Testing a Decision Aid for Women With Urogenital Prolapse

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.

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.

Study Overview

• Status: Completed
• Conditions: Pelvic Organ Prolapse
• Intervention / Treatment: Other: decision aid developed for pelvic organ prolapse

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)

• Study Type: Interventional
• Enrollment (Actual): 82
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Aabenraa, Denmark, 6200
    • Hospital of Southern Jutland
  • Kolding, Denmark, 6000
    • Hospital of Lillebaelt, Kolding
  • Odense, Denmark, 5000
    • Odense University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: 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.	Other: decision aid developed for pelvic organ prolapse; Conversation based upon the inter face in the Electronic patient journal.
NO_INTERVENTION: 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Southern Denmark
• Investigators: Principal Investigator: Mette Hulbaek, Ph.d. stud., Gynecology dep, Southern hospital of Jutland

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 7, 2018
• Primary Completion (ACTUAL): March 22, 2019
• Study Completion (ACTUAL): April 26, 2019

Study Registration Dates

• First Submitted: October 11, 2018
• First Submitted That Met QC Criteria: October 15, 2018
• First Posted (ACTUAL): October 16, 2018

Study Record Updates

• Last Update Posted (ACTUAL): May 3, 2019
• Last Update Submitted That Met QC Criteria: April 30, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: shared decision making
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Prolapse; Pelvic Organ Prolapse
• Other Study ID Numbers: OP_613

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No