Patient Educational Video for Pelvic Organ Prolapse

NCT ID: NCT04996563

Last Updated: 2023-05-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-02
• Study Completion Date: 2022-12-12

Brief Summary

This is a single-blinded, randomized controlled trial investigating if a patient educational video on pelvic organ prolapse improves patient understanding of this pelvic floor disorder and satisfaction in their healthcare decision making for its management.

Detailed Description

This is a randomized controlled trial. Participants will be randomized either to watch a pre-visit educational video on pelvic organ prolapse (POP) in addition to routine physician counseling (intervention group) or routine physician counseling alone (control group). The counseling physician will be blinded. All participants will complete a pre-visit survey that includes the Prolapse and Incontinence Knowledge - POP (PIKQ-POP) and a demographics questionnaire. The PIKQ-POP has been validated to assess for patient knowledge of POP. Those randomized to the intervention group will take a brief survey after watching the video asking if they had any technical issues with the video and confirming they watched the video. At the end of all initial clinic visits, participants will complete a post-visit survey that includes the validated Satisfaction with Decision Scale for Pelvic Floor Disorders (SDS-PFD) to assess the primary outcome of change in patient decision satisfaction. The SDS is designed to assess satisfaction with a treatment decision. The SDS was modified into the SDS-PFD to be specific for women making decisions regarding surgical treatment for pelvic floor disorders. To assess the secondary outcomes of change in decision conflict and POP knowledge, the post-visit survey will also include a validated Decision Conflict Scale (DCS) and the PIKQ-POP. The DCS was developed to evaluate the effect of health care decision aids and decision-supporting interventions on decision uncertainty. The physician will also complete a counseling survey at the end of the visit to assess their perception of patient comprehension and their ease of counseling. After undergoing their chosen management option, participants will also complete a post-management survey in follow up which will include the SDS-PFD and PIKQ-POP.

Conditions

Pelvic Organ Prolapse

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Video

A brief educational video on POP will be sent electronically to participants randomized to the video group. Participants will view the video within one week prior to their consultation visit.

Group Type: EXPERIMENTAL

Video

Intervention Type: OTHER

A brief educational video, approximately 9 minutes in duration, on pelvic organ prolapse is sent electronically to patients to view prior to their initial visit in order to provide early access to information. The video was created to educate patients on the following key components of prolapse: the clinical condition, associated symptoms, common risk factors, evaluation and diagnosis, non-surgical treatment options, and surgical treatment options. Simple drawings and animations are included as visual aids to enhance the ability to conceptualize prolapse and its management options.

No video

Participants assigned to this group will not be sent the educational video to view.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Video

A brief educational video, approximately 9 minutes in duration, on pelvic organ prolapse is sent electronically to patients to view prior to their initial visit in order to provide early access to information. The video was created to educate patients on the following key components of prolapse: the clinical condition, associated symptoms, common risk factors, evaluation and diagnosis, non-surgical treatment options, and surgical treatment options. Simple drawings and animations are included as visual aids to enhance the ability to conceptualize prolapse and its management options.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Initial evaluation for symptomatic POP
• Age greater than or equal to 18 years old
• Reliable access to text or e-mail

Exclusion Criteria

• Pregnant women
• Presence of cognitive disability
• Non-English speaking patient or requiring interpreter assistance
• Women with a history of prior pelvic organ prolapse therapy, i.e. pelvic floor physical therapy, pessary, or surgical repair

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Ohio State University

OTHER

Sponsor Role: lead

Responsible Party

Lisa Hickman

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ohio State University Wexner Medical Center

Columbus, Ohio, United States

Countries

United States

Other Identifiers

2021H0064

Identifier Type: -

Identifier Source: org_study_id