A pilot study of a palliative care intervention for people with advanced dementia

ISRCTN ISRCTN03330837
DOI https://doi.org/10.1186/ISRCTN03330837
Protocol serial number N/A
Sponsor University College London (UK)
Funder BUPA Foundation (UK)
Submission date
30/01/2008
Registration date
25/03/2008
Last edited
27/03/2012
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nervous System Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Martin Blanchard
Scientific

Department of Mental Health Sciences
Royal Free and University College Medical School
Rowland Hill Street
London
NW3 2PF
United Kingdom

m.blanchrad@medsch.ucl.ac.uk

Study information

Primary study designInterventional
Study designA phase IIa pilot study: clustered design with 1 x intervention ward and 1 x control ward
Secondary study designRandomised controlled trial
Study type Participant information sheet
Scientific titleHow can we best provide palliative care in advanced dementia? Phase II development of an intervention: phase IIa pilot study
Study objectivesOur aims are to assess and define the palliative care needs of patients with advanced dementia and their carers and to design and pilot an intervention to improve care.

Objectives:
Our objectives are to:
1. Assess the feasibility of implementing the palliative care needs assessment for patients and advanced care planning for their carers
2. Monitor the consistency of its functional implementation
3. Choose and measure outcomes
4. Examine recruitment rates
5. Assess the feasibility of randomisation
6. Demonstrate acceptable follow-up rates
7. Obtain further views from professionals and patients on the acceptability/practicality of delivering/receiving the intervention
Ethics approval(s)Ethics approval received from the Camden and Islington Local Research Ethics Committee on the 17th December 2007 (ref: 07/H0722/104).
Health condition(s) or problem(s) studiedAdvanced neurodegenerative dementia including Alzheimer's disease, Lewy body and vascular or mixed dementia
InterventionIntervention group:
A structured nurse-led assessment of patients' physical and mental state with particular attention to pain and other features of advanced dementia such as swallowing and mobility. This is coupled with an educative structured discussion with the carer and, if the carer wishes, the construction of an advanced care plan for the patient.

Control group:
Usual hospital clinical care.

The duration of the intervention is a 1 x 1 hour patient assessment and a 2 x 1 hour care planning discussion with the patients main family carer. Follow up for both arms is six months. Assessment of outcomes will occur at six weeks, then six months. If the subject dies during the study period, their final hospital admission will be audited and their carer interviewed at three months post-bereavement.
Intervention typeOther
Primary outcome measure(s)

This is a pilot study and a number of potential outcomes will be explored:

Carer related outcomes:
1. Stress and wellbeing-Kessler Distress Scale (KD10)
2. Health status (EQ-5D)
3. Satisfaction with decision-making process:
3.1. Decision Satisfaction Inventory
3.2. Decision Conflicts Scale
4. Satisfaction with care: Satisfaction with End of Life Care in Advanced Dementia Scale
5. Visual Analogue Scale: a standard 10 cm Visual Analogue Scale to measure carer satisfaction with:
5.1. The process of the advanced care planning
5.2. The utility/usefulness of the advance care planning

Patient related outcomes:
1. Active interventions: Painful Interventions Scale
2. Other interventions:
2.1. Resuscitation status
2.2. Percutaneous endoscopic gastrostomy (PEG) feeding
2.3. Prescription of neuroleptics
3. Quality of end of life care:
3.1. Prescription of analgesia at time of death
3.2. Use of Liverpool Care Pathway
4. Survival times: time of intervention to time of death

System related outcomes:
1. Advanced care planning:
1.1. Numbers choosing to make advanced care plan
1.2. Adherence to advance care plan
2. Use of Gold Standards Framework (GSF): by GP (if practice participating in the GSF programme)
3. Referrals to and input from community palliative care
4. Number of contacts after the intervention, i.e., by telephone between carers and the research nurse
5. Readmission rates for emergency acute admissions
6. Place of death
7. Economic outcomes (Client Service Receipt Inventory [CSRI])

Key secondary outcome measure(s)

No secondary outcome measures as this is a pilot study, therefore only the establishment of which outcomes are of most utility is being explored.

Completion date02/08/2008

Eligibility

Participant type(s)Patient
Age groupSenior
SexAll
Target sample size at registration40
Key inclusion criteriaWe will recruit patients who have a high six-month mortality risk:
1. Unplanned emergency admission to general hospital ward with treatable acute medical illness
2. Over 70 years of age, either sex
3. Diagnosis of advanced primary degenerative dementia:
3.1. Functional assessment staging (FAST) stage 6e or worse
3.2. Doubly incontinent and needing assistance with all activities of daily living
Key exclusion criteria1. Imminently dying (prognosis less than 48 hours)
2. Patients without a clearly identified non-statutory carer
Date of first enrolment02/02/2008
Date of final enrolment02/08/2008

Locations

Countries of recruitment

  • United Kingdom
  • England

Study participating centre

Department of Mental Health Sciences
London
NW3 2PF
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 11/07/2008 Yes No
Participant information sheet Participant information sheet 11/11/2025 11/11/2025 No Yes
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