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Trial registered on ANZCTR


Registration number
ACTRN12622000374763
Ethics application status
Approved
Date submitted
11/02/2022
Date registered
3/03/2022
Date last updated
27/07/2022
Date data sharing statement initially provided
3/03/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
The Effects of an Intervention to Optimise Quality Use Of Medicines In Older People in Hospital
Scientific title
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
Secondary ID [1] 306286 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Medication burden 325045 0
Condition category
Condition code
Public Health 322662 322662 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 322714 0
Other interventions
Comparator / control treatment
The control is the multifaceted tool bundle without the DBI Stewardship Program. The control period will last from 12 – 42 weeks depending on when the hospital site is randomised to transition to intervention.

Electronic medical record data will be collected for a further 12 weeks prior to switching on the multifaceted tool bundle (the start of the control period) for pre-trial baseline data.
Control group
Active

Outcomes
Primary outcome [1] 330266 0
Any reduction of at least 1 anticholinergic and/or sedative medication, as measured by the DBI Calculator on discharge compared to admission
Timepoint [1] 330266 0
At discharge from hospital admission
Secondary outcome [1] 405518 0
Any reduction of total DBI on discharge compared to admission using data extracted from the hospital electronic medical records (prescribing outcome)
Timepoint [1] 405518 0
At discharge from hospital admission
Secondary outcome [2] 405519 0
Changes in DBI between admission and discharge using data extracted from the hospital electronic medical records (prescribing outcome)
Timepoint [2] 405519 0
At discharge from hospital admission
Secondary outcome [3] 405520 0
Any increase of total DBI on discharge compared to admission using data extracted from the hospital electronic medical records (prescribing outcome)
Timepoint [3] 405520 0
At discharge from hospital admission
Secondary outcome [4] 405521 0
Any documentation of recommending deprescribing at least one DBI medication in the discharge summary using data extracted from the hospital electronic medical records (prescribing outcome)
Timepoint [4] 405521 0
At discharge from hospital admission
Secondary outcome [5] 405522 0
Any in-hospital deprescribing of any drug using data extracted from the hospital electronic medical records (prescribing outcome)
Timepoint [5] 405522 0
At discharge from hospital admission
Secondary outcome [6] 405523 0
Any documentation of recommending deprescribing any drug in the discharge summary using data extracted from the hospital electronic medical records (prescribing outcome)
Timepoint [6] 405523 0
At discharge from hospital admission
Secondary outcome [7] 405524 0
Prevalence of in-hospital falls using data extracted from the hospital electronic medical records (clinical outcome)
Timepoint [7] 405524 0
At discharge from hospital admission
Secondary outcome [8] 405525 0
Prevalence of in-hospital pressure sores using data extracted from the hospital electronic medical records (clinical outcome)
Timepoint [8] 405525 0
At discharge from hospital admission
Secondary outcome [9] 405526 0
Prevalence of in-hospital delirium using data extracted from the hospital electronic medical records (clinical outcome)
Timepoint [9] 405526 0
At discharge from hospital admission
Secondary outcome [10] 405527 0
All cause readmission using data-linkage to the hospital electronic medical records via the Centre for Health Record Linkage (clinical outcome)
Timepoint [10] 405527 0
28 days and 1 year after discharge from baseline hospital admission, or time-to-event outcome
Secondary outcome [11] 405528 0
Falls related readmission using data-linkage to the hospital electronic medical records via the Centre for Health Record Linkage (clinical outcome)
Timepoint [11] 405528 0
28 days and 1 year after discharge from first hospital admission involving a fall, or time-to-event outcome
Secondary outcome [12] 405529 0
Pressure sore related readmission using data-linkage to the hospital electronic medical records via the Centre for Health Record Linkage (clinical outcome)
Timepoint [12] 405529 0
28 days and 1 year after discharge from first hospital admission involving a pressure sore, or time-to-event outcome
Secondary outcome [13] 405530 0
Delirium related readmission using data-linkage to the hospital electronic medical records via the Centre for Health Record Linkage (clinical outcome)
Timepoint [13] 405530 0
28 days and 1 year after discharge from first hospital admission involving delirium, or time-to-event outcome
Secondary outcome [14] 405531 0
Adverse drug reaction related readmission using data-linkage to the hospital electronic medical records via the Centre for Health Record Linkage (clinical outcome)
Timepoint [14] 405531 0
28 days and 1 year after discharge from first hospital admission involving an adverse drug reaction, or time-to-event outcome
Secondary outcome [15] 405532 0
Mortality using data-linkage to the hospital electronic medical records via the Centre for Health Record Linkage (clinical outcome)
Timepoint [15] 405532 0
28 days and 1 year after discharge from baseline hospital admission, or time-to-event outcome
Secondary outcome [16] 405533 0
New admissions to residential aged care facilities using data-linkage to the hospital electronic medical records via the Centre for Health Record Linkage (clinical outcome)
Timepoint [16] 405533 0
28-day and 1 year after discharge from baseline hospital admission, or time-to-event outcome
Secondary outcome [17] 405534 0
Patient reported experience measures on medication review in hospital assessed using NSW TAG Patient Reported Experience Measures (patient reported outcome)
Timepoint [17] 405534 0
At discharge from hospital admission
Secondary outcome [18] 405535 0
Goals of Care assessed using Goal-directed Medication review Electronic Decision Support System (G-MEDSS)© (patient reported outcome)
Timepoint [18] 405535 0
At discharge from hospital admission
Secondary outcome [19] 405536 0
Quality of Life assessed using EQ-5D-3L (patient reported outcome)
Timepoint [19] 405536 0
At discharge and 3 months after discharge from hospital admission
Secondary outcome [20] 405537 0
Patient attitudes to deprescribing assessed using screening global question from revised Patient Attitudes to Deprescribing Questionnaire: Versions for Older Adults and Caregivers (patient reported outcome)
Timepoint [20] 405537 0
At discharge from hospital admission
Secondary outcome [21] 405540 0
Barriers and enablers generated from the mixed methods analysis of self-administered questionnaires (that were specifically designed for the study) and interviews/focus groups of patients and carers
Timepoint [21] 405540 0
At discharge from hospital admission
Secondary outcome [22] 407029 0
Barriers and enablers generated from the mixed methods analysis of self-administered questionnaires (that were specifically designed for the study) and interviews/focus groups of hospital clinicians
Timepoint [22] 407029 0
At discharge from hospital admission
Secondary outcome [23] 407030 0
Barriers and enablers generated from the mixed methods analysis of self-administered questionnaires (that were specifically designed for the study) and interviews/focus groups of general practitioners
Timepoint [23] 407030 0
At discharge from hospital admission
Secondary outcome [24] 407031 0
Composite list of barriers and enablers generated from the mixed methods analysis of self-administered questionnaires (that were specifically designed for the study) and interviews/focus groups of patients/carers, hospital clinicians and general practitioners
Timepoint [24] 407031 0
At discharge from hospital admission

