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

NCT04204590 | Completed DMC

• 1 other identifier: Z2018001
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Polypharmacy

Keywords

Deprescribing

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

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

  From intervention to six months after intervention

• Feasibility to use this algorithm.

  3 and 6 months after intervention

Study Arms (1)

Participants

OTHER

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

Interventions

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.

Participants

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant uses a statin and/or a proton pump inhibitor.
• Participant signs informed consent.
• Participant is a nursing home resident.

You may not qualify if:

• Participant is there for short term nursing home admission (\<3 months)
• Participant is there for hospice admission.

Sponsors & Collaborators

• Zuyderland Medisch Centrum: lead

Study Sites (1)

Lemborgh

Sittard, Limburg, 6135CV, Netherlands

Location

Study Officials

• Jos Schols, Prof. Dr.

  Principal Investigator

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: May 1, 2018
• First Posted: December 19, 2019
• Study Start: April 2, 2018
• Primary Completion: July 3, 2019
• Study Completion: July 3, 2019
• Last Updated: December 19, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)