NCT03813537

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
481

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2018

Longer than P75 for not_applicable

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 24, 2018

Completed
26 days until next milestone

Study Start

First participant enrolled

June 19, 2018

Completed
7 months until next milestone

First Posted

Study publicly available on registry

January 23, 2019

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2024

Completed
Last Updated

July 17, 2024

Status Verified

July 1, 2024

Enrollment Period

6 years

First QC Date

May 24, 2018

Last Update Submit

July 15, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Post-Operative Phone Call (assess readmission rates)

    Assess readmission rates

    3 days

Secondary Outcomes (1)

  • Post Discharge Survey (assess patient satisfaction)

    30 days

Study Arms (2)

Standard of Care

NO INTERVENTION

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.

Phone Call

EXPERIMENTAL

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

Interventions

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.

Phone Call

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Syed Husain, MBBS

    OSU Wexner Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Patients will be randomized to two arms: 1. Intervention: post operative phone call with protocol driven follow up pathway. 2. Control: Current standard post operative follow up practice at our institution.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor - Colon and Rectal Surgery

Study Record Dates

First Submitted

May 24, 2018

First Posted

January 23, 2019

Study Start

June 19, 2018

Primary Completion

June 1, 2024

Study Completion

July 15, 2024

Last Updated

July 17, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations