Condition category
Not Applicable
Date applied
29/05/2003
Date assigned
23/07/2003
Last edited
27/03/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Amy Abernethy

ORCID ID

Contact details

Southern Adelaide Palliative Services
700 Goodwood Road
Daw Park
5041
Australia
+61 8 8275 1732
amy.abernethy@duke.edu

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

PCT

Study hypothesis

The Palliative Care Trial (PCT) is a pragmatic 2 x 2 x 2 factorial cluster randomized controlled trial that tests the ability of educational outreach visiting and case conferencing to improve patient-based outcomes such as performance status and pain intensity.

Ethics approval

All 13 relevant independent human research ethics committees and institutional review boards approved the PCT.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Quality of life

Patient information sheet

Condition

Palliative Care

Intervention

461 consenting patients and their GPs were enrolled into a randomised controlled trial set up in a 2x2x2 factorial clustered design of:

- A coordinated palliative care model centred on case conferencing versus the standard model of palliative care in Adelaide (3:1 randomisation).

- Educational outreach visiting for the patient's GP, versus the routine teaching currently offered by the service (1:1 randomisation).

- Educational outreach visiting for the patient, versus the routine teaching currently offered by the service (1:1 randomisation).

An interaction term from the 2x2 analysis of GP education and patient education allows evaluation of the interaction between these two interventions.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Randomisation 1: performance status on the Australian-modified Karnofsky Performance Status Scale
Randomisations 2 & 3: pain intensity on a 0-10 visual analogue scale (VAS)

Secondary outcome measures

Other outcome measures include control of other symptoms, health resource utilization, and quality of life.

Overall trial start date

15/04/2002

Overall trial end date

30/11/2004

Reason abandoned

Eligibility

Participant inclusion criteria

Because an aim of this study was to improve specialized palliative healthcare delivery, the eligibility criteria were broad. All adult patients referred to the Southern Adelaide Palliative Services with any form of pain in the preceding 3 months were eligible after providing written informed consent. Participants were mentally competent at enrollment (Folstein Mini-Mental State Examination Score ≥24).

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

461

Participant exclusion criteria

Patients who were expected to die within 48 hours of referral and who lived out of the geographic region served by the team were excluded.

Recruitment start date

15/04/2002

Recruitment end date

30/11/2004

Locations

Countries of recruitment

Australia

Trial participating centre

Southern Adelaide Palliative Services
Daw Park
5041
Australia

Sponsor information

Organisation

Repatriation General Hospital (Australia)

Sponsor details

Southern Adelaide Palliative Services
700 Goodwood Road
Daw Park
5041
Australia

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

Commonwealth Department of Health and Ageing (Australia)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2005 performance measure results at http://www.ncbi.nlm.nih.gov/pubmed/16283937
2. 2006 protocol in http://www.ncbi.nlm.nih.gov/pubmed/16290094
3. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19318461

Publication citations

  1. Performance measure results at

    Abernethy AP, Shelby-James T, Fazekas BS, Woods D, Currow DC, The Australia-modified Karnofsky Performance Status (AKPS) scale: a revised scale for contemporary palliative care clinical practice [ISRCTN81117481]., BMC Palliat Care, 2005, 4, 7, doi: 10.1186/1472-684X-4-7.

  2. Protocol

    Abernethy AP, Currow DC, Hunt R, Williams H, Roder-Allen G, Rowett D, Shelby-James T, Esterman A, May F, Phillips PA, A pragmatic 2 x 2 x 2 factorial cluster randomized controlled trial of educational outreach visiting and case conferencing in palliative care-methodology of the Palliative Care Trial [ISRCTN 81117481]., Contemp Clin Trials, 2006, 27, 1, 83-100, doi: 10.1016/j.cct.2005.09.006.

  3. Results

    Agar M, Currow D, Plummer J, Seidel R, Carnahan R, Abernethy AP, Changes in anticholinergic load from regular prescribed medications in palliative care as death approaches., Palliat Med, 2009, 23, 3, 257-265, doi: 10.1177/0269216309102528.

Additional files

Editorial Notes