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Enhancing Patient Recall in Urogynecologic Surgery

Primary Purpose

Prolapse, Incontinence

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Patient education card
Sponsored by
Atlantic Health System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Prolapse

Eligibility Criteria

19 Years - 89 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Atlantic Urogynecology AssociatesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Patient education card

Control

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
July 3, 2019
Last Updated
February 13, 2020
Sponsor
Atlantic Health System
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1. Study Identification

Unique Protocol Identification Number
NCT04010292
Brief Title
Enhancing Patient Recall in Urogynecologic Surgery
Official Title
Enhancing Patient Recall in Urogynecologic Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
November 14, 2019 (Actual)
Primary Completion Date
August 1, 2020 (Anticipated)
Study Completion Date
August 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Atlantic Health System

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prolapse, Incontinence

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
128 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patient education card
Arm Type
Experimental
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Patient education card
Intervention Description
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.
Primary Outcome Measure Information:
Title
Patient recall of the anticipated surgery during the preoperative visit
Description
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.
Time Frame
Patients will receive questionnaires within 30 days prior to their scheduled surgery.
Secondary Outcome Measure Information:
Title
Patient recall of the surgery during the postoperative visit
Description
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.
Time Frame
Patients will receive questionnaires within 30 days of their surgery.
Title
Patient satisfaction
Description
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.
Time Frame
Patients will receive questionnaires within 30 days of their surgery.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Charbel Salamon, MD, MS
Phone
9739717361
Email
charbel.salamon@atlantichealth.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charbel Salamon, MD, MS
Organizational Affiliation
Atlantic Health System
Official's Role
Principal Investigator
Facility Information:
Facility Name
Atlantic Urogynecology Associates
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07960
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Caroline Sabatino, MPH, CCRP
Phone
973-971-7361
First Name & Middle Initial & Last Name & Degree
Charbel G Salamon, MD, MS

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34534196
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.
Results Reference
derived

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Enhancing Patient Recall in Urogynecologic Surgery

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