Testing a Decision Aid for Women With Urogenital Prolapse

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-07

Study Completion Date

2019-04-26

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.

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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)

Conditions

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Pelvic Organ Prolapse

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Arm A - intervention /consultation with use of decision aid Arm B - Controls / consultation without use of decision aid

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Intervention with use of decision aid in the consultation

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.

Group Type OTHER

decision aid developed for pelvic organ prolapse

Intervention Type OTHER

Conversation based upon the inter face in the Electronic patient journal.

Control with no use of decision aid in the consultation

Without decision aid / The conversation during the consultation will follow the general standard for consultation conversations in the department.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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decision aid developed for pelvic organ prolapse

Conversation based upon the inter face in the Electronic patient journal.

Intervention Type OTHER

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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No