NCT02550886

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

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2015

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 31, 2015

Completed
16 days until next milestone

First Posted

Study publicly available on registry

September 16, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

December 1, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 10, 2016

Completed
Last Updated

April 1, 2022

Status Verified

March 1, 2022

Enrollment Period

3 months

First QC Date

August 31, 2015

Last Update Submit

March 31, 2022

Conditions

Keywords

Work BurdenAmbulatory Orthopedic SurgeryAnesthesiologyPerioperative Care

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

Other: Survey

Interventions

SurveyOTHER

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.

Patient/Caregiver Dyad

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

Location

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: 15525613BACKGROUND
  • 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.

    PMID: 9311400BACKGROUND

MeSH Terms

Conditions

Stress, PsychologicalPain

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Kanupriya Kumar, MD

    Hospital for Special Surgery, New York

    PRINCIPAL INVESTIGATOR

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

Locations