Clinical trial NCT03925961: Role of Pre-operative Counseling in the Surgical Patient
Official title: Role of Pre-operative Counseling in the Surgical Patient
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Patient Education
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2019-04-24
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Primary outcomes:
measure: Difference in patient satisfaction as assessed by a 10-point scale
timeFrame: 1 year
Secondary outcomes:
measure: Number of cases with post operative Wound Occurrence
timeFrame: 1 year
measure: Number of post operative emergency department (ED) visits
timeFrame: 1 year
measure: Number of cases with post operative respiratory occurrences
timeFrame: 1 year
measure: Number of cases with post operative Urinary tract occurrences
timeFrame: 1 year
measure: Number of cases with post operative central nervous system (CNS) occurrences
timeFrame: 1 year
measure: Number of cases with post operative cardiac occurrences
timeFrame: 1 year
measure: Number of cases with other unclassified post operative occurrences
timeFrame: 1 year
measure: Number of cases with post operative Return to the OR within 30 days
timeFrame: 1 year
measure: Number of cases with post operative Readmission
timeFrame: 1 year
measure: Difference in time spent (in minutes) talking to patients on the phone
timeFrame: 1 year
measure: Difference in post-operative number of opioid tablets used
timeFrame: 30 days
Other outcomes:
Locations:
city: Columbia
country: United States
facility: Johns Hopkins University
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Hadley Wesson
role: PRINCIPAL_INVESTIGATOR
References: