Stress, PsychologicalWork BurdenNCT02550886
Anticipated Versus Actual Patient and Caregiver Burden Following Ambulatory Orthopedic Surgery
An observational study of Stress, Psychological and Pain, run by Hospital for Special Surgery, New York at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Stress, Psychological, Pain
- What is being tested?
- Survey
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2015to 10 Mar 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing outpatient arthroscopic knee debridement or meniscectomy surgery at Hospital for Special Surgery
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Hospital for Special Surgery (HSS)
New York, New York, 10021
About this study
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
Read more
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.
- Conditions
- Stress, Psychological, Pain
- Being tested
- Survey
- Keywords
- Work Burden, Ambulatory Orthopedic Surgery, Anesthesiology, Perioperative Care
- Medical subject headings
- Stress, Psychological, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Patient/Caregiver Dyad | Not described Receives: Other: Survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
- 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
Measured: 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
- 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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2015 (estimated)
- Study startDec 2015
- Primary completionMar 2016
- Study completion10 Mar 2016
Why it stopped: Lost many participants to follow-up.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Stress, PsychologicalStudies of the same condition, open and under way.
- More trials run by Hospital for Special Surgery, New YorkThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital for Special Surgery, New York
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kanupriya Kumar, MD, Principal investigator, Hospital for Special Surgery, New York
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02550886
- Sponsor's protocol ID
- 2014-395
- Acronym
- Work Burden
- Status last verified
- Mar 2022
- First submitted
- 31 Aug 2015
- Last updated
- 1 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 15525613Rawal 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.
PubMed 9311400
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anticipated Versus Actual Patient and Caregiver Burden Following Ambulatory Orthopedic Surgery
- ClinicalTrials.gov ID
- NCT02550886
- Acronym / sponsor ID
- Work Burden / 2014-395
- Conditions
- Stress, Psychological, Pain
- Keywords
- Work Burden, Ambulatory Orthopedic Surgery, Anesthesiology, Perioperative Care
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Lost many participants to follow-up.
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Hospital for Special Surgery, New YorkUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- 10 Mar 2016 (actual)
- First posted
- 16 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient/Caregiver Dyad | – | Other: Survey |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing outpatient arthroscopic knee debridement or meniscectomy surgery at Hospital for Special Surgery
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SurveyPatients 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. | Other | Patient/Caregiver Dyad |
Primary outcome
Time taken off from work--specifically, the number of extra days taken off from work by patients and their caregivers after surgery
Time frame: 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.
2 secondary outcomes
Expected Burden of Recovery
Time frame: 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
Time frame: 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
Results and safety
The study was stopped early (reason given: Lost many participants to follow-up.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2022.
- Background: PubMed 15525613McGrath 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.
- Background: PubMed 9311400Rawal 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kanupriya Kumar, MD principal investigator
Hospital for Special Surgery, New York
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stress, Psychological and Pain, run by Hospital for Special Surgery, New York at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Lost many participants to follow-up.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time taken off from work--specifically, the number of extra days taken off from work by patients and their caregivers after surgery (time frame: 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02550886, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2022.