ISRCTN ISRCTN75865015
DOI https://doi.org/10.1186/ISRCTN75865015
Protocol serial number PSI10-19
Sponsor Record Provided by the NHS R&D 'Time-Limited' National Programme Register - Department of Health (UK)
Funder NHS Primary and Secondary Care Interface National Research and Development Programme (UK)
Submission date
23/01/2004
Registration date
23/01/2004
Last edited
21/12/2009
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 of protocol

Not provided at time of registration

Contact information

Dr Chris Todd
Scientific

HSRG, General practice and Primary Care Research Unit
Department of Public Health and Primary Care
University of Cambridge
Forvie Site
Robinson Way
Cambridge
CB2 2SR
United Kingdom

Phone +44 (0)1223 330322

Study information

Primary study designInterventional
Study designRandomised controlled trial
Secondary study designRandomised controlled trial
Scientific title
Study objectivesTo evaluate a Hospital at Home (HAH) service for palliative care. Research questions:
1. Compared to standard care
1.1. Was quality of care better under HAH care?
1.2. Were patients more likely to die at home under HAH care?
1.3. Was pattern of other NHS service use different for patients under HAH care?
2. What were health professionals¿ views of HAH?
3. Did the characteristics and care pathways of HAH patients differ from that of other patients?
4. What were the support needs of patients with lung and colorectal cancer who were likely to become eligible for HAH support?
HAH is a service which offers up to 24 hour hands on nursing care in the home, under the medical supervision of the GP, for up to two weeks for adult terminal patients of all diagnoses. It also offers respite care for patients with cancer, MND and AIDS. Factors of interest were place of death, assessment of patient benefits and quality of care under HAH, characteristics and care pathways of patients referred to HAH.
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedSymptoms and general pathology: Pain
Intervention1. Individual Randomised Controlled Trial (RCT) of HAH care versus standard care
2. Survey of health professionals¿ views of HAH, based on pilot study semi-structured interviews
3. Record linkage of electronic data from Cancer Registry, primary and secondary care databases to assess:
3.1. Service use under HAH care versus standard care (incorporated into RCT)
3.2. The characteristics and care pathways of patients referred to HAH versus those not referred
4. Prospective, longitudinal study of colorectal and lung cancer patients eligible for HAH care, and their family carers, beginning when patient care switched from curative to palliative according to hospital
Intervention typeOther
Primary outcome measure(s)

1. Randomised controlled trial: place of death, rated symptom severity and adequacy of care, GP visits, care input from NHS primary and secondary care services during the last two weeks of life
2. Survey: ratings of the importance, benefits and disadvantages of HAH
3. Record linkage: demographic and clinical variables (age, sex, socio-economic status, survival, diagnosis, cause of death), service input variables (contact with oncology services, amount and start date of primary and secondary care NHS input in the last year of life)
4. Longitudinal study: prospective and retrospective expressed need and satisfaction with care, activities of daily living, contacts with health professionals, standard measures of health and quality of life (SF-36, EORTC QLQ-C30), and carer strain (CADI)

Key secondary outcome measure(s)

Not provided at time of registration

Completion date31/12/1999

Eligibility

Participant type(s)Patient
Age groupOther
SexAll
Target sample size at registration229
Key inclusion criteria1. 186 palliative care patients allocated to HAH and 43 palliative control patients. Comparison between HAH and standard care including both primary and secondary NHS input
2. Survey: 78 community nurses, 136 GPs. Assessment of community care only
3. Record linkage: 121 cancer patients referred to HAH, 206 cancer patients not referred to HAH. Both primary and secondary NHS input included
4. Longitudinal study: 54 lung cancer patients, 46 colorectal cancer patients. Both primary and secondary NHS input included.
Key exclusion criteriaDoes not match inclusion criteria
Date of first enrolment01/04/1995
Date of final enrolment31/12/1999

Locations

Countries of recruitment

  • United Kingdom
  • England

Study participating centre

HSRG, General practice and Primary Care Research Unit
Cambridge
CB2 2SR
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 04/12/1999 Yes No