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ISRCTN
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ISRCTN16932128
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DOI
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10.1186/ISRCTN16932128
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ClinicalTrials.gov identifier
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EudraCT number
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Public title
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Randomised Evaluation of Shared Prescribing for Elderly people in the Community over Time
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Scientific title
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Acronym
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RESPECT
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Serial number at source
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G0001150
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Study hypothesis
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Principal research questions to be addressed:
1. Is shared pharmaceutical care for elderly people in the community effective in:
1.1 improving the quality of prescribing?
1.2 improving patient's knowledge about their disease and medication?
1.3 improving compliance?
1.4 reducing adverse events?
1.5 and thus improving quality of life?
2. Is shared pharmaceutical care for elderly people in the community cost-effective?
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Primary care
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Participants - inclusion criteria
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Patients aged more than 75 years with repeat prescriptions for five or more drugs (excluding drugs taken only when required), who are living at home, well oriented in time and place, and able to give their consent to take part. Their GPs' consent is also necessary.
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Participants - exclusion criteria
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Patients in residential or nursing homes. Patients who took part in our feasibility study of vulnerable elderly people or who normally use a pharmacy which has refused to participate in the trial. Patients with dementia who score 6 or below on the Abbreviated Mental Test.
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Anticipated start date
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01/02/2002
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Anticipated end date
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28/02/2006
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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760
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Interventions
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General practices, pharmacies and patients will be grouped according to the Primary Care Trust to which they belong. These five groups will begin the intervention (pharmaceutical care) in five successive phases, the order of which will be randomly determined. All five will act as controls until the intervention begins, e.g. community pharmacists will provide their usual dispensing services during this 'control period'.
The experimental intervention is pharmaceutical care (PC), in which pharmacists co-operate with doctors, patients and carers in designing, implementing and monitoring a pharmaceutical care plan (PCP). GPs and community pharmacists in the same PCT are asked to attend the same training block. This consists of one workshop for community pharmacists on PC for the elderly and one joint workshop for pharmacists and GPs on how to work together. These workshops encourage a problem-based approach to the application of pharmaceutical care.
Once trained, community pharmacists meet recruited patients and follow a specific step by step procedure advocated for the development of a PCP. In addition pharmacists educate patients and, if appropriate, carers about the indication for each medication and its use, and withdraw unwanted medicines with patients' consent. If patients need compliance aids such as dosette boxes or reminder charts, the pharmacists provide these services. They continue to update and implement the PCP, and monitor outcome at least monthly in association with patients and their GPs.
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Primary outcome measure(s)
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Medication Appropriateness Index (Validated for the UK).
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Secondary outcome measure(s)
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Patients' knowledge, compliance and concordance, practice-reported (and therefore more serious) adverse events, and self-assessed health outcome.
Economic: Cost of treatment to NHS, patients and society as a whole.
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Sources of funding
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Medical Research Council (UK)
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Trial website
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Publications
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Study protocol: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=15182379
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Contact name
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Dr
Ian
Wong
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Address
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School of Pharmacy
University of London
Brunswick Square
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City/town
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London
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Zip/Postcode
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WC1N 1AX
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Country
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United Kingdom
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Email
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Sponsor
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Medical Research Council (MRC) (UK)
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Address
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20 Park Crescent
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City/town
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London
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Zip/Postcode
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W1B 1AL
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Country
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United Kingdom
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Tel
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+44 (0)20 7636 5422
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Fax
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+44 (0)20 7436 6179
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Email
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clinical.trial@headoffice.mrc.ac.uk
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Sponsor website:
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http://www.mrc.ac.uk
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Date applied
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02/05/2001
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Last edited
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06/08/2008
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Date ISRCTN assigned
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02/05/2001
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