DBI - Tool for Medication Reviews in Older People

NCT02317666 | Completed

• 1 other identifier: the DBI TMO Study
• Study Type: interventional
• Target: 157
• Locations: 1 country
• Sites: 1

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.

Conditions

Polypharmacy; Cholinergic Antagonists

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Anticholinergic side effects

  3 months

• Sedating side effects

  3 months

• Risk of falls

  3 months

• Cognitive Function

  3 months

• Activities of Daily Living

  3 months

Study Arms (2)

Medication Review

EXPERIMENTAL

Structured 5-step multidisciplinary medication review (STRIP method) performed by the pharmacist in collaboration with the general practitioner.

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).

Interventions

Medication Review PROCEDURE

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

Medication Review

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• age ≥ 65,
• living independently,
• polypharmacy (≥ 5 medications),
• Drug Burden Index ≥ 1
• written informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Groningen: lead

Study Sites (1)

University of Groningen

Groningen, Provincie Groningen, PO Box 72 9700 AB, Netherlands

Location

Related Publications (2)

• 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.

  PMID: 30030308 DERIVED

• 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.

  PMID: 26700279 DERIVED

MeSH Terms

Interventions

Medication Review

Intervention Hierarchy (Ancestors)

Medication Systems; Organization and Administration; Health Services Administration; Patient Care Management

Study Officials

• Katja Taxis, PhD

  University of Groningen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pharmacotherapy and Clinical Pharmacy

Study Record Dates

• First Submitted: December 11, 2014
• First Posted: December 16, 2014
• Study Start: December 1, 2014
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: November 6, 2015

Record last verified: 2015-11

Locations

NL (1)