Viewing Study NCT04010292


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Study NCT ID: NCT04010292
Status: UNKNOWN
Last Update Posted: 2020-02-17
First Post: 2019-07-03
Is Possible Gene Therapy: False
Has Adverse Events: False

Brief Title: Enhancing Patient Recall in Urogynecologic Surgery
Sponsor: Atlantic Health System
Organization:

Study Overview

Official Title: Enhancing Patient Recall in Urogynecologic Surgery
Status: UNKNOWN
Status Verified Date: 2020-02
Last Known Status: RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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.
Detailed Description: None

Study Oversight

Has Oversight DMC: False
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: