Clinical trial NCT04897061: Caregiver Support and Post-operative Convalescence
Official title: Impact of Home Support on Quality of Post-operative Recovery After Major Pelvic Organ Prolapse Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pelvic Organ Prolapse
Keywords: Prolapse
Same day discharge
Caregiver
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2021-05-21
Enrollment: 103
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women age 18 years or older undergoing major pelvic organ prolapse surgery (vaginal apical suspension, laparoscopic or robotic apical suspension, obliterative procedure) or minor prolapse or incontinence procedure with concomitant hysterectomy.

Brief summary: This is a prospective cohort study designed to investigate the impact of home caregiver support on post-operative convalescence in patients undergoing same day discharge after major urogynecologic surgery. Questionnaires assessing post-operative convalescence will be distributed at several time points after surgery. The main hypothesis is that increased caregiver support in the post-operative period will improve post-operative convalescence of patients undergoing major urogynecologic surgery.

Detailed description: Pelvic organ prolapse and incontinence surgery is now often done on an outpatient basis (also known as same day discharge surgery or SDD). While there are data to support the safety of this practice, little is known about the burden and demands of this practice on the patient and her support system/caregivers. Furthermore, there are no guidelines on requirements for assistance at home or what impact home caregiver support has on recovery. The study team is interested in investigating the spectrum of support that patients have at home in terms of caregivers such as family, friends, neighbors and how that may impact their recovery. The intervention for this study will be comprised of administering post-operative questionnaires that assess patients' post-operative convalescence and quantify the required or available caregiver support. The clinical outcome of interest is recovery as assessed by the validated questionnaires.

Eligibility criteria: Inclusion Criteria:

* Age 18 years or older
* English speaking
* Successfully discharged on the day of surgery

Exclusion Criteria:

* Discharge to a nursing home, assisted living or rehabilitation facility.
* Dementia or altered mental status that would make recall of recovery process unreliable.
* Inability to access Internet or phone for study participation

Primary outcomes:
measure: Change in Quality of Recovery 15 (QOR-15)
timeFrame: Post-operative day 3, 7, 14, and 28
measure: Change in Post-discharge Surgical Recovery 13 (PSR-13)
timeFrame: Post-operative day 3, 7, 14, and 28
Secondary outcomes:
measure: Change in Healthcare utilization composite score
timeFrame: Post-operative day 3, 7, 14, and 28
Other outcomes:
Locations:
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Ann Tran, MD
role: PRINCIPAL_INVESTIGATOR
References:
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