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Completed

NCT Number: NCT04204590

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

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.

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Key information

Conditions

Polypharmacy

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lemborgh

Sittard, Limburg, 6135CV, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Deprescribing algorithm

Other

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.

Primary outcomes

  1. Decrease in pill burden (the number of statins and PPI's)

    Time frame: 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.

  2. Decrease in pill burden (the dose of statins and PPI's)

    Time frame: 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 outcomes

  1. All possible negative side effects of deprescribing (e.g. nausea, symptom recurrence)

    Time frame: From intervention to six months after intervention

    All possible negative effects of deprescribing as recognised by the doctor involved, e.g. symptom recurrence.

  2. Feasibility to use this algorithm.

    Time frame: 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?

Sponsors and collaborators

Lead sponsor

Zuyderland Medisch Centrum

Other

Registry information

Official study title

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

Acronym: FeDeS+P

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Dec 19, 2019
Registry last updated
Dec 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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