Condition category
Respiratory
Date applied
05/01/2015
Date assigned
14/01/2015
Last edited
06/07/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Cognitive pharmaceutical services are defined as the use of specialised knowledge by pharmacists for the promotion of effective and safe use of drugs by patients. I-MUR is the first cognitive pharmaceutical service tested and introduced in Italy. The aim of this study is to assess the clinical and economic effects of I-MUR interventions provided by Italian community pharmacists to patients with asthma. The RE I-MUR study is the third phase of a research and development project. Phase one was done between October 2012 and January 2013 to assess the feasibility of community pharmacists delivering I-MUR, which was new for Italy. Phase two was done between October 2013 and November 2013 to obtain feedback from patients and general practitioners.

Who can participate?
Patients with asthma, aged at least 18

What does the study involve?
Pharmacists are allocated to one of two groups.
Group A pharmacists will deliver I-MUR to patients at the beginning of the study and group B pharmacists will deliver the intervention at 3 months during private consultations. Patients, once enrolled in the study, will meet their pharmacists four times (every 3 months) during 9 months. During each meeting, pharmacists will invite patients to complete the Asthma Control Test, identify the number of medicines used by patients and assess patients’ adherence to treatment.

What are the possible benefits and risks of participating?
There will be no risks for the patients. Patients receiving the I-MUR service will be at no greater risk than patients receiving usual clinical care.

Where is the study run from?
Ten centres covering 15 Italian regions from the north to the south of Italy: Trentino Alto Adige, Lombardia, Sicilia, Puglia, Sardegna, Piemonte, Valle d’Aosta, Veneto, Friuli Venezia Giulia, Toscana, Emilia, Marche, Abruzzo, Lazio and Campania.

When is the study starting and how long is it expected to run for?
September 2014 to June 2015

Who is funding the study?
Italian Pharmacists' Federations (Federazione Ordini Farmacisti Italiani)

Who is the main contact?
Andrea Manfrin
a.manfrin@kent.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Andrea Manfrin

ORCID ID

Contact details

University of Greenwich and Kent at Medway
Anson Building
Central Avenue
Chatham Maritime
Chatham
ME4 4TB
United Kingdom
+44 (0)1634 202 948
a.manfrin@kent.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

0281314

Study information

Scientific title

Randomised Evaluation of the Italian Medicines Use Review provided by community pharmacists using asthma as a model

Acronym

RE I-MUR

Study hypothesis

Null hypothesis: the I-MUR service (aimed at optimising the number of medicines used by patients, identifying the number of pharmaceutical care issues and improving patients’ adherence to asthma medications) provided by community pharmacists does not affect the severity of asthma, as measured with the Asthma Control Test score.
Alternative hypothesis: I-MUR has an impact on the severity of asthma.

Ethics approval

1. Faculty of Science Ethics Committee of the University of Kent (UK) (Faculty of Sciences Research Ethics Advisory Group for Human Participants on 18 February 2014 with reference number 0281314
2. Ethics Committee of Spedali Civili di Brescia (Lombardia regions), which is the reference centre for all Italian participating regions, on 3 June 2014 with reference number NP 1710

Study design

Cluster-randomised controlled trial, with each pharmacist representing a cluster. Community pharmacists, stratified by the region of Italy, will be randomly assigned to one of two groups (A and B).

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Community

Trial type

Other

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Asthma

Intervention

The I-MUR intervention covers patients’ demographics, their regular medications including those used for asthma, patients’ attitudes towards their medications and adherence to treatments, pharmaceutical care issues identified by the pharmacists, pharmacists’ advice given to patients including healthy living advice, pharmacists’ advice given to doctors, pharmacists’ own views on the potential benefit to the patient of the I-MUR service.

Community pharmacists, stratified by the region of Italy, will be randomly assigned to one of two groups (A or B). Each pharmacist will recruit five patients. Group A pharmacists will deliver I-MUR to patients at the beginning of the study and group B pharmacists will deliver the intervention at 3 months. Pharmacists will administer the Asthma Control Test before I-MUR and at 6 months and 9 months in each group. Patients will be followed up at 3 months and 6 months. After each consultation, pharmacists will enter the results into a web-based template, maintaining the anonymity of patients.

Intervention type

Other

Phase

Drug names

Primary outcome measures

Severity of asthma, assessed with the Asthma Control Test score

Secondary outcome measures

1. Number of active ingredients used by patients, as reported by patients
2. Number of pharmaceutical care issues identified during provision of the I-MUR service
3. Patients’ adherence to asthma medication during and after the I-MUR service provision, measured with questions embedded in the I-MUR instrument
4. Overall health-care costs, estimated on the basis of the severity of asthma, before, during and after provision of the I-MUR service

Overall trial start date

01/09/2014

Overall trial end date

30/06/2015

Reason abandoned

Eligibility

Participant inclusion criteria

Pharmacies must have:
1. An area for private consultation with patients
2. Internet connection at the place of the consultation

Pharmacists must:
1. Be qualified and registered with the Italian Pharmacy Board practicing in Italy
2. Have at least 1 year of experience in providing advice to patients
3. Already provide one or more services such as blood pressure monitoring, smoking cessation, cholesterol monitoring, signposting and food intolerance testing to demonstrate advanced consultation skills and experience
4. Be able to attend training sessions

Patient selection will take place over the same defined period for all 360 pharmacists: before baseline. Patients will be identified by pharmacists from their medication history, from their prescriptions, or by referral from general practitioners, according to inclusion and exclusion criteria:
1. Age at least 18 years old
2. Diagnosed with asthma, for at least 6 months before enrolment to the study
3. Have at least one prescription for asthma medication with the Anatomical, Therapeutic Chemical Classification R03: drugs for obstructive airways disease

Participant type

Mixed

Age group

Adult

Gender

Both

Target number of participants

360 community pharmacists and 1800 patients

Participant exclusion criteria

Pharmacies do not have:
1. Internet access
2. Consultation room

Pharmacists:
1. Involved in any other clinical pharmacy research project

Patients:
1. Have terminal illness (an advanced stage of a disease with an unfavourable prognosis and no known cure) as identified by the pharmacists through the prescription coding
2. Are currently enrolled in another clinical trial
3. Do not self-administer their inhaler
4. Do not have the ability to communicate well in Italian (both verbally and in writing)

Recruitment start date

01/09/2014

Recruitment end date

31/10/2014

Locations

Countries of recruitment

Italy

Trial participating centre

15 Italian regions
-
Italy

Sponsor information

Organisation

FOFI (Italian Pharmacists' Federation = Federazione Ordini Farmacisti Italiani)

Sponsor details

Via Palestro 75
Rome
00185 Rome
Italy
+39 (0) 6 4450361
posta@pec.fofi.it

Sponsor type

Other

Website

http://www.fofi.it/

Funders

Funder type

Other

Funder name

FOFI (Italian Pharmacists' Federation = Federazione Ordini Farmacisti Italiani)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

To be confirmed at later date

Intention to publish date

01/01/2016

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

2015 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/25896873

Publication citations

Additional files

Editorial Notes

06/07/2016: Publication reference added.