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Trial registered on ANZCTR


Registration number
ACTRN12609000599279
Ethics application status
Approved
Date submitted
15/07/2009
Date registered
20/07/2009
Date last updated
9/12/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
A prospective observational study - understanding the burden of adverse drug reactions and their impact on symptoms at end of life
Scientific title
A prospective observational study - understanding the burden of adverse drug reactions and their impact on symptoms at end of life in palliative care patients.
Secondary ID [1] 283724 0
Prospective phase 4 study, 009
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Palliative care admissions 237259 0
Condition category
Condition code
Other 239578 239578 0 0
Conditions of unknown or disputed aetiology (such as chronic fatigue syndrome/myalgic encephalomyelitis)

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
All people admitted to participating palliative care units will be asked to provide access to their case notes for collection of admission data. This data will include information about their symptoms on admission, any medications they are taking at the time of admission, and any investigations undetaken, this will all be collected from the admission case notes. An assessment of possible adverse drug reactions will be made based on this data. All people admitted to participating palliative care services over the 3 month study period will be asked to participate. A single set of data will be collected.

In addition, a subset of patients will be asked to participate in an interview to ask further questions about their symptoms, the impact of these symtpoms, medications being taken, any problems or side effects experienced, and their beliefs about medicines. These participants will be asked to allow a single interview, weekly completion of a simple prompt diary each week, and telephone calls each week until end February 2010.
Intervention code [1] 236944 0
Not applicable
Comparator / control treatment
Not applicable
Control group
Uncontrolled

Outcomes
Primary outcome [1] 238375 0
To evaluate the prevalence, clinical characteristics and avoidability of advere drug reactions (ADR)-related referrals to palliative care services and ADRs that occur in a cohort of palliative patients longitudinally.
The Naranjo scale will be used to assess probability of an ADR.
Causality and classification will be assessed using the Scale by Edwards and Aronson (Lancet 2000).
Severity of the ADR will be assessed using the World Health Organisation Adverse Reaction Terminology (WHO-ART).
Timepoint [1] 238375 0
Admission to palliative care
Secondary outcome [1] 244820 0
To compare patient reported adverse drug reaction and those recorded in the clinical record through patient interview
Timepoint [1] 244820 0
Admission and weekly follow-up for up to 12 weeks or until end February 2010
Secondary outcome [2] 244821 0
To describe how adverse drug reactions impact on patient well being and ability to manage their affairs using a symptom assessment and impact tool
Timepoint [2] 244821 0
Admission and weekly follow-up for up to 12 weeks or until end February 2010
Secondary outcome [3] 244822 0
To describe the patient?s beliefs about the necessity of the prescribed medication for managing their symptoms and concerns about the potential adverse effects of taking the medicine using the Beliefs about Medicines questionnaire.
Timepoint [3] 244822 0
Admission and weekly follow-up for up to 12 weeks or until end February 2010
Secondary outcome [4] 244823 0
To characterize the potential burden of adverse drug reactions in this setting of multiple concomitant medications and the risk for the prescribing cascade to manage adverse drug reactions. Medication histories from the patient who consent to interview will be utilized.
Timepoint [4] 244823 0
Admission and weekly follow-up for up to 12 weeks or until end February 2010

Eligibility
Key inclusion criteria
All patients consecutively referred to inpatient care at the Phase IV Palliative Care services for the first time and where the referral was either:
1. for direct care with admission to the inpatient unit
2. under the care of another medical specialty, and the service acted in a consultative arrangement, or
3. where care was transferred from another medical specialty to the palliative care service for ongoing management.
Between 1 September to 30 November 2009
4. and who provide informed consent

Patient Interview subset
In addition to above
1. Patients 18 years or older who give informed consent for interviews
2.Australian modified Karnofsky Performance Status (AKPS) is =60 at the time of referral.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patient unable to give consent or for whom it was deemed inappropriate by the Palliative care team to participate in the interview.
2. All patients transferred to other specialty unit within 24 hours of admission to the palliative care service.
3. The patient, their family or the Palliative Care team can withdraw the patient at any time from the study.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment hospital [1] 1841 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [2] 1842 0
Greenwich Hospital - Greenwich
Recruitment hospital [3] 1843 0
Nambour General Hospital - Nambour
Recruitment postcode(s) [1] 7627 0
2065 - Greenwich
Recruitment postcode(s) [2] 7628 0
2065 - St Leonards
Recruitment postcode(s) [3] 7629 0
4560 - Nambour

Funding & Sponsors
Funding source category [1] 237334 0
Government body
Name [1] 237334 0
Australian Government Department of Health and Ageing
Address [1] 237334 0
GPO Box 9848
Canberra
ACT 2601
Country [1] 237334 0
Australia
Primary sponsor type
University
Name
Flinders University
Address
Flinders Drive
Bedford Park
SA 5042
Country
Australia
Secondary sponsor category [1] 236841 0
None
Name [1] 236841 0
Address [1] 236841 0
Country [1] 236841 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239446 0
Northern Sydney Central Coast Health Human Research Ethics Committee
Ethics committee address [1] 239446 0
Level 2, Building 51
Royal North Shore Hospital
St Leonards NSW 2065
Ethics committee country [1] 239446 0
Australia
Date submitted for ethics approval [1] 239446 0
15/07/2009
Approval date [1] 239446 0
07/12/2009
Ethics approval number [1] 239446 0
Not available

Summary
Brief summary
There is a need to quantify the extent and severity of adverse drug reactions in palliative care to inform intervention strategies to reduce the burden of harm and pharmacovigilance as new drug therapies are introduced for the management of symptoms at end of life. This study will review the case notes of all patients admitted to participating palliative care units over a 3 month period, and then to seek permission to interview 30 participants from each site for symptoms, the burden of the symptoms, medications and health service use from the time of admission until death or end of study in February 2010.
1. To analyse the contribution of adverse drug reactions to referrals to Palliative Care Services
2. To determine the nature and frequency of adverse drug reactions in patients referred to palliative care services
3. To explore the relationship between adverse drug reactions and common symptoms experienced in palliative care
4. To undertake patient interview to determine their experience of adverse drug reactions and their perception of the impact of adverse drug reactions. To describe the resource utilisation of those patients in the subset of patients interviewed with the symptoms and index medicines of interest who experience an adverse drug reaction.
Trial website
None
Trial related presentations / publications
In progess.
Public notes

Contacts
Principal investigator
Name 29902 0
A/Prof Debra Rowett
Address 29902 0
Service Director Drug and Therapeutic Information Service (DATIS) Repatriation General Hospital Daws Road DAW PARK SA 5041
Country 29902 0
Australia
Phone 29902 0
+61 8 8275 1179
Fax 29902 0
Email 29902 0
debra.rowett@health.sa.gov.au
Contact person for public queries
Name 13149 0
Ms Belinda Fazekas
Address 13149 0
Palliative Care Clinical Studies Collaborative
Flinders University
700 Goodwood Road
Daw Park
SA 5041
Country 13149 0
Australia
Phone 13149 0
+61 8 8275 1396
Fax 13149 0
Email 13149 0
belinda.fazekas@health.sa.gov.au
Contact person for scientific queries
Name 4077 0
A/Prof Debra Rowett
Address 4077 0
Service Director
Drug and Therapeutic Information Service (DATIS)
Repatriation General Hospital
Daws Road
DAW PARK SA 5041
Country 4077 0
Australia
Phone 4077 0
+61 8 8275 1179
Fax 4077 0
Email 4077 0
debra.rowett@health.sa.gov.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary