Ignite Creation Date:
2024-05-06 @ 3:31 AM
Last Modification Date:
2024-10-26 @ 11:35 AM
Study NCT ID:
NCT02317666
Status:
COMPLETED
Last Update Posted:
2015-11-06
First Post:
2014-12-11
Brief Title:
DBI - Tool for Medication Reviews in Older People
Sponsor:
University of Groningen
Organization:
University of Groningen
Study Overview
Official Title:
Decreasing the Load The Drug Burden Index - A Tool for Medication Reviews in Older People the DBI TMO Study
Status:
COMPLETED
Status Verified Date:
2015-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 05 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 patients 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 patients 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 anticholinergicsedative 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 05 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 patients 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None