Condition category
Not Applicable
Date applied
02/05/2001
Date assigned
02/05/2001
Last edited
06/08/2008
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Ian Wong

ORCID ID

Contact details

School of Pharmacy
University of London
Brunswick Square
London
WC1N 1AX
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

G0001150

Study information

Scientific title

Acronym

RESPECT

Study hypothesis

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

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

01/02/2002

Overall trial end date

28/02/2006

Reason abandoned

Eligibility

Participant 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.

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

760

Participant 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.

Recruitment start date

01/02/2002

Recruitment end date

28/02/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

School of Pharmacy
London
WC1N 1AX
United Kingdom

Sponsor information

Organisation

Medical Research Council (MRC) (UK)

Sponsor details

20 Park Crescent
London
W1B 1AL
United Kingdom
+44 20 7636 5422
clinical.trial@headoffice.mrc.ac.uk

Sponsor type

Research council

Website

http://www.mrc.ac.uk

Funders

Funder type

Research council

Funder name

Medical Research Council (UK)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Study protocol: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=15182379

Publication citations

  1. Study protocol

    Wong I, Campion P, Coulton S, Cross B, Edmondson H, Farrin A, Hill G, Hilton A, Philips Z, Richmond S, Russell I, Pharmaceutical care for elderly patients shared between community pharmacists and general practitioners: a randomised evaluation. RESPECT (Randomised Evaluation of Shared Prescribing for Elderly people in the Community over Time) [ISRCTN16932128]., BMC Health Serv Res, 2004, 4, 1, 11, doi: 10.1186/1472-6963-4-11.

Additional files

Editorial Notes