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

Study Overview
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Brief Summary
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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.

Official Title
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Feasibility Study of a Systematic Approach for Deprescribing of Statins and Proton Pump Inhibitors in Nursing Home Residents

Conditions
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Polypharmacy

Intervention / Treatment
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* Other: Deprescribing algorithm


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: A multicentre, unblinded, single group (pre-comparison and post-comparison) feasibility study.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Participants<br>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. | Other: Deprescribing algorithm<br>* For this study an implicit, evidence-supported and patient-centred algorithm has been developed. The outcome of the algorithm is an advice to the doctor to deprescribe or not deprescribe the statin and/or PPI.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decrease in pill burden (the number of statins and PPI's) | 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. | 3 and 6 months after intervention. | 
| Decrease in pill burden (the dose of statins and PPI's) | 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. | 3 and 6 months after intervention. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All possible negative side effects of deprescribing (e.g. nausea, symptom recurrence) | All possible negative effects of deprescribing as recognised by the doctor involved, e.g. symptom recurrence. | From intervention to six months after intervention | 
| Feasibility to use this algorithm. | 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? | 3 and 6 months after intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Deprescribing