Phone Number: 6008 416-323-6400
- Email: didem.bozak@wchospital.ca
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Caregiver
If the caregiver agrees and consents to participating in the study, basic demographic and social data will be collected at baseline.
The caregiver will also complete the caregiver burden questionnaire via telephone call at five different time points: pre-operatively, and post-operative 48 hours, 1 week, 2 weeks, and 1 month.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Care-giver experience assessment with homegrown quantitative questionnaires
Time Frame: before surgery up to discharge, assessed up to 1 month
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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
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Intensity of patient dependence on the caregiver
Time Frame: at 48 hours, 1 week, 2 weeks, and 1 month post-operatively
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Using the Katz Index of Independence in Activities of Daily Living
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at 48 hours, 1 week, 2 weeks, and 1 month post-operatively
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Time expected to care for the patient
Time Frame: at 48 hours, 1 week, 2 weeks, and 1 month post-operatively
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This section will ask caregivers about the number of hours they spend/expect to spend performing caregiving activities.
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at 48 hours, 1 week, 2 weeks, and 1 month post-operatively
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Number of people the caregiving responsibilities have been shared with
Time Frame: at 48 hours, 1 week, 2 weeks, and 1 month post-operatively
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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
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at 48 hours, 1 week, 2 weeks, and 1 month post-operatively
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Caregivers' preparedness
Time Frame: at 48 hours, 1 week, 2 weeks, and 1 month post-operatively
|
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
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at 48 hours, 1 week, 2 weeks, and 1 month post-operatively
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Caregivers' reliance on additional medical information to help assist in care-giving
Time Frame: at 48 hours, 1 week, 2 weeks, and 1 month post-operatively
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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
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at 48 hours, 1 week, 2 weeks, and 1 month post-operatively
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Caregivers' perceptions on the physical demands of caregiving
Time Frame: pre-operatively and post-operatively at 48 hours, 1 week, 2 weeks, and 1 month
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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
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pre-operatively and post-operatively at 48 hours, 1 week, 2 weeks, and 1 month
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Disruption to the caregivers sleep
Time Frame: pre-operatively and post-operatively at 48 hours, 1 week, 2 weeks, and 1 month
|
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
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pre-operatively and post-operatively at 48 hours, 1 week, 2 weeks, and 1 month
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Presence of depression and anxiety within caregivers
Time Frame: pre-operatively and post-operatively at 48 hours, 1 week, 2 weeks, and 1 month
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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.
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pre-operatively and post-operatively at 48 hours, 1 week, 2 weeks, and 1 month
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Disruption to the caregivers' emotional well-being
Time Frame: pre-operatively and post-operatively at 48 hours, 1 week, 2 weeks, and 1 month
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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.
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pre-operatively and post-operatively at 48 hours, 1 week, 2 weeks, and 1 month
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Disruption to the caregivers' social well-being
Time Frame: pre-operatively and post-operatively at 48 hours, 1 week, 2 weeks, and 1 month
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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.).
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pre-operatively and post-operatively at 48 hours, 1 week, 2 weeks, and 1 month
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Presence of financial strain due to caregiving
Time Frame: pre-operatively and post-operatively at 48 hours, 1 week, 2 weeks, and 1 month
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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.
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pre-operatively and post-operatively at 48 hours, 1 week, 2 weeks, and 1 month
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Number of days expected to be taken off work to help care for the patient
Time Frame: pre-operatively, and the actual number of days taken off to help care for the patient at 1 month
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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.
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pre-operatively, and the actual number of days taken off to help care for the patient at 1 month
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Amount expected to be spent throughout the caregiving experience
Time Frame: pre-operatively, and the amount spent during the caregiving experience at 1 month
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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.
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pre-operatively, and the amount spent during the caregiving experience at 1 month
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2021-0045-E
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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