Evaluation of Hospital Readmission Rate Dependent on Post-Operative Follow-Up Procedure
Primary Purpose
Postoperative Complications
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Phone Call
Sponsored by
About this trial
This is an interventional prevention trial for Postoperative Complications
Eligibility Criteria
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
Sites / Locations
- The Ohio State University Wexner Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Standard of Care
Phone Call
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Post-Operative Phone Call (assess readmission rates)
Assess readmission rates
Secondary Outcome Measures
Post Discharge Survey (assess patient satisfaction)
Assess patient satisfaction
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03813537
Brief Title
Evaluation of Hospital Readmission Rate Dependent on Post-Operative Follow-Up Procedure
Official Title
Evaluation of Hospital Readmission Rate Dependent on Post-Operative Follow-Up Procedure: A Randomized Prospective Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 19, 2018 (Actual)
Primary Completion Date
June 1, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Syed Husain
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Complications
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patients will be randomized to two arms:
Intervention: post operative phone call with protocol driven follow up pathway.
Control: Current standard post operative follow up practice at our institution.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
480 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Standard of Care
Arm Type
No Intervention
Arm Description
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.
Arm Title
Phone Call
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Phone Call
Intervention Description
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.
Primary Outcome Measure Information:
Title
Post-Operative Phone Call (assess readmission rates)
Description
Assess readmission rates
Time Frame
3 days
Secondary Outcome Measure Information:
Title
Post Discharge Survey (assess patient satisfaction)
Description
Assess patient satisfaction
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kayla Diaz, BA
Phone
614-293-8549
Email
kayla.diaz@osumc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Syed Husain, MBBS
Email
syed.husain@osumc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Syed Husain, MBBS
Organizational Affiliation
OSU Wexner Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Ohio State University Wexner Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kayla Diaz, BA
Phone
614-293-8549
Email
kayla.diaz@osumc.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evaluation of Hospital Readmission Rate Dependent on Post-Operative Follow-Up Procedure
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