Randomised Evaluation of Shared Prescribing for Elderly people in the Community over Time
| ISRCTN | ISRCTN16932128 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16932128 |
| Secondary identifying numbers | G0001150 |
- Submission date
- 02/05/2001
- Registration date
- 02/05/2001
- Last edited
- 19/12/2017
- 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 Ian Wong
Scientific
Scientific
School of Pharmacy
University of London
Brunswick Square
London
WC1N 1AX
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Scientific title | Randomised Evaluation of Shared Prescribing for Elderly people in the Community over Time |
| Study acronym | RESPECT |
| Study objectives | 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? |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Primary care |
| Intervention | 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. |
| Intervention type | Other |
| Primary outcome measure | Medication Appropriateness Index (Validated for the UK). |
| Secondary outcome measures | 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. |
| Overall study start date | 01/02/2002 |
| Completion date | 28/02/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 760 |
| Key inclusion criteria | 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. |
| Key exclusion criteria | 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. |
| Date of first enrolment | 01/02/2002 |
| Date of final enrolment | 28/02/2006 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
School of Pharmacy
London
WC1N 1AX
United Kingdom
WC1N 1AX
United Kingdom
Sponsor information
Medical Research Council (MRC) (UK)
Research council
Research council
20 Park Crescent
London
W1B 1AL
United Kingdom
| Phone | +44 (0)20 7636 5422 |
|---|---|
| clinical.trial@headoffice.mrc.ac.uk | |
| Website | http://www.mrc.ac.uk |
Funders
Funder type
Research council
Medical Research Council (UK)
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- Medical Research Council (United Kingdom), UK Medical Research Council, MRC
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 07/06/2004 | Yes | No | |
| Results article | cost effectiveness results | 01/01/2010 | Yes | No | |
| Results article | effectiveness results: | 01/01/2010 | Yes | No |
Editorial Notes
19/12/2017: Publication references added.
