DBI - Tool for Medication Reviews in Older People

Study Overview
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Brief Summary
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Older people often use medications with anticholinergic or sedative side effects which increase the risk of falling, fractures caused by falls and cognitive impairment. In the Netherlands, medication reviews are done by pharmacists in collaboration with the general practitioner to optimize medication use and reduce these adverse drug events. To maximize the benefits of medication reviews it is helpful to identify patients with high risk medication, yet few appropriate tools are available The Drug Burden Index (DBI) designed in Australia, calculates anticholinergic and sedative drug burden. This study evaluates whether the DBI can be used to identify patients with anticholinergic and sedative medication in need of a medication review. A clustered randomized controlled intervention study will be conducted. Per pharmacy (cluster), one pharmacist will perform the medication reviews. In each pharmacy, one half of eligible patients will be randomly allocated to the control group and the other half in the intervention group. Data will be collected at baseline and at follow-up, 3 months after the medication review has taken place. The study population includes community-dwelling patients aged ≥ 65, with polypharmacy (≥ 5 medications) and a DBI value ≥ 1 (n = 190) selected by 10 community pharmacists. The intervention consists of a structured 5-step multidisciplinary medication review (STRIP method) as described in the multidisciplinary guidelines of Dutch General Practitioners performed by the pharmacist in collaboration with the general practitioner. The main endpoint is the difference in proportion of patients having a decrease of the DBI ≥ 0.5 between the intervention and control group at 3 months follow up. Secondary outcomes are anticholinergic side effects, risk of falls, cognitive function, function of daily activity, hospital admission and mortality. All participants will be informed about the study and asked to provide informed consent. Data will be processed confidentially. Only the researcher will have access to the data. If required, the Dutch Inspection of Healthcare will also be granted access to the data for Inspection. The burden of patients will be kept at a minimum by trying to retrieve as much information as possible from patient's medical records and by using questionnaires and tests that were specifically developed for this population. In the investigators opinion, participation does not involve risks.

Detailed Description
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Older people often use medications with anticholinergic or sedative side effects which increase the risk of falling, fractures caused by falls and cognitive impairment. In the Netherlands medication reviews are done by pharmacists in collaboration with the general practitioner to optimize the medication use and reduce these adverse drug events. To maximize the benefits of medication reviews it is helpful to identify patients with high risk medication, yet there are few tools to identify patients in need of a medication review. The Drug Burden Index (DBI) is a tool, designed in Australia, that calculates the burden of anticholinergic and sedative medications, taking into account a patient's dose. The DBI could be a useful tool to identify high risk patients who could benefit from medication reviews. The objective of this study is to evaluate whether the DBI can be used as a tool to identify patients with anticholinergic/sedative medication in need of a medication review. A single blinded clustered randomized controlled intervention study. Every pharmacy forms a cluster and per pharmacy one pharmacist will perform the medication reviews. In each pharmacy, one half of eligible patients will be randomly allocated to the control group and the other half in the intervention group. There are two measurements: at baseline and at follow-up, 3 months after the medication review has taken place. The study population includes community-dwelling patients aged ≥ 65, with polypharmacy (≥ 5 medications) and a DBI value ≥ 1 (n = 190) selected by 10 community pharmacists. The intervention consists a structured 5-step multidisciplinary medication review (STRIP method) as described in the multidisciplinary guidelines of the Dutch General Practitioners Society (Nederlands Huisartsen Genootschap, 2013) including the objective to reduce the DBI, performed by the pharmacist in collaboration with the general practitioner. The main endpoint is the difference in proportion of patients having a decrease of DBI ≥ 0.5 between the intervention and control group at follow up (3 months later). Secondary outcomes are the difference in proportion of patients having a DBI <1 between the intervention and control group at follow up (3 months later), the anticholinergic side effects, risk of falls, cognitive function, function of daily activity, hospital admission and mortality. All participants will be informed about the study. Informed consent will be asked from every participant. Data will be processed anonymously. Only the researcher will have access to the data. If required, the Dutch Inspection of Healthcare will also be granted access to the data for Inspection. The burden of patients will be kept at a minimum by trying to retrieve as much information as possible from patient's medical records and by using questionnaires and tests that were specifically developed for this population. In the investigators opinion, participation does not involve risks.

Official Title
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Decreasing the Load? The Drug Burden Index - A Tool for Medication Reviews in Older People (the DBI TMO Study)

Conditions
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Polypharmacy, Cholinergic Antagonists

Intervention / Treatment
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* Procedure: Medication Review


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age ≥ 65, living independently, polypharmacy (≥ 5 medications), Drug Burden Index ≥ 1 written informed consent Exclusion Criteria: patients who have a limited life expectancy (<3 months) patients who urgently need a medication review and for whom postponing a medication review is unethical insufficient command of the Dutch language patients with advanced dementia. patients who received a medication review < 9 months before recruitment date

Ages Eligible for Study
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Minimum Age: 65 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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Medication Review<br>Structured 5-step multidisciplinary medication review (STRIP method) performed by the pharmacist in collaboration with the general practitioner. | Procedure: Medication Review<br>* A structured 5-step multidisciplinary medication review (STRIP method) as described in the multidisciplinary guidelines by the Nederlands Huisartsen Genootschap (2013) including the objective to reduce the DBI, performed by the pharmacist in collaboration with the general practitioner<br>|
| No Intervention: Delayed Medication Review<br>Patients in the control group will not undergo a medication review during the study period (delayed medication review). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DBI decrease | The primary outcome is the difference in proportion of patients having a decrease of DBI ≥ 0.5 between the intervention and control group at follow-up. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anticholinergic side effects | Anticholinergic side effects, measured by the UKU side effect rating scale | 3 months | 
| Sedating side effects | Sedating side effects measured by a validated patient-reported adverse drug event questionnaire | 3 months | 
| Risk of falls | Risk of falls, measured by patients reports fall incidents and the Up & Go test to measure a patient's mobility | 3 months | 
| Cognitive Function | Cognitive function, measured by the Seven Minute Screen, the Trailmaking Test A & B and the Digit Symbol Coding Test of the Wechsler Adult Intelligence Scale III | 3 months | 
| Activities of Daily Living | Assessed with the Groningen Activities Restriction Scale [Dutch: Groningen Activiteiten Restrictie Schaal] | 3 months | 
| Quality of Life | as measured with the EQ-5D-3L | 3 months | 
| Hospitalisation | Incident hospital admission inferred from patients' medical records | 3 months | 
| Mortality | Incident mortality inferred from patients' medical records | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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polypharmacy, drug burden index, aged, medication review, cholinergic agents