Testing a Decision Aid for Women With Urogenital Prolapse

University of Southern Denmark (SDU)

Status: Completed

Conditions: Pelvic Organ Prolapse

Treatments: Other: decision aid developed for pelvic organ prolapse

Study type: Interventional

Funder types: Other

Identifiers

NCT03706716

OP_613

Details and patient eligibility

About

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.

Full 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)

Enrollment: 82 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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82 participants in 2 patient groups

Intervention with use of decision aid in the consultation

Other group

Description:

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.

Treatment:

Other: decision aid developed for pelvic organ prolapse

Control with no use of decision aid in the consultation

No Intervention group

Description:

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