PolypharmacyNCT02317666
DBI - Tool for Medication Reviews in Older People
A study testing Medication Review in people with Polypharmacy and Cholinergic Antagonists, run by University of Groningen at 1 site in Netherlands.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Polypharmacy, Cholinergic Antagonists
- What is being tested?
- Medication Review
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 157 participants
- Where
- 1 siteNetherlands
- Study dates
- Dec 2014to Oct 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- age ≥ 65,
- living independently,
- polypharmacy (≥ 5 medications),
- Drug Burden Index ≥ 1
- written informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
University of Groningen
Groningen, Provincie Groningen, PO Box 72 9700 AB
About this study
Official title: 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.
Read the 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.
- Conditions
- Polypharmacy, Cholinergic Antagonists
- Being tested
- Medication Review
- Keywords
- polypharmacy, drug burden index, aged, medication review, cholinergic agents
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medication ReviewProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| Medication Review | Experimental | Structured 5-step multidisciplinary medication review (STRIP method) performed by the pharmacist in collaboration with the general practitioner. Receives: Procedure: Medication Review |
| Delayed Medication Review | No intervention | Patients in the control group will not undergo a medication review during the study period (delayed medication review). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (8)
Anticholinergic side effects
Anticholinergic side effects, measured by the UKU side effect rating scale
Measured: 3 months
Sedating side effects
Sedating side effects measured by a validated patient-reported adverse drug event questionnaire
Measured: 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
Measured: 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
Measured: 3 months
Activities of Daily Living
Assessed with the Groningen Activities Restriction Scale [Dutch: Groningen Activiteiten Restrictie Schaal]
Measured: 3 months
Quality of Life
as measured with the EQ-5D-3L
Measured: 3 months
Hospitalisation
Incident hospital admission inferred from patients' medical records
Measured: 3 months
Mortality
Incident mortality inferred from patients' medical records
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2014 (estimated)
- Study startDec 2014
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PolypharmacyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 157 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Katja Taxis, University of Groningen
- Investigators
- Katja Taxis, PhD, Principal investigator, University of Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02317666
- Sponsor's protocol ID
- the DBI TMO Study
- Status last verified
- Nov 2015
- First submitted
- 11 Dec 2014
- Last updated
- 6 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 30030308van 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.
PubMed 26700279
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Decreasing the Load? The Drug Burden Index - A Tool for Medication Reviews in Older People (the DBI TMO Study)
- ClinicalTrials.gov ID
- NCT02317666
- Acronym / sponsor ID
- the DBI TMO Study
- Conditions
- Polypharmacy, Cholinergic Antagonists
- Keywords
- polypharmacy, drug burden index, aged, medication review, cholinergic agents
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 157 participants (actual)
- Lead sponsor
- University of GroningenUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 16 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Medication Review | Experimental | Procedure: Medication ReviewStructured 5-step multidisciplinary medication review (STRIP method) performed by the pharmacist in collaboration with the general practitioner. |
| Delayed Medication Review | No intervention | –Patients in the control group will not undergo a medication review during the study period (delayed medication review). |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- age ≥ 65,
- living independently,
- polypharmacy (≥ 5 medications),
- Drug Burden Index ≥ 1
- written informed consent
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medication ReviewA 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 | Procedure or surgery | Medication Review |
Primary outcome
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.
8 secondary outcomes
Anticholinergic side effects
Time frame: 3 months
Sedating side effects
Time frame: 3 months
Risk of falls
Time frame: 3 months
Cognitive Function
Time frame: 3 months
Activities of Daily Living
Time frame: 3 months
Quality of Life
Time frame: 3 months
Hospitalisation
Time frame: 3 months
Mortality
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2015.
- Derived from this study: PubMed 30030308van 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.
- Derived from this study: PubMed 26700279van 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katja Taxis, PhD principal investigator
University of Groningen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medication Review in people with Polypharmacy and Cholinergic Antagonists, run by University of Groningen at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DBI decrease (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02317666, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2015.