Caregiver Support and Post-operative Convalescence

Completed

• Conditions: Pelvic Organ Prolapse

• Registration Number: NCT04897061
• Lead Sponsor: Icahn School of Medicine at Mount Sinai

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.

Study Timeline

• Study First Submitted: 2021-05-18
• Study First Submitted QC: 2021-05-18
• Study First Posted: 2021-05-21
• Study Start: 2021-05-24
• Status Verified: 2022-11
• Primary Completion: 2022-11-01
• Study Completion: 2022-11-01
• Last Update Submitted: 2022-11-21
• Last Update Posted: 2022-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 103

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in Quality of Recovery 15 (QOR-15)	Post-operative day 3, 7, 14, and 28	Changes in Quality of Recovery 15 (QOR-15) scores based on a priori caregiver characteristics on post-operative days 3, 7, 14 and 28.; QOR-15 is a 15 item instrument, full score range from 0 to 150, with higher score indicating better health outcomes.
Change in Post-discharge Surgical Recovery 13 (PSR-13)	Post-operative day 3, 7, 14, and 28	Changes in Post-discharge Surgical Recovery 13 (PSR-13) scores based on a priori caregiver characteristics on post-operative days 3, 7, 14 and 28..; The PSR scale is a 13 items instrument, full score range from 0-100, with higher score indicating better recovery.

Secondary Outcome Measures

Name	Time	Method
Change in Healthcare utilization composite score	Post-operative day 3, 7, 14, and 28	Changes in a composite score comprised of healthcare utilization of phone calls, unanticipated office visits, and emergency department (ED) visits based on a priori caregiver characteristics on post-operative day 3, 7, 14, and 28.

Trial Locations

Locations (1)

Icahn School of Medicine at Mount Sinai; 🇺🇸 New York, New York, United States