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Trial registered on ANZCTR


Registration number
ACTRN12617001301358
Ethics application status
Approved
Date submitted
29/08/2017
Date registered
11/09/2017
Date last updated
11/09/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
The effects of calculating and communicating to General Practitioners a Drug Burden Index (DBI) in elderly patients discharged from the Emergency Department- a pilot study
Scientific title
The effects of calculating and communicating to General Practitioners a Drug Burden Index (DBI) in elderly patients discharged from the Emergency Department and determining the extent of inappropriate polypharmacy in that population - a pilot study
Secondary ID [1] 292745 0
None
Universal Trial Number (UTN)
U1111-1201-3032
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Inappropriate polypharmacy 304520 0
Condition category
Condition code
Public Health 303857 303857 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Name of intervention: Drug Burden Index (DBI) tool

The initial stage of this study (the pre-intervention phase) will assess the extent of multiple medication use within the RNSH ED patient cohort. This will be accomplished by conducting an audit of medication use amongst the study cohort. A sequential sample of 250 patients who are over the age of 65 years, without significant cognitive impairment (ie Six Item Screener score of >4), who have presented to the ED and have been discharged to home, will be selected. Patient records relating to that ED presentation will be scrutinised and information regarding medications taken will be extracted for analysis. The data to be collected is detailed in the ‘Data collection’ section below.

Intervention phase: subject to confirmation from the audit that polypharmacy is indeed a concern, the study will then evaluate the benefits, if any, of communicating elderly patients’ Drug Burden Index scores to their GPs. We will use convenience sequential sampling to recruit our study population. The study will run for 12 months. Recruiting will be continuous throughout the first six months of the study or until the target sample size of 250 participants is achieved, whichever occurs first. The pre-audit will be conducted by a Research Pharmacist (RP). Potential participants will be approached by the RP after the decision has been made to discharge them to home. The RP will introduce him/herself and ask the patient if they are interested in hearing about a research project which they could potentially participate in. The RP will give a short verbal explanation of the project, and if the person indicates that they are interested, will provide the potential participant with an information sheet and consent form. The RP will go through these documents with the person if required and will answer any questions about the project. If the person decides to participate they will be requested to sign the Consent form. It will be made clear to all potential participants that their participation is entirely voluntary, can be withdrawn with no consequences at any time, and that their care will be completely unaffected by their decisions in this matter.

We will calculate a DBI for all elderly patients who present to the ED prior to their discharge home. All patients discharged from Australian EDs are required to be given a Discharge Referral Note (DRN) documenting their ED assessment and treatment. The DRN is also transmitted electronically to the patient’s nominated GP and it is feasible to e-attach the ED-calculated DBI to the patient DRN.

In addition, we will follow-up consenting patients by telephone one month and six months after their discharge from ED to ascertain whether their GPs have acted upon the DBI information in their patients’ DRN. We will then attempt to re-calculate repeat DBIs to compare against the ED-calculated value, and thus gain insights into how effective and sustainable the DBI/DRN approach is in influencing GP prescribing behaviour.

Data collection:

Pre-intervention phase:

The following data will be collected: Medical Record Number (MRN), Age, Gender, Presenting problem(s), any relationship of presenting problems to medications taken, the number of presentations during a) the previous month and b) the previous year; and the generic names and 24-hour dosage of medications with: Anticholinergic, Sedative, or Vasodilating properties, beta or calcium channel blockers, and analgesics. These data will be collated by a Doctor or Research Pharmacist from First Net. The pre-intervention phase will be conducted subject to a waiver of consent

Intervention phase:

Data collection point 1: collate information collected as part of routine ED procedures regarding participants’ prescribed medications, record reason for ED presentation

Data collection point 2: collect information on participants’ prescribed medications during first (1 month post-discharge) telephone interview

Data collection point 3: collect information on participants’ prescribed medications during second (6 month post-discharge) telephone interview, and information regarding having been re-admitted to an ED.


The burden of each individual medication (B) is calculated by the following equation:

B = D/(d + D)

where: D is the daily dose taken by the subject, and d is the minimum efficacious daily dose. . For each medication, the drug burden can range from 0 to 1. A value of 0.5 indicates the dose to be the minimum recommended daily dose.

The Burden, B, may be due to effects associated with anticholinergic drugs (BAC) or sedative drugs (Bs), respectively. The Drug Burden Index is defined as the sum of the burdens of the anticholinergic and sedative properties of medications (Hilmer 2009). Assuming that the anticholinergic and sedative effects of different drugs are additive in a linear fashion, it is postulated that BAC and BS are proportional to a linear additive model of pharmacological effect. Therefore,

Total Drug Burden (DBI) = BAC + BS

where: BAC and BS each represent the linear additive sum of D/(d + D) for every anticholinergic or sedative drug to which the subject is exposed.

