Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000427279
Ethics application status
Approved
Date submitted
20/03/2009
Date registered
10/06/2009
Date last updated
6/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Pharmacist Prescribing in a Sexual Health and Human Immunodeficiency Virus (HIV) Outpatient Clinic
Scientific title
The Evaluation of the Impacts of a Doctor – Pharmacist Collaborative Prescribing Model on the Management of Human Immunodeficiency Virus (HIV) Infected Patients
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Human Immunodefiency Virus (HIV) 4511 0
Condition category
Condition code
Infection 4792 4792 0 0
Acquired immune deficiency syndrome (AIDS / HIV)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Management of previously diagnosed and stable HIV patients, under an agreed care plan between consultant sexual health physician, pharmacist and patient
Patient appointments are approximately half an hour, and scheduled routinely every 3 months. The intervention will run until all patients in the intervention arm have been seen twice by the pharmacist after the production of the initial care plan, so for approximately 6 months after care plan production for each patient.
Intervention code [1] 4262 0
Treatment: Other
Comparator / control treatment
Usual care, control patients will be seen by their usual sexual health physician for the duration of the study
Patient appointments are approximately half an hour, and scheduled routinely every 3 months.
Usual care for the purposes as a control will be administered for the same time period as the intervention runs for, namely Appointment 1 is informed consent and randomisation, appointment 2 is production of a care plan for intervention patients and usual care for control, appointment 3 is being seen by the pharmacist for intervention patients and usual care for control and appointment 4 is being seen by the pharmacist for the second time for intervention patients and usual care for control. So from recruitment to end of 4th appointment is 9 months
Control group
Active

Outcomes
Primary outcome [1] 5652 0
The effective ongoing management of previously diagnosed and stable HIV patients by the pharmacist prescriber.
An audio recording of all doctor and pharmacist consultations with patients will be made. The recordings will be transcribed and analysed using Leximancer. The completeness of information gathered to enable ongoing treatment decisions to be made will be assessed using the Medication Related Consultation Framework.
Leximancer text analysis software extracts concepts from text independent of coder biases. A thesaurus is built from the dataset containing concepts derived from the document(s) according to the proximity and frequency of word co-occurrences in the text. Leximancer produces a two dimensional pictorial representation of a multidimensional matrix. The size of the dot associated with a concept represents its frequency in the analysed text. The proximity of the concepts on the map indicates the co-occurrence proximity with other concepts in the text analysed. Automatic coding can process large amounts of text, and provides coding standardization which has been validated against standard tests and manual coding software.

Evaluation of Process of Care

Case files will be compiled for a selection of patients throughout the study and 50% from each arm will be randomly selected and assessed by an independent, multi-disciplinary panel at the end of the study.
A panel will be convened that ideally consists of 2 independent sexual health physicians, 2 independent HIV/sexual health pharmacists and 2 independent HIV/sexual health nurses.
Using consensus methods, the panel will assess the appropriateness of the patient's ongoing management and degree of care plan compliance, including:

-disease progress and control
-symptoms and management
-management of side effects
-appropriateness of dose adjustments
-appropriateness of medication changes
-appropriateness of referrals

Evaluation of Patient Adherence with Medication

Patients' level of adherence with medication regimens will be assessed via three different methods:
-viral load and CD4 counts
-from dispensing records and frequency of medication collection
-via a self-reported adherence questionnaire
Timepoint [1] 5652 0
6. 9 and 12 months following recruitment of the patient into the study
Secondary outcome [1] 241539 0
A reduction in the burden on medical staff within the clinic with regards to patient access
Sexual health physician appointments throughout the study will be timed, using the recording made on the MP3 player , and averaged out to assess how much physician time may be released as a result of the pharmacist seeing patients under an agreed care plan.
Any change in waiting list time to access an appointment at the clinic to see a prescriber will also be assessed as a measure of increased access for patients to medical staff.
The average length of time from ringing for an appointment to obtaining an appointment can be obtained from the electronic appointment system in the clinic. Data will be assessed for a month within the project, August 2009, and compared to the same month of the previous year, August 2008.
Timepoint [1] 241539 0
6, 9 and 12 months following recruitment of the patient into the study

Eligibility
Key inclusion criteria
Previously diagnosed and stable HIV patients, as determined by their usual sexual health physician
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
New patients to the clinic, without a diagnosis.
Transient patients visiting the clinic from outside of the health district.
Patients currently participating in clinical drug trials.
Patients having prescriptions dispensed interstate
Patients having pathology testing performed by private laboratories

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients with a diagnosis of HIV infection, who have had a prior medical assessment and are stable in terms of disease, will be considered for participation in the study.

Patients identified as suitable for participation will be seen by their usual sexual health physician at their next regular appointment and be provided with an information leaflet about the study and given the opportunity to ask any questions. If patients are happy to participate, they will be asked to provide written and informed consent.

Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomization using randomization created by a computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
12/03/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4697 0
Government body
Name [1] 4697 0
Medication Services Queensland
Country [1] 4697 0
Australia
Funding source category [2] 4698 0
Government body
Name [2] 4698 0
Office of the Chief Health Officer, Qld Health
Country [2] 4698 0
Australia
Primary sponsor type
Government body
Name
Medication Services Queensland
Address
RBWH,
Block 7, Level 13,
Herston Road
Herston,
Brisbane,
Queensland
4006
Country
Australia
Secondary sponsor category [1] 4243 0
None
Name [1] 4243 0
Address [1] 4243 0
Country [1] 4243 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6733 0
Gold Coast Health Service District Ethics Committee
Ethics committee address [1] 6733 0
Ethics committee country [1] 6733 0
Australia
Date submitted for ethics approval [1] 6733 0
Approval date [1] 6733 0
16/01/2009
Ethics approval number [1] 6733 0
200895

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

Contacts
Principal investigator
Name 29422 0
Address 29422 0
Country 29422 0
Phone 29422 0
Fax 29422 0
Email 29422 0
Contact person for public queries
Name 12669 0
Andrew Hale
Address 12669 0
Medication Services Queensland (MSQ),
RBWH, Block 7, Level 13,
Herston Road,
Herston,
Brisbane,
Queensland,
4006
Country 12669 0
Australia
Phone 12669 0
+61 7 36368782
Fax 12669 0
+61 7 36369098
Email 12669 0
[email protected]
Contact person for scientific queries
Name 3597 0
Ian Coombes
Address 3597 0
MSQ,
RBWH, Block 7, Level 13,
Herston Road,
Herston,
Brisbane,
Queensland,
4006
Country 3597 0
Australia
Phone 3597 0
+61 7 36366251
Fax 3597 0
+61 7 36369098
Email 3597 0
[email protected]

No information has been provided regarding IPD availability


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
No additional documents have been identified.