The provision of written information on the management of illness: a cluster randomised trial to examine the impact on primary care services and patient empowerment.

ISRCTN	ISRCTN94837505
DOI	https://doi.org/10.1186/ISRCTN94837505
Protocol serial number	N0096067462
Sponsor	Department of Health
Funder	University of Hertfordshire Research Network (HertNet) / Centre for Research in Primary and Community Care (CRIPACC) (UK)

Submission date: 30/09/2004
Registration date: 30/09/2004
Last edited: 13/08/2010

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 Amanda Platts
Scientific

Parkbury House Surgery
St Peters Street
St Albans
AL1 3HD
United Kingdom

Phone	+44 (0)1727 851589
Email	amanda.platts@gp-e82060.nhs.uk

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	To determine the impact of providing written patient information on the frequency, duration and type of patient contact with the primary healthcare team. To establish the views of both patient and primary care staff on the implications of providing written information in terms of patient empowerment, the patients' level of self care, and the patients' confidence in deciding when to consult a health professional.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Not Applicable: Service delivery
Intervention	The study is a cluster randomised trial. Patients will be allocated to one of the intervention arms or the control arm of the trial by the relevant health professional according to the contents of a prepared unmarked envelope. Patients in the intervention arms will receive a book describing how to best manage by self care or by contact with a health professional a wide range of common illnesses. Information on supplementary sources of health information will also be available. Those in the control group will receive usual care which may include information or other sources of health information.
Intervention type	Other
Primary outcome measure(s)	The primary outcome measures will be the number of contacts (consultations and telephone calls) between the patient and the primary health care team over a one year period. The length of consultation will be logged using data from the computerised appointment system. Semi-structured interviews mine the usefulness of the self care book from both patient and practice perspectives.
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	31/12/2003

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Key inclusion criteria	The patients to be involved in the study will be randomly selected households from the population of 16,500 patients registered with the Parkbury House Surgery. 800 patients will be invited to participate in each intervention arm, and all occupants of each household will be included (approximately 10% of households.)
Key exclusion criteria	Patients under the age of 16 will not be used in the random allocation process, and households in which English is not clearly understood will be excluded as the information to be used in the study is available in English only.
Date of first enrolment	01/04/1998
Date of final enrolment	31/12/2003

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Parkbury House Surgery

St Albans
AL1 3HD
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/09/2005		Yes	No