Anticipated Versus Actual Patient and Caregiver Burden Following Ambulatory Orthopedic Surgery

Pain Clinical Trial

— Work Burden  

Official title:

Anticipated Versus Actual Patient and Caregiver Burden Following Ambulatory Orthopedic Surgery

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02550886
• Other study ID #: 2014-395
• Status: Terminated
• Start date: December 2015
• Est. completion date: March 10, 2016

Study information

• Verified date: March 2022
• Source: Hospital for Special Surgery, New York
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 28
• Est. completion date: March 10, 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Caregiver Burden
• Pain
• Stress, Psychological

Intervention

Other:
• Survey
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.

Locations

Country	Name	City	State
United States	Hospital for Special Surgery (HSS)	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Hospital for Special Surgery, New York

Country where clinical trial is conducted

United States, 

References & 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Expected Burden of Recovery	Patient: pain, nausea, vomiting, doctor appointments/hospital visits, days to return to daily activities, days to achieve recovery, days missed from work, emotional duress; Caregiver: days missed from work; days to return to daily activities; emotional duress; productivity, sleep, work and personal adjustments	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	Excess (Actual Beyond Expected) Burden of Recovery	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; Caregiver: days missed from work; days to return to daily activities; emotional duress; productivity, sleep, work and personal adjustments	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