Health Economic Evaluation Alongside the OPERAM Trial

Study Overview
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Brief Summary
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The objective of the health economic evaluation is to perform a state-of-the-art economic analysis of the STRIP intervention, alongside the OPERAM Randomised Controlled Trial (RCT).

Detailed Description
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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 (DRAs). 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, and are very costly. Public funds spent on prescription medicines are steadily increasing in many European countries. Under strained budget conditions, healthcare services need to show that they provide value for money, and thus detailed health economic evaluations have become essential for health budget planning. Some studies assessing the impact of medication optimising interventions have assessed the cost-effectiveness of such interventions. A recent Cochrane review looking at interventions to optimise prescribing for the older people in care homes found an unclear effect of interventions on drug costs (Alldred DP 2013). Further assessment of healthcare costs related to inappropriate medication and the cost-effectiveness of pharmacotherapy optimising solutions is essential for a better control of rapidly increasing health care costs. 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. Health economic data (covering medical resource use, the provision of informal care and health-related quality of life using the EQ-5D instrument) will be collected from enrolled patients at baseline and during the follow-up phone calls after 2, 6 and 12 months. Patients will be asked to complete a booklet serving as a memory aid. Where relevant, information can also be provided by proxy respondents (e.g. family members, primary care physicians). Additionally, staff time spent on the intervention and comparable activities in the comparator arm will be collected from site staff. Objectives: The objectives of the health-economic evaluation are to assess the impact of pharmacotherapy optimisation by the STRIP intervention on economic parameters, health care utilisation and preference-based quality of life. Statistical considerations: Over all sites, 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. Health economic analyses will comprise the assessment of cost differences between the trial arms, of differences in quality-adjusted lifetime between the trial arms (expressed as quality-adjusted life years), and of the incremental cost-effectiveness of the intervention in comparison with the comparator, i.e. standard care. Cost will be calculated by combining the healthcare resource utilisation observed in the trial with national unit costs from sources external to the trial. Health economic analyses involving costs are necessarily country-specific. It is planned to perform these analyses for at least two countries contributing patients to the OPERAM trial, which remain to be specified. This will involve the use of all or a subset of trial data (depending on the degree of heterogeneity observed between participating countries) in combination with a set of national unit costs and a national valuation algorithm for the EQ-5D. Perspectives of cost assessment remain to be decided. Typical perspectives are those of the healthcare system or a nationally relevant third party payer. All health economic analyses will be subjected to extensive sensitivity analyses to understand the robustness of the results given stochastic uncertainty inherent in the trial data and parameter uncertainty expected for the external unit cost data. Additionally, performance characteristics of the 5-level version (used in all patients) and the 3-level version (additionally administered in a subsample of 300 patients of the EQ-5D will be compared, e.g. in terms of discriminatory power, responsiveness to change over time and effect size.

Official Title
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Health Economic Evaluation Alongside the OPERAM Trial (OPtimising thERapy to Prevent Avoidable Hospital Admissions in the Multimorbid Older People: a Cluster Randomised Controlled Trial).

Conditions
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3 or More Chronic Conditions for 6 Months or Longer, 5 or More Regular Drugs

Intervention / Treatment
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* Other: STRIP intervention
* Other: Control


Participation Criteria
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Eligibility Criteria
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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. 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

Ages Eligible for Study
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Minimum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: STRIP intervention<br>The intervention will take place during the initial hospital admission (Index Hospitalisation) or an equivalent situation for outpatients. STRIP is a structured method to perform pharmacotherapy optimisation. The STRIP-intervention consists of 9 steps. | Other: STRIP intervention<br>* The STRIP intervention consists of 9 steps: 1. structured history taking of medication 2. recording medication and diagnoses in STRIPA 3. structured drug review based on the STRIPA with the integrated Screening Tool of Older Person's Prescriptions (STOPP)/ Screening Tool to Alert Doctors to the Right Treatment (START) criteria 4. communication and discussion of the structured drug review with prescribing physician with possible adaptation of the recommendation 5. shared decision-making with the patient with possible adaptation of the recommendation 6. optional revision based on new accumulating data during hospitalisation (e.g. new diagnoses, adverse drug reactions) 7. generation of general practioner (GP) report 8. delivery of the report to the patient and to the GP (optional additional direct communication) 9. follow-up<br>* Other names: Systematic drug review;|
| Sham Comparator: Control<br>Participants in the control group will receive medication review by the prescribing physicians in accordance with usual care. If an extended drug review is in place in a ward/specialty corresponding characteristics are collected on cluster level. | Other: Control<br>* Standard care in the department where the trial is conducted<br>* Other names: Standard care;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The cost-effectiveness of the STRIP intervention | The cost-effectiveness analysis (CEA) is performed 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. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Healthcare utilisation |  | 12 months | 
| Informal care received |  | 12 months | 
| Healthcare costs | Performed during the follow-up period, based on unit costs for participating countries that will stem from external sources | 12 months | 
| Quality of life EQ-5D | Measured by the 5-level version of the European Quality of Life-5 Dimensions questionnaire (EQ-5D) | 2, 6, and 12 months | 
| Direct costs of the STRIP intervention |  | during the index hospitalisation at baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Drug Utilization Review, Older people, Health economics