Role of Pre-operative Counseling in the Surgical Patient

NCT ID: NCT03925961

Last Updated: 2021-10-20

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-06
• Study Completion Date: 2020-09-25

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.

Conditions

Patient Education

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: DOUBLE

Study Groups

control arm

All subjects in the control arm will receive the current preoperative and post operative instructions.

Group Type: NO_INTERVENTION

No interventions assigned to this group

'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

Group Type: EXPERIMENTAL

Preoperative education

Intervention Type: OTHER

The intervention is focused around providing patients with educational information in the pre-operative setting and determine if this improves patients' surgical experience.

'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.

Group Type: EXPERIMENTAL

Preoperative education

Intervention Type: OTHER

The intervention is focused around providing patients with educational information in the pre-operative setting and determine if this improves patients' surgical experience.

Interventions

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hadley Wesson

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Johns Hopkins University

Columbia, Maryland, United States

Countries

United States

Other Identifiers

IRB00161974

Identifier Type: -

Identifier Source: org_study_id