A Standardized Bundle Protocol to Optimize Outcomes With Patients Undergoing Gynecological Surgery

Difference in outcome measures with the addition of post-operative evidence based bundle pre-operative education compared to standard pre-operative education given to patients prior to hysterectomy.

Study Overview

• Status: Completed
• Conditions: Hysterectomy

Detailed Description

The purpose of this project is to evaluate whether there is a difference in outcome measures (length of stay, occurrence of readmission, and patient satisfaction) with the addition of a post-operative evidence-based bundle/standard pre-operative education compared to standard pre-operative education alone that is given to patients prior to a hysterectomy (open, vaginal, or laparoscopic).

• Study Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85255
      • HonorHealth Scottsdale Thompson Peak

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Patients who are admitted for all hysterectomies from October 1, 2017 through December 31, 2017, who speak English, and who are discharged home.

Description

Inclusion Criteria:

• Patients who are admitted for all hysterectomies from October 1, 2017 through December 31, 2017, who speak English, and who are discharged home.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Post-op evidence based bundle w/ Pre-op education; 25 patients undergoing hysterectomy from October 1, 2017 to December 31, 2017 will receive the post-operative evidence based bundle/standard pre-operative education.
Standard pre-operative education alone; 25 patients undergoing hysterectomy from October 1, 2017 to December 31, 2017 will receive the standard pre-operative education alone.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of Stay	Number of days spent in the hospital from the first post-operative day to the day of discharge	0 to 30 days
Occurrence of Re-Admission	Re-admission within 30 days will be measured through the EMR	0 to 30 days
Patient Satisfaction	Patient Satisfaction Survey that consists of 7 questions utilizing a likert scale from excellent to poor	0 to 30 days

Collaborators and Investigators

• Sponsor: HonorHealth Research Institute

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 17, 2017
• Primary Completion (ACTUAL): January 19, 2018
• Study Completion (ACTUAL): February 28, 2018

Study Registration Dates

• First Submitted: July 26, 2018
• First Submitted That Met QC Criteria: July 26, 2018
• First Posted (ACTUAL): August 1, 2018

Study Record Updates

• Last Update Posted (ACTUAL): August 1, 2018
• Last Update Submitted That Met QC Criteria: July 26, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: 1088437

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No