Pelvic Organ Prolapse
Conditions
Keywords
shared decision making
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)
Interventions
OTHERdecision aid developed for pelvic organ prolapse
Conversation based upon the inter face in the Electronic patient journal.
Sponsors
University of Southern Denmark
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
Arm A - intervention /consultation with use of decision aid Arm B - Controls / consultation without use of decision aid
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Denmark
Outcome results
None listed