None listed
Conditions
Brief summary
Medication-related problems are common after hospital admissions. Medication reviews are an established service, funded by the Australian Government for over 20 years, to help people to get the most benefit from their medicines and reduce their chance of experiencing harm from them. Currently, there is no system in place to ensure that this service is routinely offered to people at risk of medication harm when they leave hospital. The aim of the trial is to investigate whether an implementation model for improving access to a timely post-discharge medication review reduces 90-day readmissions. The trial will use a stepped-wedge cluster randomised design involving four centres (one per cluster), each consisting of a hospital and associated Primary Health Network (PHN). Three centres are in New South Wales and one is in Queensland. Patient participants will be recruited over a 24-month period from February 2023 to January 2025. The model will be co-adapted to suit local circumstances with the involvement of local hospital and primary care healthcare practitioners and consumers. Core features of the model will include: (1) a hospital-based pharmacist or nurse responsible for identifying patients likely to benefit from a medication review; (2) implementation of a PHN-based Medication Safety Hub with a dedicated Medication Safety Pharmacist to coordinate the medication review and other medication safety initiatives in the PHN; (3) Communication channels for medication safety oversight between hospitals and primary care; (4) PHN-led multi-disciplinary continuing professional development events on medication safety for local hospital and primary care healthcare practitioners (5) A communication strategy to raise awareness of the new role of the PHN and importance of medication review after a hospital stay (6) Indicator development to support GPs identify patients who would benefit from a medication review, and to monitor uptake and effectiveness. Data collected from participants in the trial will be linked with hospitalisations and Medicare data to measure outcomes, including readmissions, emergency presentations and healthcare utilisation.
Interventions
The intervention is a systems-based collaborative model to improve timely access to, and enhance the effectiveness of, the existing government-funded medication review services for people at risk of medication harm after a hospital stay. The medication review services include Home Medicines Review (HMR) and Residential Medication Management Review (RMMR), which are funded by the Australian Government and provided by GPs and accredited pharmacists.
The model is targeted at the local health syst
The intervention is a systems-based collaborative model to improve timely access to, and enhance the effectiveness of, the existing government-funded medication review services for people at risk of medication harm after a hospital stay. The medication review services include Home Medicines Review (HMR) and Residential Medication Management Review (RMMR), which are funded by the Australian Government and provided by GPs and accredited pharmacists. The model is targeted at the local health system level. Co-adaptation workshops will be held at each centre involving hospital and primary care healthcare practitioners and consumers to tailor the intervention to suit local systems and resources. The trial has a stepped wedge randomised cluster design with four trial centres (‘clusters’), each consisting of a hospital and associated primary healthcare network (PHN). Patient participants aged 45 years and over who at high risk of medication harm according to a screening tool and clinical assessment, will be recruited at the hospitals within 72 hours of their anticipated discharge date, over a 24-month period. The total trial duration is 27 months. Trial centres will provide usual care (comparator treatment) until the time at which they have been randomised to start the intervention. The control phase at each centre will be 5, 9, 13 or 17 months in duration, depending on the random allocation of the centre. There will be a 2-month transition phase (lead-in period) to embed the intervention; data collected from this period will be excluded from the analysis. During the control phase, coadaptation workshops will be held at each centre with local healthcare practitioners and other stakeholders to identify local systems (e.g. information transfer, communication preferences) and adaptations required to implement the intervention at that centre. Participants will be blinded to the phase of the trial, but healthcare practitioners and researchers will not. PHNs are independent organisations funded by the Australian Government to coordinate primary healthcare in a region. There are five core components of the intervention, which are designed to address both the key limitations of the existing HMR and RMMR programs and the core contributors to post-discharge medication problems: 1. A research assistant (study pharmacist or study nurse) will be employed by, and located at, each hospital to identify people who may benefit from a post-discharge medication review, applying clinical judgement in consultation with the clinical team, and using a screening tool, developed specifically for this trial. The research assistant will apply the screening tool to pre-screen electronic medical records of patients anticipated to be discharged within the next 72 hours, and they will conduct a short patient interview (15 minutes) to verify eligibility against the tool. Audits of data entry against electronic medical records will be conducted by the study coordinator for random participant samples at trial commencement, at 10% participant accrual, 6-monthly and at the close of the trial. 2. A Medication Safety Hub (MSH) will be implemented in each PHN with an appointed Medication Safety Pharmacist to coordinate timely post-discharge medication review services. Patient participation in medication reviews will be derived from Medicare Benefits Schedule (MBS) claims data and verified by follow up participant telephone survey at 90 days. 3. Communication channels will be established between the PHN-based Medication Safety Pharmacist (MSP) and local hospital and primary care healthcare practitioners to support coordination of medication review services. MSP diaries and email records will be used to assess fidelity. 