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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04204590
Acronym
FeDeS+P
Enrollment
75
Registered
2019-12-19
Start date
2018-04-02
Completion date
2019-07-03
Last updated
2019-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Polypharmacy

Keywords

Deprescribing

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.

Interventions

OTHERDeprescribing algorithm

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.

Sponsors

Zuyderland Medisch Centrum
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Intervention model description

A multicentre, unblinded, single group (pre-comparison and post-comparison) feasibility study.

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
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.
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.

Secondary

MeasureTime frameDescription
All possible negative side effects of deprescribing (e.g. nausea, symptom recurrence)From intervention to six months after interventionAll possible negative effects of deprescribing as recognised by the doctor involved, e.g. symptom recurrence.
Feasibility to use this algorithm.3 and 6 months after interventionThree 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?

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026