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DBI - Tool for Medication Reviews in Older People

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02317666
Enrollment
157
Registered
2014-12-16
Start date
2014-12-31
Completion date
2015-10-31
Last updated
2015-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cholinergic Antagonists, Polypharmacy

Keywords

polypharmacy, drug burden index, aged, medication review, cholinergic agents

Brief summary

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

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.

Interventions

PROCEDUREMedication Review

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

Sponsors

University of Groningen
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
DBI decrease3 monthsThe 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.

Secondary

MeasureTime frameDescription
Sedating side effects3 monthsSedating side effects measured by a validated patient-reported adverse drug event questionnaire
Risk of falls3 monthsRisk of falls, measured by patients reports fall incidents and the Up & Go test to measure a patient's mobility
Cognitive Function3 monthsCognitive 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
Anticholinergic side effects3 monthsAnticholinergic side effects, measured by the UKU side effect rating scale
Quality of Life3 monthsas measured with the EQ-5D-3L
Hospitalisation3 monthsIncident hospital admission inferred from patients' medical records
Mortality3 monthsIncident mortality inferred from patients' medical records
Activities of Daily Living3 monthsAssessed with the Groningen Activities Restriction Scale \[Dutch: Groningen Activiteiten Restrictie Schaal\]

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 3, 2026