Anticipated Versus Actual Patient and Caregiver Burden Following Ambulatory Orthopedic Surgery

Terminated

• Conditions: Pain; Stress, Psychological
• Interventions: Other: Survey

• Registration Number: NCT02550886
• Lead Sponsor: Hospital for Special Surgery, New York

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-08-31
• Study First Submitted QC: 2015-09-14
• Study First Posted: 2015-09-16
• Study Start: 2015-12
• Primary Completion: 2016-03
• Study Completion: 2016-03-10
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-31
• Last Update Posted: 2022-04-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patient/Caregiver Dyad	Survey	-

Primary Outcome Measures

Name	Time	Method
Time taken off from work--specifically, the number of extra days taken off from work by patients and their caregivers after surgery	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	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.

Secondary Outcome Measures

Name	Time	Method
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	1. Patient: pain, nausea, vomiting, doctor appointments/hospital visits, days to return to daily activities, days to achieve recovery, days missed from work, emotional duress; 2. Caregiver: days missed from work; days to return to daily activities; emotional duress; productivity, sleep, work and personal adjustments
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	1. Patient: pain, nausea, vomiting, doctor appointments/hospital visits, days to return to daily activities, days to achieve recovery beyond expected, days missed from work, emotional duress; 2. Caregiver: days missed from work; days to return to daily activities; emotional duress; productivity, sleep, work and personal adjustments

Trial Locations

Locations (1)

Hospital for Special Surgery (HSS); 🇺🇸 New York, New York, United States