DBI - Tool for Medication Reviews in Older People

Polypharmacy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02317666
• Other study ID #: the DBI TMO Study
• Status: Completed
• Phase: N/A
• First received: December 11, 2014
• Last updated: November 5, 2015
• Start date: December 2014
• Est. completion date: October 2015

Study information

• Verified date: November 2015
• Source: University of Groningen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 157
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Cholinergic Antagonists
• Polypharmacy

Intervention

Procedure:
• Medication 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

Locations

Country	Name	City	State
Netherlands	University of Groningen	Groningen

Sponsors (1)

Lead Sponsor	Collaborator
University of Groningen

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Anticholinergic side effects	Anticholinergic side effects, measured by the UKU side effect rating scale	3 months	No
Secondary	Sedating side effects	Sedating side effects measured by a validated patient-reported adverse drug event questionnaire	3 months	No
Secondary	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	Yes
Secondary	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	No
Secondary	Activities of Daily Living	Assessed with the Groningen Activities Restriction Scale [Dutch: Groningen Activiteiten Restrictie Schaal]	3 months	No
Secondary	Quality of Life	as measured with the EQ-5D-3L	3 months	No
Secondary	Hospitalisation	Incident hospital admission inferred from patients' medical records	3 months	Yes
Secondary	Mortality	Incident mortality inferred from patients' medical records	3 months	Yes