Clinical trial NCT03706716: Testing a Decision Aid for Women With Urogenital Prolapse
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pelvic Organ Prolapse
Keywords: shared decision making
Lead sponsor: University of Southern Denmark
Sponsor class: OTHER
First posted: 2018-10-16
Enrollment: 82
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Arm A - intervention /consultation with use of decision aid Arm B - Controls / consultation without use of decision aid
Primary purpose: HEALTH_SERVICES_RESEARCH

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)

Eligibility criteria: 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

Primary outcomes:
measure: PROM of the shared decision making process
timeFrame: 1 hour immediately after the decision on treatment was taken
Secondary outcomes:
measure: PROM of Satisfaction with decision
timeFrame: 1 hour immediately after the decision on treatment was taken
Other outcomes:
Locations:
city: Aabenraa
country: Denmark
facility: Hospital of Southern Jutland
city: Kolding
country: Denmark
facility: Hospital of Lillebaelt, Kolding
city: Odense
country: Denmark
facility: Odense University Hospital
Study officials:
affiliation: Gynecology dep, Southern hospital of Jutland
name: Mette Hulbaek, Ph.d. stud.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hulbaek M, Primdahl J, Birkelund R, Al-Kozai SAH, Barawi S, Ebbesen NT, Nielsen JB. A Preference-Sensitive Online Instrument to Support Shared Decision Making for Patients With Pelvic Organ Prolapse: A Pilot Multicenter Randomized Controlled Trial. Comput Inform Nurs. 2021 Jul 12;39(11):714-724. doi: 10.1097/CIN.0000000000000789.