Skip to content

A prospective observational study - understanding the burden of adverse drug reactions and their impact on symptoms at end of life

A prospective observational study - understanding the burden of adverse drug reactions and their impact on symptoms at end of life in palliative care patients.

Status
Completed
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12609000599279
Enrollment
120
Registered
2009-07-20
Start date
2009-12-15
Completion date
2010-03-31
Last updated
2020-01-13

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

Conditions

None listed

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.

Interventions

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

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.

Sponsors

Flinders University
Lead SponsorUniversity

Eligibility

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

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.

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026