Role of Pre-operative Counseling in the Surgical Patient

NCT03925961 | Terminated

• 1 other identifier: IRB00161974
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Patient Education

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Number of cases with post operative Wound Occurrence

  1 year

• Number of post operative emergency department (ED) visits

  1 year

• Number of cases with post operative respiratory occurrences

  1 year

• Number of cases with post operative Urinary tract occurrences

  1 year

• Number of cases with post operative central nervous system (CNS) occurrences

  1 year

Study Arms (3)

control arm

NO INTERVENTION

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

'education booklet' arm

EXPERIMENTAL

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

'education booklet and preoperative' arm

EXPERIMENTAL

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

Interventions

Preoperative education 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; 'education booklet' arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients less than 18 years of age
• Adults who lack the capacity to consent
• Pregnant women
• Prisoners
• Non-English speakers.

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins University

Columbia, Maryland, 21045, United States

Location

Study Officials

• Hadley Wesson

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2019
• First Posted: April 24, 2019
• Study Start: August 6, 2019
• Primary Completion: September 25, 2020
• Study Completion: September 25, 2020
• Last Updated: October 20, 2021

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)