Patient Educational Video for Pelvic Organ Prolapse

May 11, 2023 updated by: Lisa Hickman, Ohio State University

Patient Educational Video to Enhance Patient Decision Satisfaction for the Treatment of Pelvic Organ Prolapse

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
37

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Ohio State University Wexner Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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.
Other: 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.
No Intervention: No video
Participants assigned to this group will not be sent the educational video to view.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Difference in SDS-PFD score
Time Frame: Within 1 day of completion of the initial visit
The difference in the score of a validated decision satisfaction questionnaire, the Satisfaction with Decision Scale for Pelvic Floor Disorders (SDS-PFD), will be compared between the two arms. A difference of 0.4 will be considered clinically meaningful. The SDS-PFD was modified from the original SDS to be specific for women making decisions regarding surgical treatment for PFD. It has 6 questions with a 5-point response scale. The score is calculated by taking the mean of the 6 answers (1-5). Higher scores correspond with higher satisfaction.
Within 1 day of completion of the initial visit

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Difference in DCS score
Time Frame: Within 1 day of completion of the initial visit
The difference in the score of the Decision Conflict Scale (DCS) will be compared between the two arms. The DCS has been validated to assess decision conflict related to treatment selection. It has 16 questions. Each question is answered on a 5-point Likert scale of 0 to 4. The scores are summed, divided by 16, and multiplied by 25. Final scores range from 0 to 100 with higher scores indicating higher decision conflict.
Within 1 day of completion of the initial visit
Difference in PIKQ-POP score
Time Frame: Within 1 day of completion of the initial visit
The difference in the Prolapse and Incontinence Knowledge - POP Questionnaire (PIKQ-POP) will be compared between the two arms. The PIKQ-POP has been validated to assess for patient knowledge of pelvic organ prolapse. It has 12 questions. Each correct question receives a score of 1. Each incorrect answer or answer of "I don't' know" receives a score of 0. The total score is the number of correct answers ranging from 0 to 12. Higher scores indicate higher POP knowledge.
Within 1 day of completion of the initial visit
Patient perception of their knowledge
Time Frame: Within 1 day of completion of the initial visit
The difference in the patient's perception of their knowledge will be compared between the two arms. Patients will be asked their perception of their level of knowledge of pelvic organ prolapse.
Within 1 day of completion of the initial visit
Physician's perception of patient's understanding of prolapse
Time Frame: Within 1 day of completion of the initial visit
The difference in the physician's perception of the patient's understanding of prolapse will be compared between the two arms. The physician will complete a counseling survey with a set of non-validated questions to assess their perception of if the patient viewed the video, the ease of counseling, and if the patient had a good understanding of their clinical issue.
Within 1 day of completion of the initial visit
Difference in SDS-PFD scores after management of prolapse
Time Frame: Within 2 weeks to 1 year after undergoing the chosen management option
Patients will complete a final survey, the post-management survey. The difference in the patient's SDS-PFD scores will be compared between the two arms. The post-management survey will be administered in follow up to the patient after undergoing their chosen management option for the treatment of prolapse. Higher SDS-PDF scores correspond with higher satisfaction.
Within 2 weeks to 1 year after undergoing the chosen management option
Difference in PIKQ-POP scores after management of prolapse
Time Frame: Within 2 weeks to 1 year after undergoing the chosen management option
Patients will complete a final survey, the post-management survey. The difference in the patient's PIKQ-POP scores will be compared between the two arms. The post-management survey will be administered in follow up to the patient after undergoing their chosen management option for the treatment of prolapse. Higher PIKQ-POP scores indicate higher POP knowledge.
Within 2 weeks to 1 year after undergoing the chosen management option

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ohio State University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 2, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 17, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 12, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 13, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 30, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 9, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 12, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 11, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2021H0064

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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