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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
ClinicalTrials.gov identifier
Public title 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.
Scientific title
Acronym N/A
Serial number at source N0096067462
Study hypothesis 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 Not provided at time of registration
Study design Randomised controlled trial
Countries of recruitment United Kingdom
Disease/condition/study domain Not Applicable: Service delivery
Participants - 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.)
Participants - 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.
Anticipated start date 01/04/1998
Anticipated end date 31/12/2003
Status of trial Completed
Patient information material
Target number of participants Not provided at time of registration
Interventions 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.
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.
Secondary outcome measure(s) Not provided at time of registration
Sources of funding University of Hertfordshire Research Network (HertNet) / Centre for Research in Primary and Community Care (CRIPACC) (UK)
Trial website
Publications 2005 results in http://www.ncbi.nlm.nih.gov/pubmed/16162465
Contact name Dr  Amanda  Platts
  Address Parkbury House Surgery
St Peters Street
  City/town St Albans
  Zip/Postcode AL1 3HD
  Country United Kingdom
  Tel +44 (0)1727 851589
  Fax +44 (0)1727 854372
  Email amanda.platts@gp-e82060.nhs.uk
Sponsor Record Provided by the NHSTCT Register - 2004 Update - Department of Health (UK)
  Address The Department of Health,
Richmond House,
79 Whitehall
  City/town London
  Zip/Postcode SW1A 2NL
  Country United Kingdom
  Tel +44 (0)20 7307 2622
  Email dhmail@doh.gsi.org.uk
  Sponsor website: http://www.dh.gov.uk/Home/fs/en
Date applied 30/09/2004
Last edited 13/08/2010
Date ISRCTN assigned 30/09/2004
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