Enhancing Patient Recall in Urogynecologic Surgery

Patient counseling is an essential part of any new treatment implementation. This process becomes even more important when it involves surgical counseling. This is when the patient and the surgeon discuss the possible surgical options and ideally establish a plan for the appropriate surgical intervention. Unfortunately, multiple studies have shown that patients tend to have poor recall of the key elements discussed during the consultation (1-3). In the investigators' experience, the concern lies specifically in the level of recall that patients have regarding their planned surgical procedure, as most patients cannot correctly state the planned intervention despite extensive counseling and explanation. Lack of knowledge about the type of surgery can have serious implications for the patient in the future. For example, knowing facts like the presence or absence of the cervix and whether future pap smears are needed or the presence of an implant, such as a mesh are necessary for the patient's well-being and proper medical care down the line, especially when the patient has multiple medical providers. In addition, previous research has demonstrated that low-quality counseling and the feeling of being "unprepared for surgery" directly correlate with patient dissatisfaction (4). This is especially relevant in the field of female pelvic reconstructive surgery, where the success of surgical interventions relies heavily upon subjective patient-reported outcomes (5).

There have been many studies to augment the counseling process using supplemental materials. These have included use of multiple visual charts, anatomical models, and passive and interactive audiovisual aids (6). Some improvement in the outcomes has been observed in various fields of medicine with the dissemination of supplemental patient resources (7-10). However, in urogynecology, the effectiveness of surgical counseling sessions has not been achieved despite the different additional methods for patient education (6, 11). Reasons that urogynecologic supplemental materials have not seen the same level of success as those in other fields of medicine include the complexity of the surgeries and the language used in many of these educational aids (12). The investigators aim to address the problem of poor patient recall of their procedure by providing them with an easy-to-read patient card detailing the anticipated surgery at the time of their consult.

Study Overview

• Status: Unknown
• Conditions: Prolapse; Incontinence
• Intervention / Treatment: Behavioral: Patient education card

• Study Type: Interventional
• Enrollment (Anticipated): 128
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Morristown, New Jersey, United States, 07960
      • Recruiting
      • Atlantic Urogynecology Associates
      • Contact: Caroline Sabatino, MPH, CCRP; Phone Number: 973-971-7361
      • Principal Investigator: Charbel G Salamon, MD, MS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• English-speaking females, ages >18 and <90 years, present for surgical planning for reconstructive urogynecologic procedures

Exclusion Criteria:

• Dementia, blindness, non-English speakers

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control
Experimental: Patient education card	Behavioral: Patient education card; Patient who are randomized to receive a patient card at the end of the counseling visit will be able to take an index-card sized card with them which will highlight their anticipated surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient recall of the anticipated surgery during the preoperative visit	All patient present for a preoperative visit, which occurs within 30 days of the scheduled surgery. At this time, all patients will receive a questionnaire testing their knowledge about their upcoming surgery. We will compare the answers from patients who received the education card and those who did not at the time of their surgical counseling visit. The name of the questionnaire is "The 7-Question Knowledge Questionnaire," which was developed by the Urogynecology Department at Atlantic Health System. The scale consists of 7 questions and will have score ranges between from 0 to 7.	Patients will receive questionnaires within 30 days prior to their scheduled surgery.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient recall of the surgery during the postoperative visit	All patients will receive questionnaires, testing their knowledge of the performed surgery, during their postoperative follow-up visit. The questionnaire will include "The 7-Question Knowledge Questionnaire," which was developed by the Urogynecology Department at Atlantic Health System. The scale consists of 7 questions and will have score ranges between from 0 to 7.	Patients will receive questionnaires within 30 days of their surgery.
Patient satisfaction	A validated questionnaire, called the "Leiden Perioperative care Patient Satisfaction questionnaire" will be given at the postoperative visit to determine patient satisfaction. A part of this questionnaire will be used, which consists of 4 questions. The total score will range between 0 and 4.	Patients will receive questionnaires within 30 days of their surgery.

Collaborators and Investigators

• Sponsor: Atlantic Health System
• Investigators: Principal Investigator: Charbel Salamon, MD, MS, Atlantic Health System

Publications and helpful links

General Publications

• Chernyak S, Caraballo R, Chiu S, Salamon C. Improving Patient Recall of Planned Intervention After Surgical Counseling: The IRIS Randomized Controlled Trial. Female Pelvic Med Reconstr Surg. 2022 May 1;28(5):280-286. doi: 10.1097/SPV.0000000000001102. Epub 2021 Sep 15.

Study record dates

Study Major Dates

• Study Start (Actual): November 14, 2019
• Primary Completion (Anticipated): August 1, 2020
• Study Completion (Anticipated): August 1, 2020

Study Registration Dates

• First Submitted: July 3, 2019
• First Submitted That Met QC Criteria: July 3, 2019
• First Posted (Actual): July 8, 2019

Study Record Updates

• Last Update Posted (Actual): February 17, 2020
• Last Update Submitted That Met QC Criteria: February 13, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Prolapse
• Other Study ID Numbers: 1448021-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No