Role of Pre-operative Counseling in the Surgical Patient

Patient Education Clinical Trial

Official title:

Role of Pre-operative Counseling in the Surgical Patient

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03925961
• Other study ID #: IRB00161974
• Status: Terminated
• Phase: N/A
• Start date: August 6, 2019
• Est. completion date: September 25, 2020

Study information

• Verified date: September 2020
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: September 25, 2020
• Est. primary completion date: September 25, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Patient Education

Intervention

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.

Locations

Country	Name	City	State
United States	Johns Hopkins University	Columbia	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in patient satisfaction as assessed by a 10-point scale	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.	1 year
Secondary	Number of cases with post operative Wound Occurrence		1 year
Secondary	Number of post operative emergency department (ED) visits		1 year
Secondary	Number of cases with post operative respiratory occurrences		1 year
Secondary	Number of cases with post operative Urinary tract occurrences		1 year
Secondary	Number of cases with post operative central nervous system (CNS) occurrences		1 year
Secondary	Number of cases with post operative cardiac occurrences		1 year
Secondary	Number of cases with other unclassified post operative occurrences		1 year
Secondary	Number of cases with post operative Return to the OR within 30 days		1 year
Secondary	Number of cases with post operative Readmission		1 year
Secondary	Difference in time spent (in minutes) talking to patients on the phone	The study will assess if there is a difference in the amount of total time spent talking to patients over the phone.	1 year
Secondary	Difference in post-operative number of opioid tablets used	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.	30 days