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Completed

NCT Number: NCT04897061

Caregiver Support and Post-operative Convalescence

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Icahn School of Medicine at Mount Sinai

New York, 10128, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Change in Quality of Recovery 15 (QOR-15)

    Time frame: 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)

    Time frame: 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 outcomes

  1. Change in Healthcare utilization composite score

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Registry information

Official study title

Impact of Home Support on Quality of Post-operative Recovery After Major Pelvic Organ Prolapse Surgery

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
May 21, 2021
Registry last updated
Nov 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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