Feasibility Study of a Systematic Approach for Deprescribing of Statins and PPI's.

Not Applicable

Completed

• Conditions: Polypharmacy
• Interventions: Other: Deprescribing algorithm

• Registration Number: NCT04204590
• Lead Sponsor: Zuyderland Medisch Centrum

Brief Summary

Deprescribing, the process of safely reducing or discontinuing unnecessary or harmful medication, has the potential to decrease polypharmacy and improve health outcomes. In this study a structured implicit algorithm, focusing on both extrinsic medication factors (eg change in disease) and intrinsic patient factors (eg. pill burden) will be used.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-04-02
• Study First Submitted: 2018-05-01
• Primary Completion: 2019-07-03
• Study Completion: 2019-07-03
• Status Verified: 2019-12
• Study First Submitted QC: 2019-12-16
• Last Update Submitted: 2019-12-16
• Study First Posted: 2019-12-19
• Last Update Posted: 2019-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

• Participant uses a statin and/or a proton pump inhibitor.
• Participant signs informed consent.
• Participant is a nursing home resident.

Exclusion Criteria

• Participant is there for short term nursing home admission (<3 months)
• Participant is there for hospice admission.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Participants	Deprescribing algorithm	The aim of this study is to test the feasibility of this algorithm as an intervention to carry out deprescribing a targeted medication group, proton pump inhibitors (PPI's) and statins, among nursing home residents.

Primary Outcome Measures

Name	Time	Method
Decrease in pill burden (the dose of statins and PPI's)	3 and 6 months after intervention.	On T0 (intervention) and on T1 + T2 (3 and 6 months after intervention), we will measure the dose of PPI's and statins on the medication list of every participant. These are provided by the pharmacist.
Decrease in pill burden (the number of statins and PPI's)	3 and 6 months after intervention.	On T0 (intervention) and on T1 + T2 (3 and 6 months after intervention), we will measure the number of PPI's and statins on the medication list of every participant. These are provided by the pharmacist.

Secondary Outcome Measures

Name	Time	Method
Feasibility to use this algorithm.	3 and 6 months after intervention	Three and six months after intervention we will ask the participating doctors the next questions (per included participant): * What did the algorithm advice you?; * Did you follow the advice?; * Why dit you follow/deny the advice?
All possible negative side effects of deprescribing (e.g. nausea, symptom recurrence)	From intervention to six months after intervention	All possible negative effects of deprescribing as recognised by the doctor involved, e.g. symptom recurrence.

Trial Locations

Locations (1)

Lemborgh; 🇳🇱 Sittard, Limburg, Netherlands