Deprescribing and Health-related Effects

February 1, 2023 updated by: Anne Estrup Olesen

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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).

Study Type

Observational

Enrollment (Actual)

87

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aalborg, Denmark, 9000
        • Aalborg University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 105 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The study included care home residents living in selected care homes, in which the GPF was associated "care home doctors", and community-dwelling patients with chronic disease listed with the GPF.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Care home residents
The intervention was offered to new residents and residents that had not yet attended a consultation focusing on pharmacological treatment in The Chronic Care Model.
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.
Other Names:
  • Medication review with focus on deprescribing
Community-dwelling patients with chronic disease
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.
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.
Other Names:
  • Medication review with focus on deprescribing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
self-reported health status
Time Frame: 4 months
(on a scale from 1 to 10)
4 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
general condition
Time Frame: 4 months
(rated on a 5-point Likert Scale)
4 months
functional level
Time Frame: 4 months
rated on a 5-point Likert Scale
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Anne Estrup Olesen

Collaborators

Frederikshavn Kommune, Frederikshavn, Denmark
Lægeklinikken Frederikshavn, Frederikshavn, Denmark

Investigators

  • Study Chair: Anne E Olesen, Professor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2020

Primary Completion (ACTUAL)

December 31, 2021

Study Completion (ACTUAL)

December 31, 2022

Study Registration Dates

First Submitted

February 1, 2023

First Submitted That Met QC Criteria

February 1, 2023

First Posted (ACTUAL)

February 10, 2023

Study Record Updates

Last Update Posted (ACTUAL)

February 10, 2023

Last Update Submitted That Met QC Criteria

February 1, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • K2023-008

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Chronic Disease

Clinical Trials on Medication review

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Netherlands

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe