Optimizing PharmacoTherapy In the Multimorbid Elderly in Primary CAre: the OPTICA Trial

University of Bern323 enrolled

Overview

The objective of this randomized controlled trial (RCT) is to evaluate whether the Systematic Tool to Reduce Inappropriate Prescribing (STRIP), put into practice through the STRIP Assistant (STRIPA) and implemented by general practitioners (GPs), will lead to an improvement in clinical and economic outcomes in patients aged 65 or older with multimorbidity and polypharmacy.

Background: Policy makers face many challenges, when they plan health care systems to meet the needs of the fast growing elderly population. More than 60% of the elderly suffer from multiple chronic conditions (multimorbidity - commonly defined as ≥3 chronic diseases) and get multiple drugs (polypharmacy - commonly defined as ≥5 regular medications). Multimorbid patients are often excluded from randomized controlled trials (RCT) and consequently most prescribing guidelines address diseases in isolation. Consequently, there is inappropriate prescribing, which results in diminished health states and lower quality of life of the patients. Older patients usually rely on their general practitioners (GPs) to manage their medications. However, GPs often have limited time to adapt polypharmacy. Reviewing medications and understanding their interactions based on a list of diagnoses and drugs is complex and time consuming. Furthermore, due to the increase of patients with multimorbidity and polypharmacy, medication review especially in patients with many drugs is often neglected. Pilot data from the Netherlands showed that a software-assisted method, called STRIPA, was effective for optimizing pharmacotherapy in primary care. Through the OPTICA trial this tool will now be tested in the Swiss primary care context. Study design: The OPTICA trial is a single-site cluster randomized controlled trial (RCT), which will be conducted at the Institute for Primary Health Care of the University of Bern (BIHAM). All study-related tasks will be performed centrally at the BIHAM except for patient recruitment and use of the STRIPA, as these two tasks will be performed in participating GP offices. The GPs in the intervention group use the STRIP assistant, whereas the GPs in the control group conduct a sham intervention: usual medication review and shared-decision making with patient. STRIPA is designed to optimize drug therapy and to advise on safe and appropriate therapy using STOPP/START criteria (STOPP = 'screening tool of older people's prescriptions'; START = 'screening tool to alert to right treatment'). Patients will be followed for 1 year with follow-up phone calls after 6 and 12 months. Study objectives: The primary objective of this study is to assess the effect of pharmacotherapy optimization through STRIPA on the medication appropriateness, which is measured by the medication appropriateness index (MAI) for drug overuse and by the assessment of underutilization (AOU) for drug underuse. The secondary objective of the OPTICA study is to assess the impact of pharmacotherapy optimization by STRIPA on the parameters listed below (1- 4) as well as to examine the use of the STRIP assistant by GPs (5) and to examine patients' willingness to deprescribe (6): 1. Degree of polypharmacy 2. Degree of over- and underprescribing 3. Number of falls and fractures 4. Quality of life, including pain/discomfort 5. Health economic parameters, including direct costs of the intervention and incremental cost-effectiveness 6. Enablers and barriers faced by GPs when using the STRIP assistant 7. Patients' willingness to deprescribe Statistical considerations: 40 clusters with a cluster size of 8-10 patients will be included. 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. There will be two co-primary outcomes, the improvement in the MAI score at 12 months, defined as decrease of the score of at least one point, and improvement in the AOU index at 12 months, defined as a reduction of at least one prescribing omission. Both outcomes will be tested separately and success claimed if either test is significant. Adjustment for multiple testing will be performed. In the primary analysis, the investigators will assess outcomes at the patient level, accounting for the correlated nature of data among GPs by using multilevel mixed-effects models. For the co-primary outcomes, the investigators will present and compare the proportion of patients with improvement of the MAI score and AOU index in the control and intervention groups. The relative difference between groups will be assessed using a mixed-effects logistic model with a random intercept at the GP level in order to account for clustering. Secondary binary outcomes will be evaluated like the primary outcomes. Secondary continuous outcomes will be analyzed using random-effects linear regression with a random intercept at the GP level. Models will additionally be adjusted for the baseline value as a covariate. Secondary count outcomes will be analyzed using random-effects Poisson regression with a random intercept at the GP level. Health economic analyses will comprise the assessment i) of resource use and cost differences between the trial arms, ii) the assessment of differences in quality-adjusted lifetime between the trial arms (expressed as quality-adjusted life years \[QALYs\]), and iii) the assessment of the cost-effectiveness of the intervention in comparison with the comparator, i.e. medication review in accordance with standard care.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

