- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02317666
DBI - Tool for Medication Reviews in Older People
November 5, 2015 updated by: Katja Taxis, University of Groningen
Decreasing the Load? The Drug Burden Index - A Tool for Medication Reviews in Older People (the DBI TMO Study)
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
157
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Groningen, Netherlands, PO Box 72 9700 AB
- University of Groningen
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years and older (OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Medication Review
Structured 5-step multidisciplinary medication review (STRIP method) performed by the pharmacist in collaboration with the general practitioner.
|
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
|
NO_INTERVENTION: Delayed Medication Review
Patients in the control group will not undergo a medication review during the study period (delayed medication review).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
DBI decrease
Time Frame: 3 months
|
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
Time Frame: 3 months
|
Anticholinergic side effects, measured by the UKU side effect rating scale
|
3 months
|
Sedating side effects
Time Frame: 3 months
|
Sedating side effects measured by a validated patient-reported adverse drug event questionnaire
|
3 months
|
Risk of falls
Time Frame: 3 months
|
Risk of falls, measured by patients reports fall incidents and the "Up & Go" test to measure a patient's mobility
|
3 months
|
Cognitive Function
Time Frame: 3 months
|
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
Time Frame: 3 months
|
Assessed with the Groningen Activities Restriction Scale [Dutch: Groningen Activiteiten Restrictie Schaal]
|
3 months
|
Quality of Life
Time Frame: 3 months
|
as measured with the EQ-5D-3L
|
3 months
|
Hospitalisation
Time Frame: 3 months
|
Incident hospital admission inferred from patients' medical records
|
3 months
|
Mortality
Time Frame: 3 months
|
Incident mortality inferred from patients' medical records
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Katja Taxis, PhD, University of Groningen
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- van der Meer HG, Wouters H, Pont LG, Taxis K. Reducing the anticholinergic and sedative load in older patients on polypharmacy by pharmacist-led medication review: a randomised controlled trial. BMJ Open. 2018 Jul 19;8(7):e019042. doi: 10.1136/bmjopen-2017-019042.
- van der Meer HG, Wouters H, van Hulten R, Pras N, Taxis K. Decreasing the load? Is a Multidisciplinary Multistep Medication Review in older people an effective intervention to reduce a patient's Drug Burden Index? Protocol of a randomised controlled trial. BMJ Open. 2015 Dec 23;5(12):e009213. doi: 10.1136/bmjopen-2015-009213.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2014
Primary Completion (ACTUAL)
October 1, 2015
Study Completion (ACTUAL)
October 1, 2015
Study Registration Dates
First Submitted
December 11, 2014
First Submitted That Met QC Criteria
December 15, 2014
First Posted (ESTIMATE)
December 16, 2014
Study Record Updates
Last Update Posted (ESTIMATE)
November 6, 2015
Last Update Submitted That Met QC Criteria
November 5, 2015
Last Verified
November 1, 2015
More Information
Terms related to this study
Other Study ID Numbers
- the DBI TMO Study
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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