Clinical trial NCT02550886: Anticipated Versus Actual Patient and Caregiver Burden Following Ambulatory Orthopedic Surgery
Official title: Anticipated Versus Actual Patient and Caregiver Burden Following Ambulatory Orthopedic Surgery
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Stress, Psychological
Pain
Keywords: Work Burden
Ambulatory Orthopedic Surgery
Anesthesiology
Perioperative Care
Lead sponsor: Hospital for Special Surgery, New York
Sponsor class: OTHER
First posted: 2015-09-16
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing outpatient arthroscopic knee debridement or meniscectomy surgery at Hospital for Special Surgery

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.


Eligibility criteria: 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

Primary outcomes:
measure: Time taken off from work--specifically, the number of extra days taken off from work by patients and their caregivers after surgery
timeFrame: 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:
measure: Expected Burden of Recovery
timeFrame: 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
measure: Excess (Actual Beyond Expected) Burden of Recovery
timeFrame: 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
Other outcomes:
Locations:
city: New York
country: United States
facility: Hospital for Special Surgery (HSS)
state: New York
Study officials:
affiliation: Hospital for Special Surgery, New York
name: Kanupriya Kumar, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Rawal 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.