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Trial registered on ANZCTR


Registration number
ACTRN12612000742875
Ethics application status
Approved
Date submitted
10/07/2012
Date registered
11/07/2012
Date last updated
11/02/2021
Date data sharing statement initially provided
11/02/2021
Date results provided
11/02/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
An exploration of the role of pharmacists within general practice clinics: the Pharmacists in Practice Study (PIPS)
Scientific title
A multi-centre, prospective intervention study to explore the role of pharmacists within general practice clinics in optimising medication outcomes in patients at risk of medication-related problems
Secondary ID [1] 280820 0
Nil
Universal Trial Number (UTN)
U1111-1132-5778
Trial acronym
PIPS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Medication-related problems 286888 0
Condition category
Condition code
Public Health 287208 287208 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The pharmacists will provide this intervention over a period of six months at each clinic.

1. Long patient consultations
Participants will receive a 30-60 minute consultation with the pharmacist in a private room at the clinic (or a home visit if they prefer or are housebound) to perform a comprehensive medication review and identify medication-related problems (MRPs). Prior to the consultation, the pharmacist will discuss any health or medication-related issues with the GP or clinic staff, if needed. The pharmacist will also review participants’ general practice medical record (including progress notes, medication lists and pathology results) and dispensing histories if needed. The pharmacist will obtain written informed consent from the participant. In addition to reviewing the participant’s medication regimen, the pharmacist will assess medication adherence and knowledge. The pharmacist will provide counselling and education as needed on medication management and the use of medication devices, and reinforce lifestyle advice related to their health problems and medications. The pharmacist may provide the participant with a complete medication list and refer them to their community pharmacy for adherence aids (e.g. pill boxes, administration aids), if needed. Additionally, referral may be made to the GP or other health professionals as required. After the consultation, the pharmacist will write a short report outlining MRPs and recommendations, and provide this to the participant’s GP either electronically (via secure email or directly into the practice’s electronic medical record) or as a paper-based report, depending on the GP’s preference. The pharmacist may update the medication history within the practice’s medical record as needed. Following this, the pharmacist will discuss any issues with the GP, other staff and community pharmacist, if needed. Case conferencing may be organised where appropriate.

2. Short patient consultations
Patients with potential medication issues (e.g. nonadherence, newly prescribed medicines) who do not require a comprehensive review of their complete medication regimen may receive a short consultation with the pharmacist. Data will be collected about these consultations, but the patients will not be consented for the study (no personal or identifying data will be collected). Referrals may be made by GPs or clinic staff, or patients may self-refer. The short patient consultation will last 15-30 minutes and provides an opportunity for the pharmacist to provide brief education and counselling on specific needs or answer questions. Short patient consultations will only be undertaken in the clinic. After the consultation, the pharmacist will write brief notes directly into the electronic medical record, and update records as needed. Examples of services to be provided in these consultations include: new medication counselling, adherence assessment, assessment of and education on device technique (e.g. using asthma inhalers), and provision of a medication list.

3. Drug information and education service for clinic staff
The practice pharmacist will provide a drug information service for practice staff. Queries can be made to the pharmacist in person, by telephone or via email. All queries (and responses) will be documented by the pharmacist. Practice staff will also be invited to attend pharmacist-led group education sessions targeting topics relevant to them (e.g. new therapy or treatment protocols), and a weekly drug information newsletter may also be produced by the pharmacist and provided to staff.

4. Quality assurance activities
The practice pharmacists will undertake a Drug Use and Evaluation (DUE) program in the clinic. The pharmacists will review current prescribing patterns, evaluate these against current best practice guidelines, and implement an intervention to address deficiencies identified using established DUE methodology. A pharmacotherapeutic area of concern or importance will be identified by the pharmacist in conjunction with the GPs and clinic staff. The practice team, with assistance from the research team, will decide upon audit criteria and measurement instruments will be derived from published clinical practice guidelines. The pharmacist will collect and evaluate data relevant to medication use in this area by retrospectively reviewing electronic medical records. Confidentiality of data will be ensured by de-identifying all information collected. Results and feedback will be provided to staff. Multifaceted strategies to improve the quality of prescribing in the selected area will be developed and implemented by the interdisciplinary team, and re-evaluated at the end of the study period. Patients will not be recruited or consented to this part of the study, and no identifying data will be collected.
Intervention code [1] 285247 0
Other interventions
Comparator / control treatment
No control
Control group
Uncontrolled

