Improving the provision of palliative services: A randomised controlled trial of the use of enhanced primary care items and educational interventions - the Palliative Care Trial
| ISRCTN | ISRCTN81117481 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN81117481 |
| Secondary identifying numbers | N/A |
- Submission date
- 29/05/2003
- Registration date
- 23/07/2003
- Last edited
- 23/06/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English Summary
Not provided at time of registration
Contact information
Dr Amy Abernethy
Scientific
Scientific
Southern Adelaide Palliative Services
700 Goodwood Road
Daw Park
5041
Australia
| Phone | +61 8 8275 1732 |
|---|---|
| amy.abernethy@duke.edu |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Quality of life |
| Scientific title | Improving the provision of palliative services: A randomised controlled trial of the use of enhanced primary care items and educational interventions - the Palliative Care Trial |
| Study 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(s) | All 13 relevant independent human research ethics committees and institutional review boards approved the PCT. |
| 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 |
| Primary outcome measure | 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 study start date | 15/04/2002 |
| Overall study end date | 30/11/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Not Specified |
| Target number of participants | 461 |
| Total final enrolment | 461 |
| 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 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
Study participating centre
Southern Adelaide Palliative Services
Daw Park
5041
Australia
5041
Australia
Sponsor information
Repatriation General Hospital (Australia)
Hospital/treatment centre
Hospital/treatment centre
Southern Adelaide Palliative Services
700 Goodwood Road
Daw Park
5041
Australia
"ROR" |
https://ror.org/04b0n4406 |
|---|
Funders
Funder type
Government
Commonwealth Department of Health and Ageing (Australia)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Other publications | Performance measure results | 12/11/2005 | Yes | No | |
| Protocol article | protocol | 01/02/2006 | Yes | No | |
| Results article | 24/10/2012 | 23/06/2022 | Yes | No |
Editorial Notes
23/06/2022: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
