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Trial registered on ANZCTR


Registration number
ACTRN12617000765325
Ethics application status
Approved
Date submitted
1/05/2017
Date registered
24/05/2017
Date last updated
24/05/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Minimising the Functional Burden of Medications in Older Inpatients:
Implementation of the Drug Burden Index
Scientific title
Minimising the Functional Burden of Medications in Older Inpatients:
Implementation of the Drug Burden Index
Secondary ID [1] 291719 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
adverse effects 302899 0
frailty 302900 0
falls 302901 0
high risk medications 302902 0
Condition category
Condition code
Musculoskeletal 302388 302388 0 0
Normal musculoskeletal and cartilage development and function
Mental Health 302390 302390 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 297804 0
Prevention
Intervention code [2] 297943 0
Treatment: Other
Comparator / control treatment
Control group- Calculate DBI using software for the purpose of monitoring DBI to compare with intervention group, but do not provide report to team. There will be no interaction between the pharmacist and the patient's treating team if randomised to the control group.
Control group
Active

Outcomes
Primary outcome [1] 301798 0
Changes in prescribing outcomes: proportion of patients in whom DBI is decreased, unchanged and increased at discharge will be calculated and compared between intervention and control groups using chi-square tests.

This will be assessed by comparing the DBI score calculated on admission and discharge (using the online DBI calculator tool). The pharmacist will obtain a best possible medication history on admission which will be used to calculate the DBI score on admission. On discharge, the list of medications in the patient's hospital discharge referral will be used to calculate DBI score on discharge.

Timepoint [1] 301798 0
At hospital admission and discharge
Primary outcome [2] 302152 0
Changes in prescribing outcomes at follow-up: proportion of patients in whom DBI is decreased, unchanged and increased at 3 and 6 months after discharge compared to DBI on admission to hospital will be calculated and compared between intervention and control groups using chi-square tests.

This will be assessed by comparing the DBI score calculated on admission and at 3 and 6 months after dischange (using the online DBI calculator tool). The pharmacist will obtain a best possible medication history on admission which will be used to calculate the DBI score on admission.

During the 3 and 6 month (post discharge) follow up phone calls, the patient will be asked what medications they are currently taking and where appropriate, confirmed with a second source (e.g. GP, pharmacist, nursing home records). This list of medications will be used to calculate their DBI score (using the online DBI calculator tool) at follow up. This will be compared with their DBI calculated on admission to hospital.
Timepoint [2] 302152 0
3 months and 6 months post discharge
Secondary outcome [1] 333885 0
Mean frailty scores will be compared between intervention and control groups at baseline, 3 and 6 months.

Mean frailty scores will be calculated after administration of the Reported Edmonton Frail Scale (REFS) (out of a total of 18 points) at baseline. This same questionnaire will be repeated over the phone as part of the 3 and 6 month (post discharge) follow up phone calls (which will be out of 16 points since the clock drawing exercise cannot be completed over the phone).
Timepoint [1] 333885 0
At baseline and at follow up at 3 months and 6 months (post discharge from the hospital admission during which they were recruited)
Secondary outcome [2] 334975 0
Prevalence of adverse drug reactions (clinical outcome). This will be compared between intervention and control groups using chi-square tests.

Prevalence of adverse drug reactions will be extracted from review of routinely collected data in the medical records on discharge. Adverse drug events will also be assessed by a second, blinded, independent reviewer of the medical records and classified using Naranjo criteria. During the 3 and 6 month (post discharge) follow up phone calls, the patient will be asked if they have had experienced an adverse drug reaction since hospital discharge.
Timepoint [2] 334975 0
Discharge, and 3 and 6 month (post discharge) follow up phone calls
Secondary outcome [3] 334977 0
Prevalence and number of falls. On hospital admission, the patient will be asked if they have experienced a fall in the preceding 6 months, Any falls during hospital (inpatient falls) will be extracted from review of the patient's medical records. During the 3 and 6 month (post discharge) follow up phone calls, the patient will be asked if they have had a fall since discharge. This will be compared between intervention and control groups using chi-square tests (prevalence) and independent t tests.
Timepoint [3] 334977 0
Baseline, hospital discharge and 3 and 6 months after discharge from hospital admission during which they were recruited.
Secondary outcome [4] 334979 0
Feasibility: descriptive statistics of staff time required and cost analysis

The pharmacist will record the time taken to enter the medications in the DBI online calculator, time taken to generate the DBI report (using a stopwatch) as well as estimate the time taken to discuss the report with the registrar/consultant.

A cost analysis will be undertaken which will consider the time and cost involved (e.g. hourly rate of pharmacist) to calculate the patient's DBI score and time taken to generate the report,

Descriptive statistics including mean, median and range will be used to analyse this outcome.
Timepoint [4] 334979 0
Duration of admission during which patient is recruited.
Secondary outcome [5] 334980 0
Patient evaluation of the intervention.

At discharge, patients will be asked two questions to rank their satisfaction with their medication management in hospital on a likert scale from 1 to 10. These questions were designed specifically for this study. The first question is “How satisfied are you with your medication management in hospital overall?” and if their medication(s) have been changed, “How satisfied are you with your medication changes in hospital overall?”

Descriptive statistics will be used to summarise this.
Timepoint [5] 334980 0
Hospital discharge
Secondary outcome [6] 334981 0
Hospital staff evaluation of the intervention.

