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Role of Pre-operative Counseling in the Surgical Patient

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ClinicalTrials.gov Identifier: NCT03925961
Recruitment Status : Recruiting
First Posted : April 24, 2019
Last Update Posted : August 9, 2019
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

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 Intervention/treatment Phase
Patient Education Other: Preoperative education Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
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 6, 2019
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : August 2021

Arm Intervention/treatment
No Intervention: control arm
All subjects in the control arm will receive the current preoperative and post operative instructions.
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.

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.




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.



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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03925961


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

Locations
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United States, Maryland
Johns Hopkins University Recruiting
Columbia, Maryland, United States, 21045
Contact: Hadley Wesson         
Sponsors and Collaborators
Johns Hopkins University
Investigators
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Principal Investigator: Hadley Wesson Johns Hopkins University

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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: August 9, 2019
Last Verified: August 2019
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No