Feasibility Study of a Systematic Approach for Deprescribing of Statins and PPI's. (FeDeS+P)

December 16, 2019 updated by: Zuyderland Medisch Centrum

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

75

Phase

  • Not Applicable

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

  • Netherlands
    • Limburg
      • Sittard, Limburg, Netherlands, 6135CV
        • Lemborgh

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

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 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

  • Primary Purpose: OTHER
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Participants
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 and 6 months after intervention.
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.
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)
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.
From intervention to six months after intervention
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?
3 and 6 months after intervention

Collaborators and Investigators

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

Sponsor

Zuyderland Medisch Centrum

Investigators

  • Principal Investigator: Jos Schols, Prof. Dr., Principal Investigator

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)

April 2, 2018

Primary Completion (ACTUAL)

July 3, 2019

Study Completion (ACTUAL)

July 3, 2019

Study Registration Dates

First Submitted

May 1, 2018

First Submitted That Met QC Criteria

December 16, 2019

First Posted (ACTUAL)

December 19, 2019

Study Record Updates

Last Update Posted (ACTUAL)

December 19, 2019

Last Update Submitted That Met QC Criteria

December 16, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Z2018001

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.

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