Eligibility
Key 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
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealment of the hospital 'steps' was conducted using a random number generator by a researcher who is external to the research team.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation based on the 'randbetween' function in Microsoft Excel.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
This randomised control trial employs a stepped wedge study design. Each hospital will be considered a ‘step’ when implementing the DBI Stewardship Program for the stepped wedge trial period.

The pre-trial data period will capture the changes resulting from implementation of the bundle into the EMR and will be used to evaluate the impact of the bundle without the presence of the DBI Stewardship Program. The pre-trial period for each hospital is split into two phases. In Phase 1, the DBI Calculator will be switched on without clinician awareness (ie running in the background) to collect baseline DBI data for 12 weeks. In Phase 2, the DBI Calculator and all components of the bundle will be made available to the clinicians.

After the 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. There will be some socialisation of the project and training in the last week of the control period and first week of the intervention period for each hospital site.
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Descriptive statistics will be used to report the demographics of the study populations at baseline. Binary outcomes will be analysed using multilevel logistic regression, with hospital modelled as a random effect and adjusting for study period, patients’ covariates. Continuous outcomes will be analysed using multilevel linear regression, again adjusting for study period, patients’ covariables and cluster (hospital). Count outcomes will be analysed using multilevel Poisson regression or negative binomial regression depending on the distribution. Time-to-event outcomes will be analysed using multilevel Cox proportional hazards regression. We will also perform pre-planned subgroup analyses by age, gender, comorbidity, culturally and linguistically diverse (CALD) background, DBI on admission, drug class, number of medications, frailty, hospital and specialty service.

The impact of the Intensive Stewardship Program on outcomes could decrease during the less-intensive DBI Stewardship and bundle period (sustainability phase). Therefore, we will evaluate whether the effect size of intensive DBI Stewardship Program with the bundle will be maintained over time throughout the study by including an interaction term. Primary and secondary outcomes will be conducted according to intention-to-treat (ITT) principles. We will also perform a per-protocol (PP) analysis by excluding patient data admitted during any periods when DBI MPage did not turn on as expected or when the DBI Steward was away for 50% of the planned sessions.

