Clinical trial NCT02986425: OPtimising thERapy to Prevent Avoidable Hospital Admissions in the Multimorbid Older People
Official title: OPERAM: OPtimising thERapy to Prevent Avoidable Hospital Admissions in the Multimorbid Older People: a Cluster Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: 3 or More Chronic Conditions for 6 Months or Longer
5 or More Regular Drugs
Keywords: Drug Utilization Review
Older people
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
Collaborators: name: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
name: Cork University Hospital
name: UMC Utrecht
name: University of Basel
name: Université Catholique de Louvain
name: Utrecht University
name: University of Bern
name: European Commission
name: State Secretariat for Education Research and Innovation, Switzerland
First posted: 2016-12-08
Enrollment: 2009
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this Randomised Controlled Trial (RCT) is to evaluate whether the Systematic Tool to Reduce Inappropriate Prescribing (STRIP) including STRIP assistant (STRIPA) implemented by an appropriately qualified team will lead to an improvement in clinical and economic outcomes among patients aged 70 years and more with multimorbidity and polypharmacy.

Detailed description: Background:

Drug-related morbidity and mortality is an increasing problem in European healthcare systems. Multimorbidity, polypharmacy and old age are important risk factors for drug-related hospital admissions (DRA). The reported incidence of DRAs in the elderly may be as high as 30% of all acute cases, and about half of DRAs are likely to be preventable. They are mainly related to prescribing problems and non-compliance with drug regimens. A significant proportion of healthcare costs are spent on unnecessary interventions and inappropriate medications. The Systematic Tool to Reduce Inappropriate Prescribing (STRIP) is a structured method to perform a medication review to optimise pharmacotherapy.

Design:

European multi-centre, cluster randomised, controlled trial of people aged 70 years or older, with multimorbidity and polypharmacy, being on an ambulatory visit or on a hospital stay in one of the four participating centres in Ireland, Belgium, Switzerland and the Netherlands. A cluster is defined around a treating physician, i.e. the treating physician is randomised and defines the allocation of his patients. Clusters of patients will be randomised to the intervention arm receiving STRIP for optimising therapy or to the control arm undergoing usual clinical care. The patients of physicians who are allocated to the intervention group will undergo a systematic drug review and pharmacotherapy optimisation by a physician and a pharmacist using STRIP, including the STRIPA software. That provides the research team with a recommendation of changes in the patient's medication. Based on STRIPA recommendation and agreement on changes to the patients' pharmacotherapy between the team of the research physician and pharmacist and the prescribing physician, will the patient receive structured counselling about his/her medication; general practitioners will receive a report. Patients will be further followed for 1 year with follow-up phone calls after 2, 6 and 12 months. For the purpose of this trial, all hospitalisations during follow-up of participants will be adjudicated to assess their relationship to adverse drug events.

Objectives:

The primary objective is to assess the effect of a structured medication review and pharmacotherapy optimisation using the STRIP on drug-related hospitalisations (DRA) caused by over-, mis-, and underuse or over-, mis-, and underprescribing of medications.

Secondary objectives will be to assess the impact of pharmacotherapy optimisation on falls, quality of life, polypharmacy, medication changes, activities of daily living, and mortality.

Statistical considerations:

80 clusters with a cluster size ranging from 12 to 38 participants will be included. Therefore, 2000 patients, 1000 patients in each arm, will be recruited over 18 months. The trial will have 80% power with this sample size.

The primary analysis will be an intention-to-treat (ITT) analysis, whereby all randomised patients will be included in the group they were allocated to.

The primary outcome of drug-related admission will be analysed using a random-effects competing risk proportional hazards model that accounts for the competing risk of death and for clustering of data within centre and prescribing physician.

Overall survival will be analysed using a random-effects Cox proportional hazards model that accounts for clustering of data within centre and prescribing physician. The analysis of falls will also take into account the competing risk of death. Continuous outcomes will be analysed by random-effects linear regression. All effect measures will be accompanied by 95% confidence intervals and all p-values will be two-sided.

Eligibility criteria: Inclusion Criteria:

* People 70 years of age or older
* Multimorbidity: 3 or more coexistent chronic conditions defined by 3 distinct International Classification of Diseases (ICD-10) codes with an estimated duration of 6 months or more or based on a clinical decision
* Polypharmacy i.e. five or more different regular drugs (defined as authorised medications with registration numbers) for more than 30 days.
* In inpatient: Estimated minimal length of stay within the cluster is sufficient to apply the intervention
* If outpatient: prescribing physician has GP function and has a planned appointment to conduct intervention

Exclusion Criteria:

* Inability to provide informed consent or to obtain informed consent from a proxy for patients with cognitive impairment
* Direct admission to palliative care (\< 24h after admission)
* Has passed or will pass a systematic structured drug review during this hospitalisation or within the last two months

Primary outcomes:
measure: Patients with confirmed DRA after discharge from the index hospitalisation
timeFrame: 12 months
Secondary outcomes:
measure: Number of survivors
timeFrame: 12 months
measure: Number of cancer deaths
timeFrame: 12 months
measure: Number of patients with hospitalisations
timeFrame: 12 months
measure: Number of patients with falls
timeFrame: 12 months
measure: Patients' degree of poly-pharmacy
timeFrame: 12 months
measure: Patients' quality of life
timeFrame: 12 months
measure: Patients' level of pain/discomfort
timeFrame: 12 months
measure: Patients' basic activities of daily living
timeFrame: 12 months
measure: Patients' drug compliance
timeFrame: 12 months
measure: Number of clinically significant drug-drug interactions
timeFrame: 2 months
measure: Number of drug overuse
timeFrame: 2 months
measure: Number of drug underuse
timeFrame: 2 months
measure: Number of potentially inappropriate medications
timeFrame: 2 months
measure: Number of patients with a serious adverse event
timeFrame: 12 months
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
facility: Cliniques universitaires Saint-Luc
city: Cork
country: Ireland
facility: Dept. of Medicine (Geriatrics), University College Cork
city: Utrecht
country: Netherlands
facility: Universitair Medisch Centrum Utrecht
city: Bern
country: Switzerland
facility: University of Bern and University Hospital Bern (Inselspital)
Study officials:
affiliation: Head of Ambulatory Care Department of General Internal Medicine Inselspital, Bern University Hospital, University of Bern, Switzerland; and Institute of Primary Health Care (BIHAM), University of Bern
name: Nicolas Rodondi, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
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