Clinical trial NCT04010292: Enhancing Patient Recall in Urogynecologic Surgery
Official title: Enhancing Patient Recall in Urogynecologic Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Prolapse
Incontinence
Lead sponsor: Atlantic Health System
Sponsor class: OTHER
First posted: 2019-07-08
Enrollment: 128
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: 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

Primary outcomes:
measure: Patient recall of the anticipated surgery during the preoperative visit
timeFrame: Patients will receive questionnaires within 30 days prior to their scheduled surgery.
Secondary outcomes:
measure: Patient recall of the surgery during the postoperative visit
timeFrame: Patients will receive questionnaires within 30 days of their surgery.
measure: Patient satisfaction
timeFrame: Patients will receive questionnaires within 30 days of their surgery.
Other outcomes:
Locations:
city: Morristown
country: United States
facility: Atlantic Urogynecology Associates
state: New Jersey
Study officials:
affiliation: Atlantic Health System
name: Charbel Salamon, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.