NCT03655405

Brief Summary

This study will evaluate the effects of a pharmacist-led, deprescribing-focused medication review on the use of inappropriate medications by nursing home residents

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 30, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 31, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

October 30, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 22, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 22, 2019

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

May 19, 2021

Completed
Last Updated

May 19, 2021

Status Verified

April 1, 2021

Enrollment Period

10 months

First QC Date

August 30, 2018

Results QC Date

November 10, 2020

Last Update Submit

April 28, 2021

Conditions

PolypharmacyInappropriate Prescribing

Keywords

DeprescribingNursing HomePotentially Inappropriate Medication

Outcome Measures

Primary Outcomes (1)

  • Number of Inappropriate Medication at Follow-up

    Number of inappropriate medications prescribed at follow-up, assessed using the French translation of STOPP v2.

    4 months

Secondary Outcomes (6)

  • Number of Potentially Inappropriate DDDs Prescribed to Participants at Follow-up

    4 months

  • Number of Chronic Drugs Prescribed to Participants

    4 months

  • Number of Chronic DDDs Prescribed to Participants

    4 months

  • Number of New Drugs Prescribed as a Result of the Intervention

    4 months

  • Health-related Quality of Life

    4 months

  • +1 more secondary outcomes

Other Outcomes (7)

  • Number of Deaths

    4 months

  • Number of Participants Hospitalized

    4 months

  • Days Spent in Hospital

    4 months

  • +4 more other outcomes

Study Arms (2)

Individual Deprescribing Intervention

EXPERIMENTAL

Participants allocated to the intervention arm will receive the Individual Deprescribing Intervention (pharmacist-led medication review, followed by the creation of a deprescribing plan by the pharmacist, physician and responsible nurse).

Other: Individual Deprescribing Intervention

Control

NO INTERVENTION

Participants allocated to the control group will receive usual care.

Interventions

Individual Deprescribing InterventionOTHER

The pharmacist responsible for the nursing home will perform a medication review (type 3). The results of this review will be discussed with the physician and nurse responsible for this participant, with the goal of creating a personalised deprescribing plan. Once validated by the physician, this plan will be submitted to the participant for approval.

Individual Deprescribing Intervention

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Take 5 or more prescribed drugs daily;
  • Reside in the Nursing Home since at least 4 months.

You may not qualify if:

  • Physician judges that discussing deprescribing with them risks destabilising them.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre de Pharmacie Communautaire

Lausanne, Canton of Vaud, 1011, Switzerland

Location

Related Publications (1)

  • Cateau D, Ballabeni P, Mena S, Bugnon O, Niquille A. Deprescribing in nursing homes: Protocol for nested, randomised controlled hybrid trials of deprescribing interventions. Res Social Adm Pharm. 2021 Apr;17(4):786-794. doi: 10.1016/j.sapharm.2020.05.026. Epub 2020 May 27.

    PMID: 32622774DERIVED

Related Links

Results Point of Contact

Title
Dr Anne Niquille
Organization
a. Community Pharmacy, Center for Primary Care and Public Health (Unisanté), University of Lausanne, Switzerland
anne.niquille@unisante.ch
+41213144845

Study Officials

  • Olivier Bugnon, Prof

    ISPSO, Universties of Geneva and Lausanne, Switzerland

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

August 30, 2018

First Posted

August 31, 2018

Study Start

October 30, 2018

Primary Completion

August 22, 2019

Study Completion

August 22, 2019

Last Updated

May 19, 2021

Results First Posted

May 19, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will share

Data are available from the investigators upon reasonable request.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
10-year availability
Access Criteria
Data are available from the investigators upon reasonable request.

Locations

CH(1)