Clinical trial NCT06110975: Deprescribing DRrugs for Overactive Bladder in General Practice (DROP)
Official title: Deprescribing DRugs for Overactive Bladder in the Elderly in General Practice - a Randomized Controlled Trial with a Nested Mixed Methods Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Overactive Bladder
Deprescribing
PIMS
Lead sponsor: Aalborg University Hospital
Sponsor class: OTHER
Collaborators: name: University College of Northern Denmark
First posted: 2023-11-01
Enrollment: 72
Sex: ALL
Minimum age (years): 65
Maximum age (years): 95
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Primary care clinics are randomized to the deprescribing intervention or control group. The control group is not contacted and comparison relies on register data.
Primary purpose: HEALTH_SERVICES_RESEARCH

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

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

Primary outcomes:
measure: Difference in proportion of patients receiving drugs for overactive bladder
timeFrame: 6 months
Secondary outcomes:
measure: proportion of patients in the intervention group who had deprescribing initiated but not sustained
timeFrame: 6 months
measure: The proportion of patients where deprescribing was not initiated
timeFrame: 6 months
measure: Changes and distribution of bladder symptoms
timeFrame: 6 months
Other outcomes:
measure: A qualitative score measuring experiences
timeFrame: Approximately 6 months after the study initiates
Locations:
city: Aalborg
country: Denmark
facility: Aalborg University Hospital
Study officials:
affiliation: Aalborg University Hospital
name: Anne E Olesen, Professor
role: PRINCIPAL_INVESTIGATOR
References: