Evaluation of Hospital Readmission Rate Dependent on Post-Operative Follow-Up Procedure

Evaluation of Hospital Readmission Rate Dependent on Post-Operative Follow-Up Procedure: A Randomized Prospective Clinical Trial

This study is a randomized clinical trial among colorectal surgery patients that will compare the efficacy of two different discharge protocols - current standard of care follow-up at two weeks post-op versus a 3-day phone call intervention. The overall aim of the study is to identify areas of improvement for discharging and following patients within 30 days of colorectal surgery.

Study Overview

• Status: Recruiting
• Conditions: Postoperative Complications
• Intervention / Treatment: Other: Phone Call

Detailed Description

This study will be a prospective clinical trial, in which colorectal surgery patients will be randomly assigned to a control or experimental group. Patients will be consented and randomized prior to discharge.The control group will be discharged with standard of care follow-up instructions described by The Ohio State University Wexner Medical Center (OSUWMC), and scheduled to come in for a standard follow-up clinic visit within 2-3 weeks. The experimental group will also be scheduled for a 2-3 week post-op follow-up appointment, but will also receive a phone call 3-days post procedure. During this phone call, the patient will be asked questions using a study-specific questionnaire that is based on the most frequent indications for readmission after colorectal surgery. Based on the responses, patients will be advised to maintain the scheduled 2-3 week post-op appointment, visit the clinic within 48 hours, or go to the Emergency Department immediately. To determine if patients had visited an ED or been readmitted to a hospital within 30 days of colorectal surgery, both the standard of care and intervention groups will receive a phone call 30-days post-discharge. At this time we will also conduct the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) survey to measure patient satisfaction.

• Study Type: Interventional
• Enrollment (Estimated): 480
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kayla Diaz, BA; Phone Number: 614-293-8549; Email: kayla.diaz@osumc.edu
• Study Contact Backup: Name: Syed Husain, MBBS; Email: syed.husain@osumc.edu

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Recruiting
      • The Ohio State University Wexner Medical Center
      • Contact: Kayla Diaz, BA; Phone Number: 614-293-8549; Email: kayla.diaz@osumc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age greater than 18 years old
• Patients who underwent colorectal surgery at The Ohio State University Wexner Medical Center

Exclusion Criteria:

• Patients under 18 years old
• Patients with limited ability to communicate
• Patients who do not have a telephone

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard of Care; The control will be discharged with standard of care follow-up instructions and scheduled for a standard follow-up clinic visit within 2-3 weeks post-op.
Experimental: Phone Call; The experimental group will receive a phone call intervention 3 days post-op. During this phone call, the patient will be asked questions using a study questionnaire based on the most frequent indications for readmission post colorectal surgery. Based on the responses, patients will be advised to maintain the scheduled appointment, visit the clinic within 48 hours, or go to the Emergency Department immediately.	Other: Phone Call; The experimental group will receive a phone call 3-days post procedure and asked questions based on the most frequent indications for readmission after colorectal surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-Operative Phone Call (assess readmission rates)	Assess readmission rates	3 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post Discharge Survey (assess patient satisfaction)	Assess patient satisfaction	30 days

Collaborators and Investigators

• Sponsor: Syed Husain
• Investigators: Principal Investigator: Syed Husain, MBBS, OSU Wexner Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): June 19, 2018
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: May 24, 2018
• First Submitted That Met QC Criteria: January 22, 2019
• First Posted (Actual): January 23, 2019

Study Record Updates

• Last Update Posted (Actual): October 25, 2023
• Last Update Submitted That Met QC Criteria: October 23, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications
• Other Study ID Numbers: 2018H0207

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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