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The Effects of an Intervention to Optimise Quality Use Of Medicines In Older People in Hospital

The Effects of an Intervention to Optimise Quality Use Of Medicines In Older People in Hospital - a stepped wedge randomised control trial with an embedded 12 week pre-trial data period

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12622000374763
Enrollment
171
Registered
2022-03-03
Start date
2022-04-19
Completion date
2023-07-04
Last updated
2026-01-05

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

Conditions

None listed

Brief summary

Polypharmacy is the use of five or more regular medicines. In some patients taking polypharmacy, the current risk of some of their medicines may outweigh the benefits. This is called ‘inappropriate polypharmacy’. We have developed several tools, presented as a bundle, to reduce inappropriate polypharmacy for inpatients. Using a stepped wedge randomised control trial, we aim to use these tools, supported by a stewardship pharmacist, to optimise medicines use in the hospital and improve outcomes for older people across six hospitals in Northern Sydney and Central Coast NSW. By later obtaining linked data from the Centre for Health Record Linkage, we will investigate whether the bundle can reduce hospital readmissions, Emergency Department presentations and mortality within 28 days and 12 months of the patients' baseline hospital stay. Additionally, we will investigate whether the bundle improves the patients' experience of medication review in hospital and their quality of life after hospital discharge.

Interventions

A multifaceted tool bundle including computerised decision support to measure exposure to medications with anticholinergic and sedative effects (Drug Burden Index [DBI]) in the electronic medical record (EMR) was developed to guide patient-centred medication review in older patients in hospital. The intervention is the combination of a DBI stewardship program with the multifaceted tool bundle that is available for use by the multidisciplinary team. The intervention includes: 1. Prioritise patie

A multifaceted tool bundle including computerised decision support to measure exposure to medications with anticholinergic and sedative effects (Drug Burden Index [DBI]) in the electronic medical record (EMR) was developed to guide patient-centred medication review in older patients in hospital. The intervention is the combination of a DBI stewardship program with the multifaceted tool bundle that is available for use by the multidisciplinary team. The intervention includes: 1. Prioritise patients for medication review based on Drug Burden Index score (DBI>0). The DBI Calculator in the EMR presents the patient’s DBI score on the patient’s EMR MPage and in the pharmacist’s patient list on the Pharmacy Care Organiser; 2. Support and guide medication review in hospital using: (i) The DBI EMR MPage, which provides detailed information on the patient’s DBI throughout the admission; (ii) Education and guides for clinicians and consumers (an eleven minute online video Health Education and Training Institute [HETI] Polypharmacy Module available to NSW Health staff via https://www.heti.nsw.gov.au/education-and-training/my-health-learning, online pdf clinician deprescribing guides and consumer deprescribing leaflets, developed in related project and available from https://www.nswtag.org.au/deprescribing-tools/); and (iii) Monitoring and feedback using NSW Therapeutic Advisory Group [TAG] Polypharmacy Quality Indicators developed in related project and available from https://www.nswtag.org.au/polypharmacy-qum-indicators-and-resources/ The Steward is a research pharmacist who will provide education on the bundle through usual professional development channels (departmental and hospital clinical meetings and continuing education meetings) for doctors, nurses and pharmacists at each site. The Steward will flag potential drugs to consider deprescribing in eligible patients to clinicians and provide support for clinicians when using the intervention materials (for example, twice weekly to daily telephone calls with the doctors, attendance at wards rounds and/or meetings related to patient care, and documentation of deprescribing recommendations in the hospital electronic medical record). The Steward’s workflow may vary slightly between sites as clinician input (including through Hospital Working Groups) on how to best integrate the Stewardship and the multifaceted bundle into their usual workflow will be sought, primarily in the last week of the control period and first week of the intervention period for each hospital site. Hospital Work Group membership will vary depending on each site, however, it is envisaged that each Group will consist of an Executive Sponsor, the Site Principal Investigator, the Director of Pharmacy (or delegate senior clinical pharmacist), the Steward and nominee senior and junior clinicians, clinical pharmacist and nursing staff from each target ward. The Steward may shadow Working Group members and/or their delegates to observe the workflow processes in target services and make notes on his/her observations. Prior to implementation of the bundle, all hospitals will receive standard pharmaceutical care in hospital. This should include medication reconciliation and medication review of patients perceived to be at high risk using local risk assessment strategies. Electronic medical record data will be collected for 12 weeks as pre-trial baseline data. After the 12 week pre-trial data period, the hospital sites will be randomised to commencing the DBI stewardship program at different times, with one hospital transitioning from the control (bundle only) to the intervention (DBI stewardship program and bundle) every 6 weeks in the stepped wedge trial period. The DBI Stewardship will begin as an intensive program for the first 12-week time block at each hospital site and then transition to a less intensive program to capture the sustainability of the DBI Stewardship in the remaining period of the stepped wedge trial period (12 to 42 weeks depending on when the hospital was randomised to start the DBI Stewardship Program). In the less intensive program, the Steward will shift focus from provision of patient-specific deprescribing recommendations to reminders about using the bundle. A purposely chosen cohort of participants who are representative of the variety of patients/carers, hospital clinicians and general practitioners will be recruited to participate in the mixed methods analysis (self-administered questionnaire and interview or focus group) to evaluate the enablers and barriers of the intervention.

Sponsors

Northern Sydney Local Health District
Lead SponsorGovernment body

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Educational / counselling / training
Masking
Open (masking not used)

Eligibility

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

Inclusion criteria

Stepped wedge randomised control trial: adults aged 65 years or older admitted to one of the six participating hospital sites for >=48 hours (and/or their carers), Mixed methods analysis: adults aged 65 years or older admitted to one of the six participating hospital sites for >=48 hours (and/or their carers), clinicians working in the target wards at one of the six participating hospital sites, GPs of the eligible patients DBI Stewardship: DBI score>0

Exclusion criteria

Stepped wedge randomised control trial: adults whose hospital admission <48 hours. DBI Stewardship: DBI score=0 Some individuals may not survive the index admission. However, this will not be applied as exclusion criteria because it may bias the study cohort to comprise of fitter individuals and reduce the representativeness of the hospital population. This can be managed by manually identifying the individuals who do not survive their initial hospital admission during the trial period and reporting this finding.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026