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Clinical Trials/NCT03925961
NCT03925961
Terminated
Not Applicable

Role of Pre-operative Counseling in the Surgical Patient

Johns Hopkins University1 site in 1 country6 target enrollmentAugust 6, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Patient Education
Sponsor
Johns Hopkins University
Enrollment
6
Locations
1
Primary Endpoint
Difference in patient satisfaction as assessed by a 10-point scale
Status
Terminated
Last Updated
4 years ago

Overview

Brief Summary

The study will seek to determine if surgical patients do better or the same if participants undergo pre-operative counseling for elective laparoscopic same day surgery. The study hypothesizes that patients who receive a pre-operative education booklet and a phone call from a surgical registered nurse, compared to the current standard of care, will have higher satisfaction with regard to participants' surgical experience, decrease in the number of post-operative phone calls, decrease in the number of opioid medications, and decrease in the number of emergency department visits. The importance of this study is to understand what surgical clinical practices can do in the pre-operative setting to enhance a surgical patient's recovery.

Detailed Description

In the last decade there has been an increasing focus on the patient's pre-operative, operative and post operative experience to help patient's in participants' recovery. For example, the surgical community has focused on pathways such as Enhanced Recovery After Surgery (ERAS), to improve patient's outcome and surgical experience. Despite this emphasis, little has been described in the literature as to how surgeons can improve a patient's experience by counseling participants on what participants can expect before, during, and after the surgery.

Registry
clinicaltrials.gov
Start Date
August 6, 2019
End Date
September 25, 2020
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • General surgical patients who will undergo same-day laparoscopic ventral hernia, inguinal hernia, and gallbladder surgery at Howard County General Hospital with the general surgery practice at Johns Hopkins Community Physicians.

Exclusion Criteria

  • Patients less than 18 years of age
  • Adults who lack the capacity to consent
  • Pregnant women
  • Prisoners
  • Non-English speakers.

Outcomes

Primary Outcomes

Difference in patient satisfaction as assessed by a 10-point scale

Time Frame: 1 year

The study will compare patient satisfaction scores between the three arms of the study groups to determine if there is a difference in patient satisfaction. It will be based on a scale of 1 to 10, 10 being the most satisfied and 1 being the least.

Secondary Outcomes

  • Number of cases with post operative respiratory occurrences(1 year)
  • Number of post operative emergency department (ED) visits(1 year)
  • Number of cases with post operative Return to the OR within 30 days(1 year)
  • Number of cases with post operative Readmission(1 year)
  • Difference in post-operative number of opioid tablets used(30 days)
  • Number of cases with post operative Urinary tract occurrences(1 year)
  • Number of cases with post operative cardiac occurrences(1 year)
  • Number of cases with other unclassified post operative occurrences(1 year)
  • Difference in time spent (in minutes) talking to patients on the phone(1 year)
  • Number of cases with post operative central nervous system (CNS) occurrences(1 year)
  • Number of cases with post operative Wound Occurrence(1 year)

Study Sites (1)

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