Skip to content

Preventing Adverse Drug Reactions in Older Australians

Prevention of Adverse Drug Reactions in Older Patients After Discharge Using a Pharmacist Intervention: A Randomized Controlled Trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12619000729123
Acronym
PADR-AD
Enrollment
28
Registered
2019-05-14
Start date
2020-03-03
Completion date
2021-03-02
Last updated
2020-11-09

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

Conditions

None listed

Brief summary

In Australians 65 years and older, 19% of hospital admissions to medical wards are associated with serious side-effects from medications. Almost 90% of these admissions are preventable through safer use of medicines. The research team have developed a novel method of identifying people at risk of these problems. In this study hospital pharmacists will assess the risk of serious side-effects in people admitted to hospital and make recommendations to reduce this risk to hospital staff, general practitioners and pharmacists. We will test whether this strategy reduces the risk of these events compared to standard care in the 12 months following hospital discharge. We hypothesize that ADR risk assessment on admission to hospital and communication of this risk, with recommendations that target the specific risk factors identified, will reduce the incidence of ADRs occurring during admission and in the 12-months post-discharge.

Interventions

We developed and validated a risk score (the PADR-EC score) for ADR-related hospitalization in older patients. We will conduct an open-label randomized controlled trial to investigate the effectiveness of an intervention to reduce the risk of ADRs during and following hospitalization compared to control. Patients 65 years or older who are admitted under the care of a medical team at the Royal Hobart Hospital will be approached to provide their consent. Their nominated general practice and commun

We developed and validated a risk score (the PADR-EC score) for ADR-related hospitalization in older patients. We will conduct an open-label randomized controlled trial to investigate the effectiveness of an intervention to reduce the risk of ADRs during and following hospitalization compared to control. Patients 65 years or older who are admitted under the care of a medical team at the Royal Hobart Hospital will be approached to provide their consent. Their nominated general practice and community pharmacy will also be provided with relevant information to enable follow up. All patients will undertake a comprehensive interview to establish their baseline risk of ADRs using an ADR risk score, and will then be randomized to the intervention or control group using a central randomization service. For intervention patients, in addition to usual care, a clinical pharmacist researcher will prepare a comprehensive ADR risk assessment and medication management plan based on the level of risk (low/moderate/high), which will be shared with the clinical team during the hospitalization to inform in-hospital care. The ADR risk assessment is done using the PADR-EC score. The PADR-EC score was developed based on ADR admissions to the hospital to identify people at high risk of ADRs and uses the risk factors of recent medication changes, inappropriate anticholinergic drugs, dementia, renal impairment, and multiple antihypertensives to categorize the risk of ADRs. The management plan includes considering the following factors that impact on the PADR-EC score and ADR risk • Recent medication changes • Renal impairment defined as eGFR less than 60mL/min • Dementia – is there a documented diagnosis in the notes? • Number of antihypertensives • Anticholinergic medications • Any other clinically relevant drug-related problems that could lead to ADRs This will also form a part of the discharge plan, which will be communicated to each intervention patient’s nominated GP and community pharmacy. The best possible medication history is collected from the patients and their relatives and/or caregivers, their general practitioner, and/or community pharmacy. The patients’ previous admission/discharge details are also stored as an electronic patient file or digital medical record, which could also be accessed during the study for any missing information.

Sponsors

Luke Bereznicki
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)

Eligibility

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

Inclusion criteria

Patients aged 65 years and older with an unplanned overnight admission to a medical ward in the Royal Hobart Hospital, Tasmania.

Exclusion criteria

Patients unwilling to consent to the study Patients unable to consent to the study with a consenting authority not present at the hospital Patients unable to be interviewed due to health reasons, with a consenting authority not present at the hospital Patients unavailable for follow-up Patients residing in, or being discharged to a nursing home Patients being transferred to a palliative care unit Medical notes not available Patients already enrolled in a post-discharge intervention

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026