Clinical trial NCT04996563: Patient Educational Video for Pelvic Organ Prolapse
Official title: Patient Educational Video to Enhance Patient Decision Satisfaction for the Treatment of Pelvic Organ Prolapse
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pelvic Organ Prolapse
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2021-08-09
Enrollment: 37
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are randomly assigned prospectively to one of two interventions to evaluate the effect of the educational video intervention on their knowledge of prolapse and satisfaction in their healthcare decision making for management of prolapse.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Difference in SDS-PFD score
timeFrame: Within 1 day of completion of the initial visit
Secondary outcomes:
measure: Difference in DCS score
timeFrame: Within 1 day of completion of the initial visit
measure: Difference in PIKQ-POP score
timeFrame: Within 1 day of completion of the initial visit
measure: Patient perception of their knowledge
timeFrame: Within 1 day of completion of the initial visit
measure: Physician's perception of patient's understanding of prolapse
timeFrame: Within 1 day of completion of the initial visit
measure: Difference in SDS-PFD scores after management of prolapse
timeFrame: Within 2 weeks to 1 year after undergoing the chosen management option
measure: Difference in PIKQ-POP scores after management of prolapse
timeFrame: Within 2 weeks to 1 year after undergoing the chosen management option
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Ohio State University Wexner Medical Center
state: Ohio
Study officials:
References: