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
Not Applicable
Retrospectively registered
? Protocol not yet added
? SAP not yet added
Results added
? Raw data not yet added
Study completed

Plain English Summary

Not provided at time of registration

Study website

Contact information

Type

Scientific

Contact name

Dr Chris Todd

ORCID ID

Contact details

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
+44 (0)1223 330322

Additional identifiers

EudraCT/CTIS number

IRAS number

ClinicalTrials.gov number

Protocol/serial number

PSI10-19

Study information

Scientific title

Acronym

Study hypothesis

To 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

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Study setting(s)

Not specified

Study type

Not Specified

Patient information sheet

Condition

Symptoms and general pathology: Pain

Intervention

1. 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 type

Other

Primary outcome measure

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)

Secondary outcome measures

Not provided at time of registration

Overall study start date

01/04/1995

Overall study end date

31/12/1999

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. 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.

Participant type(s)

Patient

Age group

Other

Sex

Both

Target number of participants

229

Participant exclusion criteria

Does not match inclusion criteria

Recruitment start date

01/04/1995

Recruitment end date

31/12/1999

Locations

Countries of recruitment

England, United Kingdom

Study participating centre

HSRG, General practice and Primary Care Research Unit
Cambridge
CB2 2SR
United Kingdom

Sponsor information

Organisation

Record Provided by the NHS R&D 'Time-Limited' National Programme Register - Department of Health (UK)

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

NHS Primary and Secondary Care Interface National Research and Development Programme (UK)

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

Individual participant data (IPD) sharing plan

IPD sharing plan summary

Not provided at time of registration

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 04/12/1999 Yes No

Additional files

Editorial Notes