In some analyses, older adults whose hospital stay crossed over the transition periods of the study will be excluded. For example, individuals who were admitted during the control period then discharged during the intervention period will be excluded when evaluating the prescribing and clinical outcomes in the control period compared to the intervention period. Inclusion of these individuals' data for this analysis may create artefacts in the results through (incorrectly) attributing effect (or lack of effect) to the intervention.

Barriers and enablers of the tool bundle: Qualitative data from survey open responses and interviews/focus groups will be analysed using conventional content analysis or the Consolidated Framework for Implementation Research (CFIR) to create themes, identifying barriers to and enablers of medication review in older adults with frailty in hospital. Using a triangulation design model, the quantitative (intervention results plus survey closed responses) and qualitative data will be collected simultaneously and analysed separately, after which the two sets of results will be compared, looking for consistency or contrast among the results.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
11/04/2022
Actual
19/04/2022
Date of last participant enrolment
Anticipated
11/04/2023
Actual
Date of last data collection
Anticipated
11/04/2024
Actual
Sample size
Target
1290
Accrual to date
5
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 21565 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [2] 21566 0
Ryde Hospital - Eastwood
Recruitment hospital [3] 21567 0
Hornsby Ku-ring-gai Hospital - Hornsby
Recruitment hospital [4] 21568 0
Wyong Public Hospital - Hamlyn Terrace
Recruitment hospital [5] 21569 0
Gosford Hospital - Gosford
Recruitment hospital [6] 21570 0
Woy Woy Public Hospital - Woy Woy
Recruitment postcode(s) [1] 36480 0
2065 - St Leonards
Recruitment postcode(s) [2] 36481 0
2122 - Eastwood
Recruitment postcode(s) [3] 36482 0
2077 - Hornsby
Recruitment postcode(s) [4] 36483 0
2259 - Hamlyn Terrace
Recruitment postcode(s) [5] 36484 0
2250 - Gosford
Recruitment postcode(s) [6] 36485 0
2256 - Woy Woy

Funding & Sponsors
Funding source category [1] 310633 0
Government body
Name [1] 310633 0
National Health and Medical Research Council
Country [1] 310633 0
Australia
Primary sponsor type
Government body
Name
Northern Sydney Local Health District
Address
Level 14 Kolling Building
Royal North Shore Hospital,
Reserve Road,
St Leonards, NSW, 2065
Country
Australia
Secondary sponsor category [1] 311847 0
None
Name [1] 311847 0
Address [1] 311847 0
Country [1] 311847 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310235 0
Northern Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 310235 0
Ethics committee country [1] 310235 0
Australia
Date submitted for ethics approval [1] 310235 0
27/10/2021
Approval date [1] 310235 0
01/12/2021
Ethics approval number [1] 310235 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 116950 0
Prof Sarah Hilmer
Address 116950 0
Department of Clinical Pharmacology
Level 13 Kolling Building,
Royal North Shore Hospital,
Reserve Road,
St Leonards, NSW, 2065
Country 116950 0
Australia
Phone 116950 0
+61 2 9926 4481
Fax 116950 0
+61 2 9926 4053
Email 116950 0
sarah.hilmer@sydney.edu.au
Contact person for public queries
Name 116951 0
Sarah Hilmer
Address 116951 0
Department of Clinical Pharmacology
Level 13 Kolling Building,
Royal North Shore Hospital,
Reserve Road,
St Leonards, NSW, 2065
Country 116951 0
Australia
Phone 116951 0
+61 2 9926 4481
Fax 116951 0
+61 2 9926 4053
Email 116951 0
sarah.hilmer@sydney.edu.au
Contact person for scientific queries
Name 116952 0
Sarah Hilmer
Address 116952 0
Department of Clinical Pharmacology
Level 13 Kolling Building,
Royal North Shore Hospital,
Reserve Road,
St Leonards, NSW, 2065
Country 116952 0
Australia
Phone 116952 0
+61 2 9926 4481
Fax 116952 0
+61 2 9926 4053
Email 116952 0
sarah.hilmer@sydney.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
A waiver of consent was obtained to collect, access, use and disclose patient data for this research project only. Therefore, neither individual patient data nor the study data are accessible to other researchers or third-parties.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.