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Caregiver Support and Post-operative Convalescence

Sponsor
Icahn School of Medicine at Mount Sinai (Other)
Overall Status
Recruiting
CT.gov ID
NCT04897061
Collaborator
(none)
120
Enrollment
1
Location
15.3
Anticipated Duration (Months)
7.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    120 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Impact of Home Support on Quality of Post-operative Recovery After Major Pelvic Organ Prolapse Surgery
    Actual Study Start Date :
    May 24, 2021
    Anticipated Primary Completion Date :
    Sep 1, 2022
    Anticipated Study Completion Date :
    Sep 1, 2022

    Arms and Interventions

    Arm Intervention/Treatment
    Participants undergoing major pelvic organ prolapse surgery

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    2. 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

    1. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Icahn School of Medicine at Mount Sinai New York New York United States 10128

    Sponsors and Collaborators

    • Icahn School of Medicine at Mount Sinai

    Investigators

    • Principal Investigator: Ann Tran, MD, Icahn School of Medicine at Mount Sinai

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Ann Tran, MD, Assistant Professor, Icahn School of Medicine at Mount Sinai
    ClinicalTrials.gov Identifier:
    NCT04897061
    Other Study ID Numbers:
    • IRB 20-01766
    First Posted:
    May 21, 2021
    Last Update Posted:
    Mar 23, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Ann Tran, MD, Assistant Professor, Icahn School of Medicine at Mount Sinai
    Prolapse
    Same day discharge
    Caregiver
    Additional relevant MeSH terms:
    Prolapse
    Pelvic Organ Prolapse

    Study Results

    No Results Posted as of Mar 23, 2022