Pelvic Organ Prolapse Clinical Trial
Official title:
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.
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.
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)
;
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