NCT03706716

Testing a Decision Aid for Women With Urogenital Prolapse

Support Women's Decision Making - the Effect of Using an Online App in the Clinical Consultations of Patients With Urogenital Prolapse. A Protocol for a Randomized Controlled Non Blinded Multicenter Study. Assessing Feasibility.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 82 (actual)
• Sponsor: University of Southern Denmark · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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)

Conditions

• Pelvic Organ Prolapse

Interventions

Type	Name	Description
OTHER	decision aid developed for pelvic organ prolapse	Conversation based upon the inter face in the Electronic patient journal.

Timeline

• Start date: 2018-06-07
• Primary completion: 2019-03-22
• Completion: 2019-04-26
• First posted: 2018-10-16
• Last updated: 2019-05-03

Locations

3 sites across 1 country: Denmark