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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03813537
Other study ID # 2018H0207
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 19, 2018
Est. completion date December 31, 2024

Study information

Verified date October 2023
Source Ohio State University
Contact Kayla Diaz, BA
Phone 614-293-8549
Email kayla.diaz@osumc.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 480
Est. completion date December 31, 2024
Est. primary completion date June 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States The Ohio State University Wexner Medical Center Columbus Ohio

Sponsors (1)

Lead Sponsor Collaborator
Syed Husain

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Post-Operative Phone Call (assess readmission rates) Assess readmission rates 3 days
Secondary Post Discharge Survey (assess patient satisfaction) Assess patient satisfaction 30 days
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