Enhancing Patient Recall in Urogynecologic Surgery

NCT ID: NCT04010292

Last Updated: 2020-02-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 128 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-14
• Study Completion Date: 2020-08-01

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.

Conditions

Prolapse; Incontinence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Patient education card

Group Type: EXPERIMENTAL

Patient education card

Intervention Type: BEHAVIORAL

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.

Control

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Atlantic Health System

OTHER

Sponsor Role: lead

Responsible Party

charbel salamon

PI/Medical Director of Urogynecology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Charbel Salamon, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Atlantic Health System

Locations

Atlantic Urogynecology Associates

Morristown, New Jersey, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Charbel Salamon, MD, MS

Role: CONTACT

charbel.salamon@atlantichealth.org

9739717361

Facility Contacts

Caroline Sabatino, MPH, CCRP

Role: primary

973-971-7361

References

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.

Reference Type: DERIVED

PMID: 34534196 (View on PubMed)

Other Identifiers

1448021-1

Identifier Type: -

Identifier Source: org_study_id