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Enhancing Patient Recall in Urogynecologic Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04010292
Recruitment Status : Recruiting
First Posted : July 8, 2019
Last Update Posted : February 17, 2020
Information provided by (Responsible Party):
charbel salamon, Atlantic Health System

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Prolapse Incontinence Behavioral: Patient education card Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 128 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Enhancing Patient Recall in Urogynecologic Surgery
Actual Study Start Date : November 14, 2019
Estimated Primary Completion Date : August 1, 2020
Estimated Study Completion Date : August 1, 2020

Arm Intervention/treatment
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.

No Intervention: Control

Primary Outcome Measures :
  1. Patient recall of the anticipated surgery during the preoperative visit [ Time Frame: Patients will receive questionnaires within 30 days prior to their scheduled surgery. ]

    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.

Secondary Outcome Measures :
  1. Patient recall of the surgery during the postoperative visit [ Time Frame: Patients will receive questionnaires within 30 days of their surgery. ]

    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.

  2. Patient satisfaction [ Time Frame: Patients will receive questionnaires within 30 days of their surgery. ]
    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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   19 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04010292

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Contact: Charbel Salamon, MD, MS 9739717361

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United States, New Jersey
Atlantic Urogynecology Associates Recruiting
Morristown, New Jersey, United States, 07960
Contact: Caroline Sabatino, MPH, CCRP    973-971-7361      
Principal Investigator: Charbel G Salamon, MD, MS         
Sponsors and Collaborators
Atlantic Health System
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Principal Investigator: Charbel Salamon, MD, MS Atlantic Health System
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Responsible Party: charbel salamon, PI/Medical Director of Urogynecology, Atlantic Health System Identifier: NCT04010292    
Other Study ID Numbers: 1448021-1
First Posted: July 8, 2019    Key Record Dates
Last Update Posted: February 17, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pathological Conditions, Anatomical