Plain English Summary
Background and study aims
Ageing has become a worldwide reality and presents new challenges for the health care system. Research has shown that the prescription of potentially inappropriate medications (PIMs) happens a lot for older people, especially in nursing homes (NH). The use of PIMs is associated with bad side effects (or adverse drug events (ADEs)), hospitalizations, death and healthcare costs.
The Come-On study aims to investigate the effect of a complex, multifaceted intervention (that is, a programme with many different features), including training, local concertation (partnerships) and multidisciplinary case conferences (conferences covering cases involving a number of diseases), on whether the use of medicines for older people in Belgian nursing homes is appropriate.
Who can participate?
Nursing home residents that are at least 65 years old, living in a participating nursing homes under the care of a participating general practitioner (GP).
What does the study involve?
Participating nursing homes are randomly allocated into one of two groups. Those in group 1 (intervention group) hold four-monthly case conferences between the nurse, the GP and the pharmacist for each resident. Additional case conferences can be organized after hospitalization or upon entry in palliative care. In each case, a review of the medication that the resident is taking is done in order to optimize their medication profile (i.e. make sure that they are on the best combination of medications). A web application, built for this purpose, supports data collection and data sharing between health care professionals (HCPs) in the intervention arm. It also supports the documentation and follow-up of drug-related problems (DRPs) and related interventions/treatments. Education and training, both through e-learning and on-site sessions is provided to participating health care professionals from the intervention group. Furthermore, nursing homes in the intervention group work together in discussing and coming to an agreement on the appropriate use of two types of medication (antidepressants and lipid-lowering drugs).Nursing homes in group 2 (control group) deliver usual care.
What are the possible benefits and risks of participating?
The main benefit for participants in this study is the evaluation and the optimization of their medication profile. The information of this study can contribute to an improved medication policy for other nursing home residents, not included in the study. This study contains no risks for participating residents.
Where is the study run from?
A total of 63 nursing homes where recruited in this study. It is organized by KU Leuven and the University in Louvain-la-Neuve (Belgium).
When is the study starting and how long is it expected to run for?
January 2015 to June 2016
Who is the funding body of the study?
National Institute for Health and Disability Insurance (NIHDI) of Belgium
Who is the main contact?
1. Professor Veerle Foulon (scientific)
2. Professor Anne Spinewine (scientific)
Trial website
Contact information
Type
Scientific
Primary contact
Prof Veerle Foulon
ORCID ID
Contact details
KU Leuven
Onderwijs en Navorsing II
Clinical Pharmacology and Pharmacotherapy
Herestraat 49
box 521
Leuven
3000
Belgium
Type
Scientific
Additional contact
Prof Anne Spinewine
ORCID ID
Contact details
Université catholique de Louvain
Louvain Drug Research Institute
Clinical Pharmacy Research Group
Avenue E Mounier 72
B1.72.02
Brussels
1200
Belgium
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
s57145
Study information
Scientific title
A Collaborative approach to Optimise MEdication use for Older people in Nursing homes (the COME-ON study): a cluster controlled trial
Acronym
COME-ON
Study hypothesis
A complex, multifaceted intervention that consists of a multidisciplinary medication review, supported by training and local concertation, will improve the appropriateness of use of medicines for older people in Belgian nursing homes (NHs).
Ethics approval
Ethical Committee of the University Hospitals Leuven, 21 October 2014, reference number: s57145 (ML11035)
Study design
Multi-centre cluster controlled trial using parallel groups
Primary study design
Interventional
Secondary study design
Cluster randomised trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
Optimization of medication
Intervention
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 .
Nursing homes allocated to the control group will deliver usual care and will be paid for data collection.
Intervention type
Other
Phase
Drug names
Primary outcome measures
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.
Secondary outcome measures
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
Overall trial start date
01/01/2015
Overall trial end date
30/06/2016
Reason abandoned
Eligibility
Participant 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
Participant type
Mixed
Age group
Senior
Gender
Both
Target number of participants
Recruitment of 63 nursing homes and 2205 nursing home residents (63 clusters; in each nursing home 35 residents included)
Participant exclusion criteria
1. Short stay or revalidation
2. Receiving palliative care (according to GP's evaluation)
3. Refusal of resident to participate
Recruitment start date
01/01/2015
Recruitment end date
01/04/2015
Locations
Countries of recruitment
Belgium
Trial participating centre
KU Leuven
Onderwijs en Navorsing II
Clinical Pharmacology and Pharmacotherapy
Herestraat 49, Box 521
Leuven
3000
Belgium
Trial participating centre
Université catholique de Louvain (University in Louvain-la-Neuve)
Louvain Drug Research Institute
Clinical Pharmacy Research Group
Avenue E Mounier 72, B1.72.02
Brussels
1200
Belgium
Sponsor information
Funders
Funder type
Not defined
Funder name
National Institute for Health and Disability Insurance (NIHDI) of Belgium
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2016 protocol in: http://implementationscience.biomedcentral.com/articles/10.1186/s13012-016-0394-6