Optimization of medication Not Applicable
Conditions
Interventions
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 train
Sponsors
KU Leuven
University in Louvain-la-Neuve (UCL)
KU Leuven
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria: 1. Short stay or revalidation 2. Receiving palliative care (according to GP's evaluation) 3. Refusal of resident to participate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Belgium
Outcome results
None listed