Deprescribing dRrugs for Overactive Bladder in General Practice (DROP)

Overactive Bladder Clinical Trial

— DROP  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06110975
• Other study ID #: K2023-012
• Status: Enrolling by invitation
• Phase: N/A
• Start date: December 1, 2023
• Est. completion date: December 1, 2026

Study information

• Verified date: January 2024
• Source: Aalborg University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 72
• Est. completion date: December 1, 2026
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 95 Years

Eligibility

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

Related Conditions & MeSH terms

• Deprescribing
• Overactive Bladder
• Urinary Bladder, Overactive

Intervention

Other:
• deprescribing-intervention
The clinical guideline on "Deprescribing drugs for OAB" in The North Denmark Region serves as the basis for the intervention. The guideline provides recommended procedures for the deprescribing process. The guideline offers procedures for the deprescribing process and includes a deprescribing algorithm and a symptom questionnaire designed to evaluate the impact of medications utilized in the treatment of OAB.

Locations

Country	Name	City	State
Denmark	Aalborg University Hospital	Aalborg

Sponsors (2)

Lead Sponsor	Collaborator
Anne Estrup Olesen	University College of Northern Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	A qualitative score measuring experiences	Interviews to explore how GPs, staff members, and patients have experienced the intervention and which strategies have been used for the successful deprescribing of drugs for overactive bladder to understand when and how the algorithm is useful using thematic analysis	Approximately 6 months after the study initiates
Primary	Difference in proportion of patients receiving drugs for overactive bladder	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.	6 months
Secondary	proportion of patients in the intervention group who had deprescribing initiated but not sustained	Descriptive characteristics of the proportion of patients in the intervention group who had deprescribing initiated but not sustained.	6 months
Secondary	The proportion of patients where deprescribing was not initiated	Descriptive characteristics of the proportion of patients in the intervention group where deprescribing was not initiated.	6 months
Secondary	Changes and distribution of bladder symptoms	Descriptive characteristics and distribution of bladder symptoms between and within the groups before and after the intervention	6 months