Outcomes
Primary outcome [1] 287494 0
Number of medication-related problems will be assessed by pharmacist report, reviewing patient medical records and patient interview.
Timepoint [1] 287494 0
Baseline, 3 months, 6 months
Secondary outcome [1] 298285 0
Medication adherence using Morisky Scale and Tool for Adherence Behaviour Screening (TABS)
Timepoint [1] 298285 0
Baseline, 3 months, 6 months

Eligibility
Key inclusion criteria
Using five or more medicines
Using one or more medicines that require therapeutic drug monitoring (e.g. warfarin, phenytoin, lithium)
Using medicines for three or more medical problems
Have had a recent unplanned hospital admission/emergency department visit
Having other reason(s) for being at risk of medication misadventure (e.g. adherence issues, language barriers, multiple prescribers)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Have had a home medicines review (HMR) in the previous 12 months with no subsequent significant change in clinical status or medication regimen
Are unable to provide written informed consent
Are under 18 years of age
Are unavailable for follow up for six months after recruitment

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients meeting one or more of the eligibility criteria will be considered for referral to the study by their general practitioner or clinic staff. Those patients who are referred to the study will be provided with an introductory letter and plain language statement in person during their clinic visit. Patients will be asked by the GP/clinic staff if they are willing to be contacted by the research team. If patients agree, the GP/clinic staff will provide the research team with the patient’s contact details.

The research assistant will contact patients who agreed to provide their contact details. Suitable and willing participants will be recruited by obtaining initial verbal consent. Written consent will be obtained at the time of the appointment with the practice pharmacist.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/12/2011
Actual
1/12/2011
Date of last participant enrolment
Anticipated
Actual
1/01/2013
Date of last data collection
Anticipated
Actual
1/01/2013
Sample size
Target
50
Accrual to date
Final
82
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 5532 0
3055
Recruitment postcode(s) [2] 5533 0
3031

Funding & Sponsors
Funding source category [1] 285615 0
Charities/Societies/Foundations
Name [1] 285615 0
Windermere Foundation
Country [1] 285615 0
Australia
Primary sponsor type
University
Name
Centre for Medicine Use and Safety, Monash University
Address
Centre for Medicine Use and Safety, Monash University
381 Royal Parade
Parkville
VIC 3052
Country
Australia
Secondary sponsor category [1] 284447 0
None
Name [1] 284447 0
Address [1] 284447 0
Country [1] 284447 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287613 0
Monash University Human Research Ethics Committee
Ethics committee address [1] 287613 0
Ethics committee country [1] 287613 0
Australia
Date submitted for ethics approval [1] 287613 0
Approval date [1] 287613 0
01/04/2008
Ethics approval number [1] 287613 0
2008000201 - CF08/0429

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34423 0
Dr Edwin Tan
Address 34423 0
Pharmacy and Bank Building A15 Science Rd
Country 34423 0
Australia
Phone 34423 0
+61 0286278056
Fax 34423 0
Email 34423 0
edwin.tan@sydney.edu.au
Contact person for public queries
Name 17670 0
Johnson George
Address 17670 0
Centre for Medicine Use and Safety, Monash University
381 Royal Parade
Parkville
VIC 3052
Country 17670 0
Australia
Phone 17670 0
+61-(0)3-9903 9178
Fax 17670 0
+61-(0)3-9903 9629
Email 17670 0
johnson.george@monash.edu
Contact person for scientific queries
Name 8598 0
Johnson George
Address 8598 0
Centre for Medicine Use and Safety, Monash University
381 Royal Parade
Parkville
VIC 3052
Country 8598 0
Australia
Phone 8598 0
+61-(0)3-9903 9178
Fax 8598 0
+61-(0)3-9903 9629
Email 8598 0
johnson.george@monash.edu

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
Dimensions AIAn exploration of the role of pharmacists within general practice clinics: the protocol for the pharmacists in practice study (PIPS)2012https://doi.org/10.1186/1472-6963-12-246
N.B. These documents automatically identified may not have been verified by the study sponsor.