Polypharmacy Multimorbid elderly Hospital admissions Medication review
Conditions
Interventions
STRIP is a structured method to perform pharmacotherapy optimisation. This STRIP-intervention consists of 9 steps:
1. structured history taking of medication (SHIM)
2. recording medication and diagn
Sponsors
University Medical Center
Eligibility
Inclusion criteria
Inclusion criteria: Men and women 70 years of age or older Multimorbidity: 3 or more coexistent chronic conditions defined by 3 distinct ICD-10 codes with an estimated duration of 6 months or more. Polypharmacy i.e. five or more different regular drugs (defined as authorised medications with registration numbers) for more than 30 days. Estimated minimal length of stay within the cluster is sufficient to apply the intervention
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Outcome Patient-level The primary outcome is defined as the first confirmed DRA after discharge from the index hospitalisation within a period of 12 months. Hospitalisation is defined as a stay in an inpatient hospitalisation for longer than 24 hours. The following will not meet the criteria for a hospitalisation. -Visits to emergency room without inpatient hospitalisation (even if overnight) -Hospitalisation or prolonged hospitalisation for diagnostic or elective (surgical) procedures for pre-existing conditions -Admissions due to deliberate suicide attempts Confirmation of a drug-related hospital admission will be assessed by an independent and blinded adjudication committee (per site) composed of physicians and pharmacists. Prolongation of the index hospitalisation and prolongation of any following hospitalisations will not be adjudicated for drug-relatedness. Adjudication is done according to specific guidelines (see attachment). Study-level The primary outcome of the trial will be the comparison of the two trial groups with respect to DRA and expressed by the hazard ratio as the primary effect measure. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Outcomes Secondary objectives are to assess the impact of pharmacotherapy optimisation on economic parameters, health care utilisation, falls, mortality, quality of life, polypharmacy, medication changes, activities of daily living, and patient understandings of their medication. A qualitative assessment of patient preference will also be performed. The following secondary endpoints will be analysed: Up to 12 months after inclusion: - Survival (including causes of death) - Hospitalisation - Clinically significant drug-drug reaction (in case of a hospital admission) - Unnecessary drugs (in case of a hospital admission) - Drug underuse (in case of a hospital admission) - Potentially inappropriate medications (in case of a hospital admission) - Healthcare utilisation as measured by all unplanned hospitalisations, scheduled and unscheduled physician consultations (differentiated by profession), and visits to the emergency room without hospital admission - Falls reported by participants, as defined in the corresponding SOP. - Informal care received - Unit costs for participating countries that will stem from external sources - The cost-effectiveness of the trial intervention by combining clinical data, quality of life data and healthcare utilisation data collected within the trial, and unit costs for participating countries that will stem from external sources. Extrapolation beyond 12 months may be performed to cover longer term effects of the intervention. 2, 6, and 12 months after inclusion: - Degree of polypharmacy, defined as the number of daily long-term medications - Quality of life as measured by the 5-level version of the European Quality of Life-5 Dimensions questionnaire (EQ-5D) - Pain/discomfort (EQ-5D) - Basic Activities of Daily Living (ADL) 2 and 12 months after inclusion: - Drug compliance as measured by Medication Adherence Questionnaire (MAQ) developed by Morisky with the addition of one question based on Gehi et al. (“In the past month, how | — |
Contacts
Public ContactC.J.A. (Lianne) Huibers
Heidelberglaan 100
Outcome results
None listed