Testing a Decision Aid for Women With Urogenital Prolapse

Study Overview
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Brief Summary
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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
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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)

Official Title
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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.

Conditions
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Pelvic Organ Prolapse

Intervention / Treatment
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* Other: decision aid developed for pelvic organ prolapse


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Arm A - intervention /consultation with use of decision aid Arm B - Controls / consultation without use of decision aid
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Intervention with use of decision aid in the consultation<br>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. | Other: decision aid developed for pelvic organ prolapse<br>* Conversation based upon the inter face in the Electronic patient journal.<br>|
| No Intervention: Control with no use of decision aid in the consultation<br>Without decision aid / The conversation during the consultation will follow the general standard for consultation conversations in the department. | |

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PROM of Satisfaction with decision | Measurement of satisfaction with the decision for treatment of pelvic organ prolapse symptoms measured by questionnaire SWD | 1 hour immediately after the decision on treatment was taken | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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shared decision making