TRIPLE

Enrollment

323

Conditions

Multimorbidity Polypharmacy

Interventions

STRIPA interventionDEVICE

STRIPA is a Dutch software-based tool for the support of the pharmaceutical analysis by 1) taking into account the predictable adverse medication effects, 2) advising safe and appropriate therapy using established STOPP/START criteria, 3) interaction monitoring, and 4) appropriate dosing in accordance with renal function. It represents a highly efficient and user-friendly software engine, which is capable of individually screening the clinical status and pharmacological therapy of older patients with multimorbidity, which can define optimal drug therapy, and which can highlight the adverse drug reaction risk. A summary of these outputs will be used as STRIPA recommendations, which will, if applicable, be implemented by GPs and patients. Prior to the STRIPA medication review, the necessary patient information will be loaded from the FIRE database that contains data from more than 300 Swiss GP practices.

Sham interventionOTHER

Patients being assigned to the control arm will be treated in accordance with standard care. They will receive a sham intervention, which consists of a usual medication review by their GP and a shared decision making between patient and GP.

Eligibility

Sex: ALLMin age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria * Being a regular patient of participating GP * Age: 65 years of age or older * Multimorbidity: 3 or more coexistent chronic conditions defined by 3 distinct International Classification in Primary Care -2 (ICPC-2) codes defined as chronic (O'Halloran et al., 2004) with an estimated duration of 6 months or more, or based on a clinical decision supported by Pharmacost Groups (PCG) for chronic conditions in an algorithm from FIRE * Polypharmacy: Use of five or more different regular drugs (defined as authorized medications with registration numbers) for more than 30 days before signing the informed consent form Exclusion Criteria * Inability to provide informed consent from a patient or to obtain informed consent from a proxy for patients with cognitive impairment * If the patient is already participating in the a different interventional study

Locations (1)

Berner Institut für Hausarztmedizin, BIHAM

Bern, Switzerland

Outcomes

Primary Outcomes

Patients' medication appropriateness, as measured by two complementary co-primary outcomes: Co-primary outcome #1: change in the Medication Appropriateness Index (MAI)

Medication Appropriateness Index (MAI), assessed at baseline as well as at the 6 and 12 months follow-ups for each chronic medication of the patient. The 10 item version of the MAI will be used, but the cost-effectiveness item will be excluded. The MAI score for each medication will range from 0 to 17.

Time frame: 12 months

Patients' medication appropriateness, as measured by two complementary co-primary outcomes: Co-primary outcome #2: change in the Assessment of Underutilization (AOU)

Assessment of Underutilization (AOU), assessed for each of the patients' chronic conditions at baseline as well as at the 6 and 12 months follow-ups. For each chronic condition of the patient, the assessors decided whether there is i) no omission, ii) marginal omission, or iii) omission of indicated medication.

Time frame: 12 months

Secondary Outcomes

Patients' degree of polypharmacy

Numbers of regular long-term medications taken by patients, assessed at baseline as well as the 6 and 12 months follow-ups.

Time frame: 12 months

Patients' degree of overprescribing, as measured by the Medication Appropriateness Index (MAI)

The degree of overprescribing be assessed at baseline as well as at the 6 and 12 months follow-ups. The 10 item version of the MAI will be used. The MAI score for each medication will range from 0 to 18.

Time frame: 12 months

Patients' degree of underprescribing, as measured by the Assessment of Underutilization

The degree of underprescribing will be assessed at baseline as well as at the 6 and 12 months follow-ups. For each chronic condition of the patient, the assessors decided whether there is i) no omission, ii) marginal omission, or iii) omission of indicated medication.

Data from ClinicalTrials.gov

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