And: D is the daily dose taken by the subject:

and d is the minimum efficacious daily dose.

DBI results can be categorised as low-, medium-, or high-range. The latter two categories are associated with the most adverse effects and indicate that the patient’s prescribed medications should be reviewed with the aim of removing unnecessary medications and making other adjustments as appropriate. For this study, a low (individual) drug burden is defined as <0.5, a ‘medium’ is defined as between 0.51 and 1.0 and high drug burden is defined as more than or equal to 1.01.

This study will run for 12 months. The pre-intervention phase will commence in July 2017 and will be completed within that month.

Recruiting for the intervention phase will commence in August 2017 and will be ongoing until 250 participants are recruited, or until the end of January 2018, whichever occurs first. Follow-ups will occur from the beginning of September 2017 until the completion of the project in July 2018.
Intervention code [1] 298986 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 303213 0
Primary outcome: To demonstrate that inappropriate polypharmacy in this group can be reduced by effectively communicating to GPs the burden of toxic and/or unnecessary medications being taken by their patients.

This achieved by:

All consenting patients will have their DBI scores calculated at three points in time: admission to ED, one month after their discharge, and six months after their discharge. Post-discharge data collection will be via telephone follow-up interview. The DBI will then be calculated at these 3 points and will be compared to see if there is a reduction in DBI.

The calculation of the DBI is described in Step 3 (Intervention/exposure)
Timepoint [1] 303213 0
Timepoint: 1 month and 6 months post discharge
Primary outcome [2] 303304 0
Primary outcome: To quantify the extent of inappropriate polypharmacy among older patients who present to the ED and are later discharged to home.

The initial stage of this study (the pre-intervention phase) will assess the extent of multiple medication use within the RNSH ED patient cohort. This will be accomplished by conducting an audit of medication use amongst the study cohort. A sequential sample of 250 patients who are over the age of 65 years, without significant cognitive impairment (ie Six Item Screener score of >4), who have presented to the ED and have been discharged to home, will be selected. Patient records relating to that ED presentation will be scrutinised and information regarding medications taken will be extracted for analysis.

The calculation of the DBI is described in Step 3 (Intervention/exposure)
Timepoint [2] 303304 0
Pre intervention phase, 1 month before intervention phase
Secondary outcome [1] 338258 0
To calculate the incidence of medium and High Drug Burden Index scores among the RNSH ED patient cohort. (This is a composite outcome).

This is achieved by:

Calculating:

· Proportion of patients taking 0, 1, 2, 3, 4, or [5 or more] medications

· Among the population taking one or more medication, calculate the proportion of patients taking medications from each of the medication groups: (anticholinergic, sedative, vasodilators, beta or calcium channel blockers, analgesics)

· Assess the proportion of patients taking 5 or more medications

· Calculate DBIs for all patients in this sample (Calculation of DBI is described in Step 3 : Intervention/Exposure)

- For this study, a low (individual) drug burden is defined as <0.5, a ‘medium’ is defined as between 0.51 and 1.0 and high drug burden is defined as more than or equal to 1.01. The incidence of medium and high DBI will be determined from this definition.

Timepoint [1] 338258 0
Pre intervention phase, 1 month before intervention phase
Secondary outcome [2] 338372 0
To determine what changes, if any, are seen in patients’ DBI scores one month after their discharge from ED.

Assess changes in participants’ Drug Burden Index after GPs receive their patients’ DBIs after discharge from ED. This is achieved by calculating the patients' DBI after one month. Information in regards to changes in their prescribed medication are obtained via phone interview. The DBI at ED presentation and DBI 1 months post discharge will be compared.
Timepoint [2] 338372 0
One month after patients are discharged from ED
Secondary outcome [3] 338373 0
To determine if any of these changes in patients’ DBI sustainable over a six month period.

This is achieved by calculating the patients' DBI after six months post discharge. Information in regards to changes in their prescribed medication are obtained via phone interview. The DBI at 1 month post discharge and DBI 6 months post discharge will be compared
Timepoint [3] 338373 0
6 months post discharge from ED
Secondary outcome [4] 338374 0
To determine if there is any evidence that re-presentation rates are related to changes in DBI.

This is achieved by calculating the patients DBI after six months post discharge. Information in regards to re-presentation to the ED will be obtained via phone interview
Timepoint [4] 338374 0
6 months post discharge
Secondary outcome [5] 338375 0
To determine what changes, if any, are made to patients’ prescribed medications by their GPs after the receipt by the GP of Drug Burden Index scores for their patients.

