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
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
-
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.
-
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.