NCT06462885

Brief Summary

The goal of this observational study is to assess the effect of living alone on total hip arthroplasty thirty-day outcomes. The main questions it aims to answer are: Is living alone associated with discharge disposition (home versus non-home)? Is living alone associated with greater incidences of secondary adverse events? Participants will be sampled from the 2021 American College of Surgeons National Surgical Quality Improvement Program

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,677

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2021

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2022

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

June 11, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 17, 2024

Completed
Last Updated

June 18, 2024

Status Verified

June 1, 2024

Enrollment Period

1.1 years

First QC Date

June 11, 2024

Last Update Submit

June 16, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Discharge disposition

    Home versus non-home

    Thirty days

Secondary Outcomes (9)

  • Requiring home services

    Thirty days

  • Functional status at discharge

    Thirty days

  • Postoperative delirium

    Thirty days

  • Hospital length of stay

    Thirty days

  • Unplanned resource utilization

    Thirty days

  • +4 more secondary outcomes

Study Arms (2)

Living alone

1,624 patients undergoing elective total hip arthroplasty who were living alone at the time of admission.

Behavioral: home support, hiving alone

Living with others

1,624 patients undergoing elective total hip arthroplasty who were living with others at the time of admission.

Behavioral: home support, living with others

Interventions

Home support: living alone

Living alone

Home support: living with others

Living with others

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Elective total hip arthroplasty patients, ACS-NSQIP 2021

You may qualify if:

  • Elective, non-emergent cases
  • Living alone
  • Living with others

You may not qualify if:

  • Fracture in surgical diagnosis
  • Hospital admission \>1 day preoperatively
  • End-stage renal disease (preoperative)
  • Metastatic disease (preoperative)
  • Sepsis (preoperative)
  • Bleeding diathesis (preoperative)
  • American Society of Anesthesiologists Physical Status Classification 5

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Zhiyi Zuo, MD, PhD

    University of Virginia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 11, 2024

First Posted

June 17, 2024

Study Start

January 1, 2021

Primary Completion

January 30, 2022

Study Completion

January 30, 2022

Last Updated

June 18, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will share

American College of Surgeons National Surgical Quality Improvement Program and the hospitals participating in the ACS NSQIP are the source of the data used herein. The Participant Use Data File (PUF) is a Health Insurance Portability and Accountability Act (HIPAA)-compliant data file containing cases submitted to the American College of Surgeons National Surgical Quality Improvement Program®. To request a copy of the PUF, individuals (data recipients) must agree to comply with the terms and conditions set forth in the Data Use Agreement, provide contact information, and complete a short online questionnaire. Once the information provided by the data recipient is received and processed by ACS NSQIP staff, a website address will be submitted electronically to the data recipient. The data recipient will then have 10 days (240 hours) to visit the website and download the data file.

Available IPD Datasets

Individual Participant Data Set Access

Locations