Study Stopped
Lost many participants to follow-up.
Anticipated Versus Actual Patient and Caregiver Burden Following Ambulatory Orthopedic Surgery
Work Burden
1 other identifier
observational
28
1 country
1
Brief Summary
In 2011, 38.6 million hospital stays occurred in the United States at a cost of $387.2 billion. 47.9 percent involved hospitalizations during which surgical procedures were performed. Orthopedic procedures constituted the most frequently performed and most costly of operating room procedures. As the healthcare climate in the United States continues to change, there is a trend towards providing effective care in a fiscally conservative manner. Central to this strategy is the shift towards increasing ambulatory surgical procedures from surgeries requiring post-operative admission for patients. While savings to hospitals and third-party payers are implied, there may be an unrecognized increase in financial, physical, and psychosocial post-operative costs to patients undergoing ambulatory surgery and to their caregivers. Rawal et al., and McGarth and colleagues have found that patients undergoing orthopedic procedures had moderate to severe post-operative pain. We propose to present a survey to patients and their caregivers before surgery and at multiple timepoints post-operatively to acquire information on the impacts of ambulatory orthopedic surgery. In addition to assessing post-operative pain, this study serves to examine various other possible burdens to patients that have not been previously evaluated in this patient population. REFERENCES McGarth B, Elgendy H, Chung F, Kamming D, Curti B, King S. Thirty percent of patients have a moderate to severe pain 24 hr after ambulatory surgery: a survey of 5,703 patients. Can J Anesth. 2004; 51:886-891. Rawal N, Hylander J, Nydahl P, Olofsson I, Gupta A. Survey of postoperative analgesia following ambulatory surgery. Acta Anesthesiol Scand. 1997; 41:1017-1022.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Dec 2015
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 31, 2015
CompletedFirst Posted
Study publicly available on registry
September 16, 2015
CompletedStudy Start
First participant enrolled
December 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
March 10, 2016
CompletedApril 1, 2022
March 1, 2022
3 months
August 31, 2015
March 31, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time taken off from work--specifically, the number of extra days taken off from work by patients and their caregivers after surgery
Patients and caregivers will be considered able to return to their baseline level of work once they can fulfill all responsibilities at their current occupation with no restrictions.
Holding area before surgery, post-operative day 1 (POD 1), POD 7, biweekly thereafter until patient returns to baseline level of work, and two weeks after patient returns to baseline level of work
Secondary Outcomes (2)
Expected Burden of Recovery
Holding area before surgery, post-operative day 1 (POD 1), POD 7, biweekly thereafter until patient returns to baseline level of work, and two weeks after patient returns to baseline level of work
Excess (Actual Beyond Expected) Burden of Recovery
Holding area before surgery, post-operative day 1 (POD 1), POD 7, biweekly thereafter until patient returns to baseline level of work, and two weeks after patient returns to baseline level of work
Study Arms (1)
Patient/Caregiver Dyad
Interventions
Patients and their caregivers will be asked to complete surveys about their expected and actual time taken off from work. They will also answer questions about the patient's recovery, as well as the patient/caregiver relationship.
Eligibility Criteria
Patients undergoing outpatient arthroscopic knee debridement or meniscectomy surgery at Hospital for Special Surgery
You may qualify if:
- Patients undergoing outpatient arthroscopic knee debridement or meniscectomy surgery
- Age 18-85
- Primary caregiver available during preoperative period who is employed full-time or part-time
- English speaking
- Patients who are employed full-time or part-time
You may not qualify if:
- Patients on disability or worker's compensation
- Patients undergoing concurrent procedures
- Patients who are self-employed
- Caregivers who are self-employed
- Surgeons: Dr. Altchek, Dr. Warren, Dr. O'Brien
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital for Special Surgery (HSS)
New York, New York, 10021, United States
Related Publications (2)
McGrath B, Elgendy H, Chung F, Kamming D, Curti B, King S. Thirty percent of patients have moderate to severe pain 24 hr after ambulatory surgery: a survey of 5,703 patients. Can J Anaesth. 2004 Nov;51(9):886-91. doi: 10.1007/BF03018885.
PMID: 15525613BACKGROUNDRawal N, Hylander J, Nydahl PA, Olofsson I, Gupta A. Survey of postoperative analgesia following ambulatory surgery. Acta Anaesthesiol Scand. 1997 Sep;41(8):1017-22. doi: 10.1111/j.1399-6576.1997.tb04829.x.
PMID: 9311400BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kanupriya Kumar, MD
Hospital for Special Surgery, New York
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 31, 2015
First Posted
September 16, 2015
Study Start
December 1, 2015
Primary Completion
March 1, 2016
Study Completion
March 10, 2016
Last Updated
April 1, 2022
Record last verified: 2022-03
Data Sharing
- IPD Sharing
- Will not share