A collaborative approach to optimise medication use for older people in nursing homes: a cluster controlled trial

Not Applicable

Completed

• Conditions: Optimization of medication; Not Applicable

• Registration Number: ISRCTN66138978
• Lead Sponsor: KU Leuven

Brief Summary

2016 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/26968520 protocol 2019 Results article in https://www.ncbi.nlm.nih.gov/pubmed/31402136 results (added 14/08/2019) 2019 Other publications in https://www.ncbi.nlm.nih.gov/pubmed/31829252 process evaluation (added 13/12/2019) 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/36633299/ Drug–drug interaction results (added 09/01/2024)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-11-18
• Study Completion: 2016-06-30
• Last Update Posted: 22 January 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 1804

Inclusion Criteria

1. Participating nursing homes:
The National Institute for Health and Disability Insurance (NIHDI) of Belgium launched a call in July 2013 to all Belgian nursing homes to apply for participation to the Come-On study. In total, 72 nursing homes were considered as eligible candidates. After the exclusion of duplicates (in case of the same coordinating physician, the same pharmacist or the same board of directions), 63 submission files were restrained.
In agreement with NIHDI we decided to use the resulting 63 files to generate an intervention group of 30 NHs (as stipulated in the call launched by NIHDI in July 2013) and a control group of 33 NHs.
Because of political reasons, it was decided on beforehand that each ‘entity’ in Belgium (12 in total: five Flemish provinces, five Walloon provinces, German-speaking community and Brussels-Capital Region) would have at least one NH in the intervention group.
The number of NHs to be selected from each of the eight remaining entities was calculated on the number of inhabitants. We further stratified, within these entities, for experience with case conferencing and type of delivering pharmacy (hospital pharmacy versus community pharmacy). This resulted in 17 groups.
Randomization within the groups was performed with SPSS.

2. Participating nursing home residents:
2.1. Resident of participating nursing home
2.2. Participating GP
2.3. 65 years and older
2.4. A signed informed consent

Exclusion Criteria

1. Short stay or revalidation
2. Receiving palliative care (according to GP's evaluation)
3. Refusal of resident to participate

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome measure relates to appropriateness of prescribing. It considers:<br>1. Proportion of residents with improvement in Potential Inappropriate Medication (PIM) / Potential Prescribing Omission (PPO) (overall score) between baseline and end of study<br>2. Median number of PIMs/PPOs per patient (difference between baseline and end of study) . <br><br>PIMs/PPOs will be identified by the research team from a pre-defined list of explicit criteria that includes STOPP-START (version 2) and Beers criteria.