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

Not Applicable

Completed

• Conditions: Palliative care admissions; Other - Conditions of unknown or disputed aetiology (such as chronic fatigue syndrome/myalgic encephalomyelitis)

• Registration Number: ACTRN12609000599279
• Lead Sponsor: Flinders University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-07-20
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.<br>The Naranjo scale will be used to assess probability of an ADR.<br>Causality and classification will be assessed using the Scale by Edwards and Aronson (Lancet 2000).<br>Severity of the ADR will be assessed using the World Health Organisation Adverse Reaction Terminology (WHO-ART).[Admission to palliative care]