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

Polypharmacy Clinical Trial

— FeDeS+P  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04204590
• Other study ID #: Z2018001
• Status: Completed
• Phase: N/A
• Start date: April 2, 2018
• Est. completion date: July 3, 2019

Study information

• Verified date: December 2019
• Source: Zuyderland Medisch Centrum
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: July 3, 2019
• Est. primary completion date: July 3, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Polypharmacy

Intervention

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.

Locations

Country	Name	City	State
Netherlands	Lemborgh	Sittard	Limburg

Sponsors (1)

Lead Sponsor	Collaborator
Zuyderland Medisch Centrum

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	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
Secondary	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

External Links

•   Deprescribing algorithm