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Trial registered on ANZCTR


Registration number
ACTRN12618000286246
Ethics application status
Approved
Date submitted
19/02/2018
Date registered
23/02/2018
Date last updated
30/01/2020
Date data sharing statement initially provided
20/02/2019
Date results provided
30/01/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of a community pharmacist-led minor ailments service in collaboration with general practitioners: a cluster randomised controlled trial
Scientific title
Evaluation of a community pharmacist-led minor ailments service in collaboration with general practitioners delivered to adult patients on appropriate use of non-prescription medicines and appropriate medical referral: a cluster randomised controlled trial
Secondary ID [1] 294095 0
Nil known
Universal Trial Number (UTN)
NA
Trial acronym
NA
Linked study record
NA

Health condition
Health condition(s) or problem(s) studied:
Gastroesophageal reflux
 306674 0
Cough
 306675 0
Common cold
306676 0
Primary dysmenorrhoea
 306677 0
Tension headache
306678 0
Migraine
306679 0
Non specific low back pain
 306680 0
Condition category
Condition code
Oral and Gastrointestinal 305774 305774 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Respiratory 305775 305775 0 0
Other respiratory disorders / diseases
Infection 305776 305776 0 0
Other infectious diseases
Reproductive Health and Childbirth 305777 305777 0 0
Menstruation and menopause
Neurological 305778 305778 0 0
Other neurological disorders
Musculoskeletal 305780 305780 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study will use a community pharmacy-based cluster randomised controlled trial (c-RCT) design with an intervention and a control group. The intervention will be trialled by community pharmacists over a 6 month period, but may be extended to 12 months if required if patient numbers are not achieved. As we are aiming to evaluate the impact of an enhanced service compared to the one that is already being delivered in routine practice, we are proposing four innovative features within our study that include:
1. Clinical pathways for minor ailments agreed between general medical practitioner and community pharmacists prior to the beginning of the study.
2. A standardised consultation between the pharmacist and the patient during routine clinical practice using the above clinical pathways.
3. Real time shared clinical information, communication and feedback to the general practitioner.
4. A comprehensive educational training program for pharmacists including strategies to support and improve consumer self-care.

Intervention patients will receive the minor ailments service on presentation to the pharmacy. This will involve a structured one-on-one face-to-face pharmacist-patient consultation with follow up. Pharmacists will follow eight steps in the patient encounter:

–– Service offering, during which the pharmacist explains the features of the service;
–– Obtain written informed consent;
–– Establish the environment (i.e. take the patient to an appropriate or private consulting area);
–– Conduct an appropriate detailed assessment using HealthPathways (to confirm medications; medical conditions and allergies; identify symptoms; identify red flags or other referral criteria);
–– Use the agreed treatment protocols to determine if: (1) the patient would benefit from a non-prescription product; (2) the patient should be referred to a medical practitioner; (3) the patient only requires some verbal and written self-care advice. If a non-prescription product is recommended, the pharmacist will provide verbal and written self-care advice. If referral to another health care professional is indicated, the pharmacist will ensure this is done effectively by providing reasons for referral.
–– Complete the study data collection form as required and patient quality of life assessment;
–– Establish follow up plan (including how and when follow up will be conducted);
–– Notify the patients regular general practitioner using HealthLink (secure messaging system) when a medicine is provided or referral made;

The study will involve a patient follow-up 14 days after the consultation. This follow-up will be conducted by a member of the research team by telephone to assess symptom resolution and health care utilisation for the index ailment.

We will ask intervention pharmacists to participate in:
-- 5-10 minute pharmacist-patient consultation;
-- 2 minutes to document per consultation;
-- 2 minutes to provide electronic feedback to the patient’s usual GP per consultation;
-- 7 hours of minor ailment service training.

We will ask intervention patients to participate in:
-- 5-10 minute pharmacist-patient consultation;
-- 2 minutes to complete the EuroQoL EQ-5D questionnaire;
-- 5 minute follow up telephone call with the research team.

Training of pharmacists
Pharmacists involved in delivering the service (intervention) will attend a two day training seminar at Western Sydney primary health network. The training course comprising of two 3.5-hour sessions will involve a combination of presentation of material, interactive workshops and on-site training delivered by the research team. Training will be supplemented with a pharmacy pack containing information and resources to be utilised throughout the study period.

The entire service will be monitored by Practice Change Facilitators (PCFs), pharmacists who will ensure the quality of the delivery of the interventions and support pharmacists in all processes during the study period.
Intervention code [1] 300374 0
Treatment: Other
Comparator / control treatment
Control patients will receive usual care on presentation to the pharmacy. Pharmacists will follow their usual care practices. I.e. assess and manage patients with minor ailments using their own clinical judgement, processes and resources. This will include a participant eligibility assessment, in which the pharmacist assesses if the patient meets the inclusion/exclusion criteria to participate in the study; study offering, during which the pharmacist explains the features of the study and offers participation in the study; provision of the patient information and informed consent form; usual care, following the usual procedures according to national standards.
Control group
Active

Outcomes
Primary outcome [1] 304849 0
Appropriate use of non-prescription medicines - defined as the use of medication as meeting the entire requirement as approved in product information (PI) by the Therapeutic Goods Administation (TGA) e.g. indications of use, dosage and contraindications.

