Skip to main content
Clinical Trials/NCT06110975
NCT06110975
Active, not recruiting
Not Applicable

Deprescribing dRugs for Overactive Bladder in the Elderly in General Practice - a Randomized Controlled Trial With a Nested Mixed Methods Study

Anne Estrup Olesen1 site in 1 country72 target enrollmentDecember 1, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Overactive Bladder
Sponsor
Anne Estrup Olesen
Enrollment
72
Locations
1
Primary Endpoint
Difference in proportion of patients receiving drugs for overactive bladder
Status
Active, not recruiting
Last Updated
5 months ago

Overview

Brief Summary

The objective is to understand and evaluate the effectiveness of a deprescribing intervention in primary care, specifically targeting medications for overactive bladder in individuals aged 65 or older.

Detailed Description

Potentially inappropriate medication is prescribed medications with an unfavorable risk-benefit profile, for which there might be better, safer, or more cost-effective alternatives. Anticholinergic drugs for Overactive Bladder (OAB) is an example of a potentially inappropriate medication in the elderly, calling for attention and possible deprescribing. Due to their crucial role in maintaining a patient's medication regimen, primary care settings are widely regarded as the optimal location for conducting medication reviews and deprescribing interventions. This study utilizes a mixed methods explanatory sequential design, nested in a randomised controlled trial to explore deprescribing drugs for Overactive Bladder (OAB). General practices will be randomized into two groups. The intervention group will then be evaluated in a mixed methods setup and finish the study with a comparison to the control group. The mixed methods approach employs a quantitative approach following the intervention group and investigates the prevalence of deprescribing the drugs in question. Secondly, a qualitative approach will be used to delve into the experiences of general practitioners (GPs), support staff, and patients during the deprescribing process. Finally, the quantitative and qualitative findings are merged to gain a comprehensive understanding of deprescribing for OAB. This integrated approach enhances insights and informs future interventions and recommendations. After the mixed methods studies are completed the control group will be used in an overall comparison of the two groups using registry data

Registry
clinicaltrials.gov
Start Date
December 1, 2023
End Date
December 1, 2026
Last Updated
5 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Anne Estrup Olesen
Responsible Party
Sponsor Investigator
Principal Investigator

Anne Estrup Olesen

Professor

Aalborg University Hospital

Eligibility Criteria

Inclusion Criteria

  • patient must have been prescribed one of the following drugs for OAB within the last 14 months
  • patient must be able to speak and understand Danish

Exclusion Criteria

  • too cognitively impaired to participate or otherwise unfit to participate as estimated by general practitioner
  • receiving neurological or urogenital ambulatory care for their overactive bladder symptoms

Outcomes

Primary Outcomes

Difference in proportion of patients receiving drugs for overactive bladder

Time Frame: 6 months

The primary outcome will be the difference in the proportion of patients receiving drugs for overactive bladder before and after a 6-month follow-up period.

Secondary Outcomes

  • Changes and distribution of bladder symptoms(6 months)
  • The proportion of patients where deprescribing was not initiated(6 months)
  • proportion of patients in the intervention group who had deprescribing initiated but not sustained(6 months)

Study Sites (1)

Loading locations...

Similar Trials