Deprescribing and Health-related Effects

Chronic Disease Clinical Trial

Official title:

Effective Deprescribing in Primary Care Without Deterioration of Health-related Outcomes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05721534
• Other study ID #: K2023-008
• Status: Completed
• Start date: January 1, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: February 2023
• Source: Aalborg University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

In a primary care settled quality improvement project aiming to deprescribe medication through a medication review intervention, we investigated how the implemented medication changes affected health-related outcomes in real-life patients.

Description:

The project was approved by the Management in the Municipality of Frederikshavn. According to Danish legislation, no formal permission from the national or regional Committee on Health Research Ethics was required for this type of study, as patients were not treated inferior to usual care and no biological material was collected. It was conducted as a quality improvement project and informed consent was not required for the specific data collected. The study is in compliance with the General Data Protection Regulation and a part of North Denmark Region's record of processing activities (K2023-008).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 87
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2021
• Gender: All
• Age group: 50 Years to 105 Years

Eligibility

Inclusion Criteria:

• new residents and residents that had not yet attended a consultation focusing on pharmacological treatment in The Chronic Care Model.

• patients were invited for the consultation focusing on pharmacological treatment in the month of their birthday and, thereby, included randomly and consecutively throughout the study period.

Exclusion Criteria:

• unable to collaborate on follow-up questionnaires

Related Conditions & MeSH terms

• Chronic Disease

Intervention

Other:
• Medication review
Annual consultation focusing on pharmacological treatment. This specific consultation constituted the "intervention". It included a structured review of the patient's health state, in addition to a structured medication review with a focus on appropriate medication and deprescribing.

Locations

Country	Name	City	State
Denmark	Aalborg University Hospital	Aalborg

Sponsors (3)

Lead Sponsor	Collaborator
Anne Estrup Olesen	Frederikshavn Kommune, Frederikshavn, Denmark, Lægeklinikken Frederikshavn, Frederikshavn, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	self-reported health status	(on a scale from 1 to 10)	4 months
Secondary	general condition	(rated on a 5-point Likert Scale)	4 months
Secondary	functional level	rated on a 5-point Likert Scale	4 months