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Minimising the Functional Burden of Medications in Older Inpatients: Implementation of the Drug Burden Index

Minimising the Functional Burden of Medications in Older Inpatients: Implementation of the Drug Burden Index

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12617000765325
Enrollment
253
Registered
2017-05-24
Start date
2016-04-12
Completion date
2016-11-11
Last updated
2017-06-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Older people in hospital are commonly prescribed multiple medicines, some that may cause side effects such as drowsiness, confusion, dry eyes. dry mouth, constipation and falls. The Drug Burden Index (DBI) is used to find out if the medications being prescribed might impact on a person's day-to-day activities. It takes into account all the medications that someone is using; in particular the medicines that cause sleepiness and side effects like dry mouth and confusion. If someone has a high score on the DBI, there is a higher risk of falls, frailty, hospitalisation, more visits to their local doctor, and overall poorer outcomes. We hypothesise that there is a missed opportunity in hospital to identify and reduce the burden of medications in older people which can be addressed using the DBI. The primary purpose of this study is to find out what happens in hospital when the pharmacist provides a report on the DBI to a patient's treating doctors, mainly to see if the report changes the medicines that the doctors prescribe. We will also look at patients' outcomes, like falls and repeat hospital visits, as well as ask staff and patients for their opinions of the report.

Interventions

Screen all patients aged over 70 years admitted to medical service or orthogeriatric service at Royal North Shore Hospital over a period of 7 months (time period study research pharmacist hired full time) and calculate Drug Burden Index (DBI) (exposure to medicines with anticholinergic and sedative effects). The DBI will be calculated online using a DBI calculator (www.drugburdenindex.com) that was developed by Professor Hilmer and Lisa Kouladjian. This has been shown to be a reliable and vali

Screen all patients aged over 70 years admitted to medical service or orthogeriatric service at Royal North Shore Hospital over a period of 7 months (time period study research pharmacist hired full time) and calculate Drug Burden Index (DBI) (exposure to medicines with anticholinergic and sedative effects). The DBI will be calculated online using a DBI calculator (www.drugburdenindex.com) that was developed by Professor Hilmer and Lisa Kouladjian. This has been shown to be a reliable and validated computerised clinical decision support system to report DBI of older patients taking multiple medications. This website is designed for 400 subjects and involves, under a unique code, entering the patient's medications, automatically calculating their DBI score, and the option to generate a PDF report. This PDF will then modified by the pharmacist to add in their recommendations. The pharmacist formulated these recommendations based on algorithms for withdrawing medications published on www.deprescribing.org, and a combination of resources that outline withdrawal sedative medications including Therapeutic Guidelines, Australian Medicines Handbook and the National Prescribing Service. Where the pharmacist was unsure of a recommendation, the advice of a geriatrician/clinical pharmacologist (Professor Hilmer) was sought. Those with DBI>0 who are likely to remain in hospital for a further 48 hours are eligible to participate. Obtain consent from patient/caregiver. Obtain baseline data on demographics, current medicines, diagnoses, functional status, falls, frailty, hospitalisations in previous year and self-reported health status. Randomise to control (usual care) or intervention Intervention: Pharmacist generates a report on DBI at baseline, highlighting contributing medicines and impact on function. DBI is calculated as soon as possible after admission i.e. after consent is obtained. Where possible, DBI should be calculated and the report generated within 48 hours of the patient's admission. Pharmacist will then discuss this report with the patient's treating team’s registrar and/or consultant, who will decide whether to make any changes to medicines (at their own discretion). They can choose to agree/disagree with the recommendations. The report is designed in such a way that one column has "pharmacists recommendations" and the adjacent column has "medical officer comments." This discussion should take place within 48 hours to allow time for the treating team to accept any recommendations and for these changes to take place whilst the patient is in hospital. After discussion, the pharmacist will document in the "medical officer comments" section whether they agreed or disagreed with the recommendation. If the recommendations are not viewed as a priority to the treating team on admission, where appropriate the pharmacist can discuss these recommendations again on discharge. Intervention adherence and fidelity are recorded by the research pharmacist through the DBI calculator software and the data collection sheets. Follow up data at 3 and 6 months from discharge date by phone call to patient/carer and/or GP and medical records. Information on medicines, physical function, falls, readmission, institutionalisation and mortality to be collected.

Sponsors

Royal North Shore Hospital
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Investigator)

Eligibility

Sex/Gender
All
Age
70 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Male and female patients aged 70 years or older Admitted to a service within the division of medicine or the orthogeriatric service during the study period Expected to remain in hospital for at least 48 hours after recruitment Informed consent can be obtained from patient or a person responsible Taking at least one regular anticholinergic or sedative medicine on admission, i.e. DBI >0 Able to communicate in English (or a translator is available)

Exclusion criteria

Patients in terminal phase of illness who are expected to die during current admission (as documented in the medical notes available on the ward)

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 28, 2026