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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/21/2021.

Role of Pre-operative Counseling in the Surgical Patient

Clinicaltrials.gov identifier NCT03925961

Recruitment Status Recruiting

First Posted April 24, 2019

Last update posted September 17, 2020

Study Description

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.

  • Condition or Disease:Patient Education
  • Intervention/Treatment: Other: Preoperative education
  • Phase: N/A
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.

Study Design
  • Study Type: Interventional
  • Estimated Enrollment: 90 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Double (Participant, Care Provider)
  • Primary Purpose: Health Services Research
  • Official Title: Role of Pre-operative Counseling in the Surgical Patient
  • Actual Study Start Date: August 2019
  • Estimated Primary Completion Date: August 2021
  • Estimated Study Completion Date: August 2021
Arms and interventions
Arm Intervention/treatment
Experimental: 'education booklet and preoperative' arm
All subjects in the 'education booklet and preoperative' arm will receive the current standard Johns Hopkins Community Physicians Surgery packet and the Patient Information Booklet, specific to participants' surgery. Those subjects randomized to the 'education booklet and preoperative' arm will receive a pre-operative phone call by the research study's lead nurse, Catherine Davidson, approximately 1 week after participants enroll in the study. She will review pre-operative and post-operative guidelines pertinent to participants' operative as outlined in the patient information booklet. The amount of time (in minutes) that this phone call takes will be recorded in an excel file sheet.
Other: Preoperative education
The intervention is focused around providing patients with educational information in the pre-operative setting and determine if this improves patients' surgical experience.
Experimental: 'education booklet' arm
All subjects in the 'education booklet' arm will receive the current standard Johns Hopkins Community Physicians Surgery packet and the Patient Information Booklet, specific to participants' surgery
Other: Preoperative education
The intervention is focused around providing patients with educational information in the pre-operative setting and determine if this improves patients' surgical experience.
Outcome Measures
  • Primary Outcome Measures: 1. 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 Outcome Measures: 1. Number of cases with post operative Wound Occurrence [ Time Frame: 1 year ]
  • 2. Number of post operative emergency department (ED) visits [ Time Frame: 1 year ]
  • 3. Number of cases with post operative respiratory occurrences [ Time Frame: 1 year ]
  • 4. Number of cases with post operative Urinary tract occurrences [ Time Frame: 1 year ]
  • 5. Number of cases with post operative central nervous system (CNS) occurrences [ Time Frame: 1 year ]
  • 6. Number of cases with post operative cardiac occurrences [ Time Frame: 1 year ]
  • 7. Number of cases with other unclassified post operative occurrences [ Time Frame: 1 year ]
  • 8. Number of cases with post operative Return to the OR within 30 days [ Time Frame: 1 year ]
  • 9. Number of cases with post operative Readmission [ Time Frame: 1 year ]
  • 10. Difference in time spent (in minutes) talking to patients on the phone [ Time Frame: 1 year ]
    The study will assess if there is a difference in the amount of total time spent talking to patients over the phone.
  • 11. Difference in post-operative number of opioid tablets used [ Time Frame: 30 days ]
    The study will assess if there is a difference in the number of opioid tablets used at post operative day 30. For the purposes of this study, study patients will be discharged home with a prescription for oxycodone 5mg.
Eligibility Criteria
  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
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.

Contacts and Locations
Contacts

Contact: Hadley Wesson 410-730-1988 hwesson1@jhu.edu

Locations

United States, Maryland
Johns Hopkins University
Columbia

Sponsors and Collaborators

Johns Hopkins University

Investigators

Principal Investigator: Hadley Wesson Johns Hopkins University

More Information
  • Responsible Party: Johns Hopkins University
  • ClinicalTrials.gov Identifier: NCT03925961 History of Changes
  • Other Study ID Numbers: IRB00161974
  • First Posted: April 24, 2019 Key Record Dates
  • Last Update Posted: September 17, 2020
  • Last Verified: September 2020
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: No
  • Plan Description: The Investigators will not make the individual participant data (IPD) available to other researchers.
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No