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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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12617001301358
Enrollment
500
Registered
2017-09-11
Start date
2017-09-18
Completion date
2018-01-31
Last updated
2017-10-02

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

Conditions

None listed

Brief summary

Title: Benefits of calculating and communicating to GPs a Drug Burden Index (DBI) in elderly patients discharged from the Emergency Department- a pilot study The purpose of the study is to investigate whether Emergency Department visits by older people who are taking one or more prescribed medications can be reduced by effectively communicating to primary care providers the burden of toxic and/or unnecessary medications being taken by their patients. We are investigating to see if some patients’ prescribed medications may no longer be necessary. We are also investigating whether some people’s combinations of prescribed medications might have side-effects that could make them more liable to experience adverse effects such as falls, dizziness and confusion. We aim to accomplish this by calculating a Drug Burden Index. The Drug Burden Index (DBI) calculation takes account of the total amounts of all the different types (‘classes’) of prescribed medicines a person is using. Two classes of prescribed medications (anticholinergics and sedatives) in particular are associated with adverse clinical outcomes. The calculated Drug Burden Index measures a person’s cumulative exposure to these medications and its potential impact on physical and cognitive function. The calculated Drug Burden Index and accompanying explanatory material will be appended to the discharge letter sent to all patients’ GPs after their Emergency Department visit. We encourage patients to discuss this matter with their GPs at the next opportunity. If the calculated Drug Burden Index indicates that a person might potentially be adversely affected by their prescribed medications, this is an opportunity for the GP to review and adjust medications where indicated. By collecting this and other information we hope to gain a better understanding of how many visits to Emergency Departments may be related to unnecessary or interacting prescribed medications, with the aim of ultimately reducing these preventable visits by encouraging GPs to review and adjust prescriptions. The study is to be conducted wholly at the Emergency Department of Royal North Shore Hospital and the expected duration of the study is 1 year.

Interventions

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

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.

Sponsors

Dr Mark Gillett
Lead SponsorIndividual

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment

Eligibility

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

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.

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).

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026