4. Multidisciplinary continuing professional development (CPD) events on quality use of medicines topics will be run by the PHN MSH for local hospital and primary care healthcare practitioners. The objective will be to foster a collaborative patient-centred approach to optimising medicines use and improving medication safety in the PHN and across transitions of care. GPs, junior medical officers, community pharmacists and hospital pharmacists will be invited to 60-to-90-minute events held at least every 8 weeks over the duration of the intervention phase. Events will have a case study format. Identification of appropriate quality indicators for GPs to help identify participants who may benefit from a medication review will also be covered. Topics will be informed by local needs, and the delivery mode (e.g. face-to-face, video-conferencing) suited to local preferences. The number of healthcare practitioners attending will be collected using session attendance lists. 5. A communication strategy will be implemented to raise awareness among local hospital and primary care healthcare practitioners of the new role of the PHN in coordinating medication reviews and medication safety initiatives, and the importance of timely post-discharge medication review. The strategy will be tailored to local needs and existing communication tools of the centre and developed during the co-adaptation workshops. Up to 72 hours before being discharged from hospital, a patient enrolled during the intervention phase of the study will: • Participate in a single 15-minute session in which the research assistant (study pharmacist or nurse) will provide oral and written information on medication review (ie, NPS Medicinewise Factsheet ‘How a medicine review in your home can help you get the most from your medicines’) and the opportunity to ask questions. The information will include what is a medication review, possible benefits, what’s involved (e.g. a 1-hour interview by a pharmacist), who can do a medication review, and cost. • Be encouraged by the research assistant (study pharmacist or nurse) to visit their GP soon after discharge (within the hospital’s recommended time), to take along their discharge summary letter, and to ask their GP about a medication review • Have the request for a medication review communicated separately to their GP (by phone or secure email) by the PHN Medication Safety Pharmacist They may also have their hospital clinical team include a written recommendation for a medication review in their discharge summary letter to their GP with any additional information to support a review. After arriving home, a patient enrolled during the intervention phase of the study may: • Be offered a medication review by their GP during their GP consultation. • Be referred by their GP to an accredited pharmacist for a medication review (HMR or RMMR). If referred, there may be a separate communication made on their behalf by the PHN Medication Safety Pharmacist to the accredited pharmacist with any additional information about the individual’s medicines to assist them carry out the HMR or RMMR. If offered a HMR or RMMR by their GP, a patient enrolled during the intervention phase of the study will receive a medication review in accordance with the existing HMR and RMMR program guidelines, and the usual practices of their GP and the accredited pharmacist. Key HMR/RMMR steps in the funded HMR and RMMR programs are: • The HMR or RMMR is conducted by a participating accredited pharmacist together with the patient (face-to-face, where possible) in their own home or at the residential aged care home. The pharmacist assists the risks and benefits of each medicine, the complexity of the regimen and how the patient is managing their medicines. They identify ways to improve the patient's adherence to their medicines, reduce medication error and resolve medicine-related problems, and they make recommendations to the patient's GP to reduce the risk of harm and optimise the benefit the patient receives from their medicines. • The accredited pharmacist provides a report of the HMR or RMMR with recommendations about ongoing therapy to the patient’s GP and community pharmacy. • The GP contacts the patient on receipt of the report and ask them to make an appointment. • The GP and the patient review the pharmacist’s report together at the GP's practice. Together they develop a medication management plan using the report as the basis, considering which, if any, recommendations should be acted on.
Sponsors
The University of Sydney
Study design
Allocation
Randomised controlled trial
Intervention model
Other
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
45 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Adult hospital in-patients who 1. Reside in the Primary Health Network of the hospital site. 2. Have a Medicare card 3 Have a nominated GP or nominated general practice in the Primary Health Network 4. Have a nominated community pharmacy in the Primary Health Network 5. Meet one or more of the following: i.) Admission is due to a medication-related problem (as recorded in patient’s notes or identified during ward round) ii.) Is taking 10 or more medicines (including PRN) iii.) Has been started on 1 or more high-risk medicines during admission iv.) Has had 4 or more changes made to medicines during admission v.) Has had 1 or more change to a high-risk medicine or to a falls risk increasing medicine during admission vi.) Is taking 2 or more falls risk increasing, anticholinergic or sedative medicines on discharge vii.) Has difficulty managing medicines, as assessed by patient, GP, medical team or pharmacist, due to 1 or more of: (a) literacy or language; (b) dexterity or vision or frailty or mobility; (c) cognitive impairment or confusion or dementia; or (d) access to medicines (e.g., financial) Definitions High risk medicines include but are not limited to insulins, anticoagulants, oral hypoglycaemics, dual antiplatelet therapy, digoxin, opioids, oral cytotoxics, sedatives, hypnotics, anxiolytics, antipsychotics, anticholinergic medicines Falls-risk increasing medicines include but are not limited to medicines listed in the NSW TAG Medication-related Falls Risk Assessment Tool. Anticholinergic medicines include but are not limited to medicines listed in 'Drugs with anticholinergic effects', Australian Medicines Handbook Sedative medicines include but are limited to medicines listed in 'Drugs for Anxiety and sleep disorders', Australian Medicines Handbook
Exclusion criteria
Individuals will be excluded if they 1. are younger than 45 years of age. 2. are receiving active radiation therapy or chemotherapy for malignant conditions 3. have been admitted for planned dialysis 4. are in terminal phase of palliative care 5. are unable to attend Medication Management Review within the time frame 6. have previously been recruited to ASPIRE trial 7. are being transferred to a rehabilitation, private or other hospital
Outcome results
None listed