Hospital staff will be emailed 5 questions about their satisfaction with the DBI reports provided by the pharmacist. These questions were designed specifically for this study. Questions were tailored to gauge hospital doctros thoughts of the format of the DBI report, the information provided on the DBI report and incorporation of DBI report into electronic medication management hospital systems.

Descriptive statistics will be used to summarise this.
Timepoint [6] 334981 0
Within 12 weeks of intervention
Secondary outcome [7] 335055 0
GP evaluation of the intervention.

At discharge, General Practitioners (GPs) will be asked 3 questions on their thoughts of the DBI report (that will be faxed to them on discharge). The questions were slightly modified from a previously developed questionnaire, which was used as part of a feasibility study of a previous version of the DBI calculator for accredited pharmacists in the community.

Descriptive statistics will be used to summarise this.
Timepoint [7] 335055 0
At hospital discharge
Secondary outcome [8] 335058 0
Institutionalisation on follow up (3 and 6 months) will be compared between intervention and control groups using chi-square tests.

During the 3 and 6 month (post discharge) follow up phone calls, the patient/GP/Facility manager will be asked if, since discharge, the patient has moved to a residential aged care facility.
Timepoint [8] 335058 0
3 and 6 months after discharge from hospital admission during which they were recruited
Secondary outcome [9] 335059 0
Prevalence of pressure areas. This will be compared between intervention and control groups using chi-square tests.

Prevalence of pressure areas during admission will be extracted from review of the medical records. If a patient has a pressure area this will routinely be documented in the medical records. This will be collected in the following categories: pressure area on admission (Yes/no), new pressure area, pressure area worsened during admission, pressure area same during admission.
Timepoint [9] 335059 0
At hospital discharge
Secondary outcome [10] 335061 0
Length of stay will be collected from medical records and compared between the intervention and control group using independent t test.
Timepoint [10] 335061 0
Hospital discharge
Secondary outcome [11] 335062 0
Mortality at 3 and 6 months post-discharge will be compared between intervention and control groups using chi-square tests. Mortality may be confirmed with medical records, GP, and/or Births, Deaths and Marriages when necessary.
Timepoint [11] 335062 0
3 and 6 months post discharge from the hospital admission during which they were recruited

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

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (Microsoft excel)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
The primary outcome will be analysed by a statistician who is blinded
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
The study is powered to detect a clinically significant change in the Drug Burden Index. A reduction of 0.5 points is associated with clinically significant differences in physical function and falls.
Based on previous studies in medical inpatients we estimate 30-40% of patients will have DBI >0.5 on admission and that DBI is not reduced in the usual care group. We estimate that the DBI report will result in 25-50% of eligible patients reducing DBI by 0.5. Therefore, we need 100-180 in each study group to be powered at 80% to detect a clinically relevant reduction in DBI in the intervention group. Allowing for loss to follow-up, we aim to recruit 200 to each study group.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
12/04/2016
Date of last participant enrolment
Anticipated
Actual
11/11/2016
Date of last data collection
Anticipated
9/06/2017
Actual
Sample size
Target
400
Accrual to date
Final
253
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 7860 0
Royal North Shore Hospital - St Leonards
Recruitment postcode(s) [1] 15803 0
2065 - St Leonards

Funding & Sponsors
Funding source category [1] 296219 0
Government body
Name [1] 296219 0
Agency for Clinical Innovation
Country [1] 296219 0
Australia
Primary sponsor type
Hospital
Name
Royal North Shore Hospital
Address
Reserve Rd, St Leonards NSW 2065
Country
Australia
Secondary sponsor category [1] 295130 0
University
Name [1] 295130 0
University of Sydney
Address [1] 295130 0
Camperdown NSW 2006
Country [1] 295130 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297458 0
Northern Sydney Local Health District
Ethics committee address [1] 297458 0
Ethics committee country [1] 297458 0
Australia
Date submitted for ethics approval [1] 297458 0
14/12/2015
Approval date [1] 297458 0
15/01/2016
Ethics approval number [1] 297458 0
HREC/15/HAWKE/477

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

Contacts
Principal investigator
Name 74098 0
Prof Sarah Hilmer
Address 74098 0
Level 12, Kolling Building, Royal North Shore Hospital
Reserve Rd, St Leonards, NSW 2065
Country 74098 0
Australia
Phone 74098 0
+ 61 2 9926 4481
Fax 74098 0
+61 2 9926 4053
Email 74098 0
sarah.hilmer@sydney.edu.au
Contact person for public queries
Name 74099 0
Sarah Hilmer
Address 74099 0
Level 12, Kolling Building, Royal North Shore Hospital
Reserve Rd, St Leonards, NSW 2065
Country 74099 0
Australia
Phone 74099 0
+ 61 2 9926 4481
Fax 74099 0
+61 2 9926 4053
Email 74099 0
sarah.hilmer@sydney.edu.au
Contact person for scientific queries
Name 74100 0
Sarah Hilmer
Address 74100 0
Level 12, Kolling Building, Royal North Shore Hospital
Reserve Rd, St Leonards, NSW 2065
Country 74100 0
Australia
Phone 74100 0
+ 61 2 9926 4481
Fax 74100 0
+61 2 9926 4053
Email 74100 0
sarah.hilmer@sydney.edu.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseCalculating and using the drug burden index score in research and practice.2018https://dx.doi.org/10.1080/17512433.2018.1528145
N.B. These documents automatically identified may not have been verified by the study sponsor.