Condition category
Mental and Behavioural Disorders
Date applied
21/09/2006
Date assigned
17/10/2006
Last edited
11/07/2011
Prospective/Retrospective
Retrospectively 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

Prof Carmel M Hughes

ORCID ID

Contact details

School of Pharmacy
Medical Biology Centre
97 Lisburn Road
Belfast
BT7 9BL
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

EAT2528/03

Study information

Scientific title

Acronym

Fleetwood (N.I.) Project

Study hypothesis

This project aims to answer the following questions:
1. Can an adapted US model of care (the Fleetwood model) improve psychoactive prescribing and reduce falls in nursing home residents in Northern Ireland?
2. Does healthcare resource usage (i.e. direct healthcare costs) change as a result of the implementation of the Fleetwood model?

Ethics approval

Ethical approval for the study has been obtained from the Research Ethics Committee 2 of the Office for the Research Ethics Committees, Northern Ireland, date of approval: 15th August 2005 (reference number: 05/NIR02/112).

Study design

Cluster randomised controlled trial (12 month duration)

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Quality of life

Patient information sheet

Condition

This intervention aims to improve the psychoactive prescribing for residents in nursing homes. It is not disease specific.

Intervention

The intervention being tested is an adapted US model of pharmaceutical care - the Fleetwood model. This care model is provided to intervention home residents by pharmacists who have received specialist training in medicines for older people. It consists of monthly visits to nursing homes and includes the following steps:
1. Assessment of residents’ pharmaceutical care needs
2. Medication review
3. Preparation of a pharmaceutical care plan that is shared between the relevant healthcare personnel
4. Pharmacist intervention and direct communication with the prescriber

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

The primary outcomes for this trial will be a change in the prevalence of inappropriate psychoactive drug use and the number of residents who fall in the intervention homes compared to the control sites, over the 12 month study period. At three, six and 12 months, equivalent data as per baseline (excluding patient demographic data) will be collected using documentation provided by the US trial investigators and adapted for use in the present study, in addition to the number and length of pharmacist consultations (intervention group only).

Secondary outcome measures

It has been shown that patients on psychoactive medication are more likely to fall, incurring additional costs to health care systems. Therefore, a secondary outcome of this study will be to examine and quantify the changes in resource usage as a result of the implementation of the modified Fleetwood model. Direct medical (healthcare) costs for both intervention and control patients will be calculated using the framework outlined by Drummond et al. (2000). The evaluation will be performed from the perspective of the payer: direct non-medical, indirect and intangible costs will not be estimated.

Cost estimates will be calculated using data collected at baseline and throughout the intervention period (e.g. hospitalisations, number of consultations), in conjunction with national accounting statistics representative of unit costs surveyed across the United Kingdom. The cost of patient drugs will be obtained from the standard Drug Tariff. Resource use data will be collected for 12 months prior to baseline and for 365 days (to standardise calculation of unit costs) after enrolment or until death. Mean annual cost estimates for each type of resource group will be shown separately (e.g. drug cost, hospitalisations, General Practitioner visits) and compared pre- and post-enrolment and by allocation to control or intervention group.

A secondary outcome to be evaluated in this study will be professional satisfaction of intervention prescribing support pharmacists, GPs and nurses (of intervention residents) with the programme. This will be assessed using postal questionnaires.

Overall trial start date

01/04/2006

Overall trial end date

31/08/2007

Reason abandoned

Eligibility

Participant inclusion criteria

Eleven matched pairs of nursing homes were selected at random from all those in Northern Ireland with greater than 30 beds, which consented to participate in the project. Within each home, all residents aged more than 65 years were invited to participate. Where appropriate, their next-of-kin were approached for consent to participate.

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

330

Participant exclusion criteria

Residents were excluded if they were terminally ill, in a coma or if no consent was obtained.

Recruitment start date

01/04/2006

Recruitment end date

31/08/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

School of Pharmacy
Belfast
BT7 9BL
United Kingdom

Sponsor information

Organisation

Queen's University Belfast (UK)

Sponsor details

Research and Regional Services Department
Lanyon North
University Road
Belfast
BT7 1NN
United Kingdom
+44 (0)28 9097 5800
rrs@qub.ac.uk

Sponsor type

University/education

Website

http://www.qub.ac.uk/rrs

Funders

Funder type

Government

Funder name

Research and Development Office for the Health & Personal Social Services (UK) (reference no: EAT/2528/03)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

1. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20002510
2. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21453379

Publication citations

  1. Results

    Patterson SM, Hughes CM, Crealey G, Cardwell C, Lapane KL, An evaluation of an adapted U.S. model of pharmaceutical care to improve psychoactive prescribing for nursing home residents in northern ireland (fleetwood northern ireland study)., J Am Geriatr Soc, 2010, 58, 1, 44-53, doi: 10.1111/j.1532-5415.2009.02617.x.

  2. Results

    Patterson SM, Hughes CM, Cardwell C, Lapane KL, Murray AM, Crealey GE, A cluster randomized controlled trial of an adapted U.S. model of pharmaceutical care for nursing home residents in Northern Ireland (Fleetwood Northern Ireland study): a cost-effectiveness analysis., J Am Geriatr Soc, 2011, 59, 4, 586-593, doi: 10.1111/j.1532-5415.2011.03354.x.

Additional files

Editorial Notes