Testing a Decision Aid for Women With Urogenital Prolapse

Not Applicable

Completed

• Conditions: Pelvic Organ Prolapse
• Interventions: Other: decision aid developed for pelvic organ prolapse

• Registration Number: NCT03706716
• Lead Sponsor: University of Southern Denmark

Brief Summary

Development of a decision aid for women with urogenital prolapse followed by an intervention with use of the decision aid to investigate the effect on the perceived shared decision making in the clinical consultations.

A protocol for a randomized controlled non blinded multicenter trial. A feasibility trial for the protocol.

Detailed Description

Objective :

The objective is to develop a decision aid to increase successful patient involvement and increased health care professionals integration of preferences in the clinical consultations with women with urogenital prolapse.

Method:

in the context of consultations an online app solution using a multicriterial analytic approach is developed and tested in order to support shared decision making (SDM). The decision aid is developed involving four national gynecological departments through participatory design. The decision aid is tested in a randomized, controlled multicenter trial in three hospital departments in the Region of Southern Denmark. A feasibility trial for the protocol of a randomized controlled trial will decide for further approach in relations to testing the online app. in a larger scale In the randomized trial patients will either receive consultations as usual (controls) or consultations using the interface (IF) in an app. The IF is generated upon data from a patient survey regarding their preferences for treatment beforehand.

Effect measures are the perceived shared decision making within the consultation (SDM-Q-9 ) and the patientperceived satisfaction with the decision (SWD)

Study Timeline

• Study Start: 2018-06-07
• Study First Submitted: 2018-10-11
• Study First Submitted QC: 2018-10-15
• Study First Posted: 2018-10-16
• Primary Completion: 2019-03-22
• Status Verified: 2019-04
• Study Completion: 2019-04-26
• Last Update Submitted: 2019-04-30
• Last Update Posted: 2019-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 82

Inclusion Criteria

• urogenital prolaps symptoms
• e boks

Exclusion Criteria

• complicated pelvic organ prolapse which requires treatment other than dialogue, pessary, cystocele or rectocele surgery, physiotherapy or local hormones
• physical status classification system (ASA) score 3 or above
• not able to understand Danish without interpreter
• recurrent pelvic organ prolapse

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention with use of decision aid in the consultation	decision aid developed for pelvic organ prolapse	With use of developed decision aid for pelvic organ prolapse / At the beginning of the consultation the IF will be opened within the patients electronic journal. The conversation will take its starting point from the generated IF which should define the area of interest rather for the patient.

Primary Outcome Measures

Name	Time	Method
PROM of the shared decision making process	1 hour immediately after the decision on treatment was taken	Measurement of shared decision making for treatment of pelvic organ prolapse symptoms measured by questionnaire SDM-Q-9

Secondary Outcome Measures

Name	Time	Method
PROM of Satisfaction with decision	1 hour immediately after the decision on treatment was taken	Measurement of satisfaction with the decision for treatment of pelvic organ prolapse symptoms measured by questionnaire SWD

Trial Locations

Locations (3)

Hospital of Southern Jutland; 🇩🇰 Aabenraa, Denmark

Odense University Hospital; 🇩🇰 Odense, Denmark

Hospital of Lillebaelt, Kolding; 🇩🇰 Kolding, Denmark