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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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22 January 2024 |
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Main ID: |
ISRCTN66138978 |
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Date of registration:
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18/11/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A collaborative approach to optimise medication use for older people in nursing homes: a cluster controlled trial
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Scientific title:
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A Collaborative approach to Optimise MEdication use for Older people in Nursing homes (the COME-ON study): a cluster controlled trial |
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Date of first enrolment:
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01/01/2015 |
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Target sample size:
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2205 |
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Recruitment status: |
Completed |
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URL:
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https://www.isrctn.com/ISRCTN66138978 |
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Study type:
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Interventional |
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Study design:
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Multi-centre cluster controlled trial using parallel groups (Treatment)
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Phase:
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Not Applicable
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Countries of recruitment
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Belgium
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Contacts
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Name:
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Veerle
Foulon |
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Address:
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KU Leuven
Onderwijs en Navorsing II
Clinical Pharmacology and Pharmacotherapy
Herestraat 49, box 521
3000
Leuven
Belgium |
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Telephone:
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Email:
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Affiliation:
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Key inclusion & exclusion criteria
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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
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Optimization of medication
Not Applicable
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Intervention(s)
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The intervention is considered as a complex multifaceted intervention that is built up from three main components (for the intervention arm of the trial):
1. Education and training
Education and training, both through e-learning and on-site sessions, will be provided to participating health care professionals (HCPs). An e-learning platform is specifically designed to support this component.
2. Local concertations
Two meetings (i.e. local concertations) will be held on the level of the nursing home to discuss and generate consensus on the appropriate use of two specific medication classes (antidepressants and lipid-lowering drugs), and to stimulate collaboration.
3. Multidisciplinary case conferences
Four-monthly scheduled multidisciplinary case conferences between nurse, general practitioner and pharmacist will be conducted on a resident-level over a period of 12 months. Additional case conferences can be organized after hospitalization or upon entry in palliative care. Case conferences will facilitate a structured medication review in order to optimize the residents’ medication profile.
Two additional components should facilitate the intervention. First, using a web application that has been developed for data collection, will allow health care providers in the intervention group to share data and to prepare the medication review. Moreover, the web application provides the opportunity to document and follow-up drug-related problems and interventions. Second, a financial incentive will be provided to participating healthcare professionals for data collection and participation to case conferences.
Qualitative analysis will be incorporated in the study to provide insight into the intervention delivery and the acceptability of the intervention to different HCPs .
Nurs
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Primary Outcome(s)
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The primary outcome measure relates to appropriateness of prescribing. It considers:
1. Proportion of residents with improvement in Potential Inappropriate Medication (PIM) / Potential Prescribing Omission (PPO) (overall score) between baseline and end of study
2. Median number of PIMs/PPOs per patient (difference between baseline and end of study) .
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.
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Secondary Outcome(s)
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Resident level:
1. Appropriateness of prescribing:
1.1. PIMs and PPOs: prevalence per explicit criteria at baseline, middle and end of study
1.2. On a random subsample of patients and using an implicit approach for the evaluation of appropriateness:
1.2.1. Prevalence of PIMs/PPOs that can be considered as actually inappropriate on an individual basis
1.2.2. Appropriateness of prescribing at baseline and end of study using the Medication Appropriateness Index (MAI)
2. Medication use: median number of drugs per resident and classes of medications (ATC) at baseline, middle and end of study
3. Process of case conferences: number of case conferences per resident and per nursing home, reason for case conference, number of participating health care providers and duration of case conference at each case conference
4. Outcome of case conferences: characteristics of drug-related problems (DRPs) leading to treatment changes and proportion of modifications implemented at the next case conference
5. Clinical outcomes / residents’ status: death, hospital admissions, visits to emergency department, GP visits and consultations with specialists
6. Cost of medication, cost of medical care and cost of intervention
Nursing home level:
1. Facilitators and barriers, satisfaction of caregivers by semi-structured interviews and/or focus groups at the end of the study
2. Process analysis / fidelity to the intervention
2.1. Participation rate for educational sessions / e-learning at month 3 and at the end of the study
2.2. Number of local concertation meetings organized at each NH
2.3. Proportion and types of HCPs participating to local concertation
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Source(s) of Monetary Support
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National Institute for Health and Disability Insurance (NIHDI) of Belgium
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Ethics review
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Status:
Approval date:
Contact:
Old ethics approval format; Ethical Committee of the University Hospitals Leuven, 21 October 2014, reference number: s57145 (ML11035)
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Results
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Results available:
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Yes |
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Date Posted:
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Date Completed:
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30/06/2016 |
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URL:
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