Information in regards to changes in their prescribed medication are obtained via phone interview
Timepoint [5] 338375 0
1 month post discharge
Secondary outcome [6] 338565 0
To determine any gross association between patients with medium and high DBIs and the number of presentations to ED the month before or the year before (This is a composite outcome).

This is achieved by:

- For this study, a low (individual) drug burden is defined as <0.5, a ‘medium’ is defined as between 0.51 and 1.0 and high drug burden is defined as more than or equal to 1.01. The incidence of medium and high DBI will be determined from this definition.

- The medical records of these patients will then be looked at to determine if they had previous ED presentations in the past month or the past year.

Timepoint [6] 338565 0
Pre intervention phase, 1 month before intervention phase

Eligibility
Key inclusion criteria
Patients > 65 years of age without significant cognitive impairment (ie Six Item Screener score of >4) who are taking at least one prescribed medication and who have attended Royal North Shore Hospital Emergency Department and were discharged to home.
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients below the age of 65 years, patients who do not take any prescribed medications, patients with significant cognitive impairments, or patients who are admitted to RNSH as in-patients or who are transferred as in -patients to another care facility (eg rehab, private hospital).

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The sample size is limited by the period of available funding for the project (12 months) and the expected number of potential participants presenting to ED during this six month period. In the absence of any pilot data, if we look at a 50% change in DBI over the period of the study with alpha 0.05/beta 0.2 and 80% power, our target sample is 126 patients over the period of the trial. However 500 would be the preferred target to add robustness to clinical significance.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
18/09/2017
Actual
Date of last participant enrolment
Anticipated
31/01/2018
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
500
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 8900 0
Royal North Shore Hospital - St Leonards
Recruitment postcode(s) [1] 17146 0
2065 - St Leonards

Funding & Sponsors
Funding source category [1] 297383 0
Charities/Societies/Foundations
Name [1] 297383 0
HCF Research Foundation
Country [1] 297383 0
Australia
Primary sponsor type
Individual
Name
Dr Mark Gillett
Address
Emergency Department, Royal North Shore Hospital, Reserve Rd., St. Leonards, NSW 2065
Country
Australia
Secondary sponsor category [1] 296367 0
Individual
Name [1] 296367 0
Dr Sarah Wilks
Address [1] 296367 0
Emergency Department, RNSH, Reserve Rd., St. Leonards, NSW 2065
Country [1] 296367 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298484 0
Northern Sydney Local Health District
Ethics committee address [1] 298484 0
Ethics committee country [1] 298484 0
Australia
Date submitted for ethics approval [1] 298484 0
13/02/2017
Approval date [1] 298484 0
14/08/2017
Ethics approval number [1] 298484 0
RESP/17/14

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 1999 1999 0 0
/AnzctrAttachments/373543-Drug Burden Index Protocol Version 2 10.03.2017 amendments highlighted.docx (Protocol)
Attachments [2] 2000 2000 0 0
/AnzctrAttachments/373543-Patient Information and Consent Form- Royal North Shore Hospital Drug Burden Index study- Version 2 08.03.2017 amendments highlighted.doc (Participant information/consent)
Attachments [3] 2001 2001 0 0
/AnzctrAttachments/373543-Letter - HREC FINAL approval - HREC meeting 14 August 2017 - RESP1714.pdf (Ethics approval)

Contacts
Principal investigator
Name 77230 0
Dr Mark Gillett
Address 77230 0
Emergency Department, Royal North Shore Hospital, Reserve Rd., St. Leonards, NSW 2065
Country 77230 0
Australia
Phone 77230 0
+612 9463 2228 / +61457 829 396
Fax 77230 0
Email 77230 0
mgillett@med.usyd.edu.au
Contact person for public queries
Name 77231 0
Mark Gillett
Address 77231 0
Emergency Department, Royal North Shore Hospital, Reserve Rd., St. Leonards, NSW 2065
Country 77231 0
Australia
Phone 77231 0
+612 9463 2228 / +61457 829 396
Fax 77231 0
Email 77231 0
mgillett@med.usyd.edu.au
Contact person for scientific queries
Name 77232 0
Mark Gillett
Address 77232 0
Emergency Department, Royal North Shore Hospital, Reserve Rd., St. Leonards, NSW 2065
Country 77232 0
Australia
Phone 77232 0
+612 9463 2228 / +61457 829 396
Fax 77232 0
Email 77232 0
mgillett@med.usyd.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

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