Condition category
Not Applicable
Date applied
10/11/2015
Date assigned
18/11/2015
Last edited
14/03/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Organisation

KU Leuven

Sponsor details

Herestraat 49
Box 521
Leuven
3000
Belgium

Sponsor type

University/education

Website

Organisation

University in Louvain-la-Neuve (UCL)

Sponsor details

Avenue E Mounier 72 bte 01.72.02
Brussels
1200
Belgium

Sponsor type

University/education

Website

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

Publication citations

Additional files

Editorial Notes

14/03/2016: Publication reference added.