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.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Pelvic Organ Prolapse
- Sponsor
- University of Southern Denmark
- Enrollment
- 82
- Locations
- 3
- Primary Endpoint
- PROM of the shared decision making process
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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)
Investigators
Eligibility Criteria
Inclusion Criteria
- •urogenital prolaps symptoms
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
Outcomes
Primary Outcomes
PROM of the shared decision making process
Time Frame: 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 Outcomes
- PROM of Satisfaction with decision(1 hour immediately after the decision on treatment was taken)