The information will be collected by the pharmacist during a consultation. An independent researcher will assess the appropriateness of the medicine supplied to the consumer based on the TGA approved indications.
Timepoint [1] 304849 0
Baseline (index consultation pharmacist-patient).
Primary outcome [2] 304850 0
Appropriate medical referral rate - defined as meeting the agreed referral criteria in the respective treatment protocols (HealthPathways).

The information will be collected by the pharmacist during a consultation. An independent researcher will assess the appropriateness of referral based on the agreed referral criteria in HealthPathways.
Timepoint [2] 304850 0
Baseline (index consultation pharmacist-patient).
Secondary outcome [1] 343362 0
Self-reported symptom resolution and median time to resolution of symptoms - defined as the complete absence of symptoms.

The information will be collected by an independent researcher at 14 days telephone follow up by questioning the patient.
Timepoint [1] 343362 0
14 days (telephone call by research team).
Secondary outcome [2] 343363 0
Health services resource utilisation associated with the minor ailment - defined as the use of pharmaceutical services, GP services, hospital services and emergency department.

The information will be collected by an independent researcher at 14 days telephone follow up by questioning the patient.
Timepoint [2] 343363 0
14 days (telephone call by research team).
Secondary outcome [3] 343364 0
Time and resources of service delivery - defined as the time and personnel consumptions for service delivery.

The information will be self-recorded by the pharmacist using a timer.
Timepoint [3] 343364 0
All study periods.
Secondary outcome [4] 343365 0
Health related quality of life - defined as patients general well-being and life satisfaction with the health status.

The information will be collected by the self-administered EuroQoL EQ-5D questionnaire.
Timepoint [4] 343365 0
Baseline (index consultation pharmacist-patient) and repeat at 14 days (telephone call by research team).

Eligibility
Key inclusion criteria
Consumers aged 18 or over will be identified due to one of the qualifying criteria which include:
–– Presenting to the pharmacy in person;
–– Requesting either purchase of a Pharmacy Medicine, the purchase of a Pharmacist Only Medicine, or treatment for symptoms for one of the following ailments (reflux, cough, common cold, headache (tension or migraine), primary dysmenorrhoea and low back pain);
–– Ability to provide written informed consent to participate in the study;
–– Accessible by telephone.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No exclusion criteria will be applied.

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)
An independent researcher will assign the pharmacies (units of randomisation) after they agree to participate in the study, to either intervention group or control group, using a ratio of 1:1..
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer-generated list of random numbers.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Not applicable
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Sample size
The primary joint outcome measures of the trial are appropriate medical referral rate and the appropriate use of a non-prescription product. In this study, sample size calculation is based on an assumed baseline medical referral rate of 10% and 85% of patients using nonprescription products appropriately. Pharmacies are the primary unit of randomization with individual patients nested within pharmacies. The rate of the joint outcomes will be compared between the treatment and control arms in the study. To test for a 10% absolute increase in primary outcomes (referral rate: 10% to 20%, appropriate use of non-prescription products 85% to 95%) with =0.9 power, a of 0.05, equal allocation ratio, and assuming intra-cluster correlation is 0.01 we would need 30 pharmacies (15 in each arm) with 24 participants per pharmacy (allowing for 10% drop-out) for an overall sample of 720 patients.

Data collection methods
Data will be collected from the data collection forms (initial consult with pharmacist and two-week follow up) and relevant demographic and contact information for participating pharmacies will be recorded. Study data will be collected and managed using REDCap electronic data capture tools hosted at The University of Technology Sydney. This allows for the secure transfer of confidential information. The chief investigator will have access to the trial data.

Data analysis plan
Data will be analyzed using Stata 15 for Windows. Baseline pharmacy and patient level information will be summarized by treatment arm. Continuous variables will be summarized with mean, median, standard deviation and inter-quartile range. Categorical variables will be summarized by frequency and proportion. Generalized estimating equations (GEE) will be used to account for within-cluster correlation using an exchangeable correlation structure. A log-binomial model will be used for the analysis to estimate relative rates (RR). If the estimation of RR is not computationally achievable, we will estimate odds ratios (OR) with logistic regression. As a secondary analysis we will include adjustment for key baseline covariates at both the pharmacy level (e.g., pharmacy type) and the patient level (e.g., age, sex). We plan to conduct an exploratory subgroup analysis by treatment classification (respiratory, pain, gastrointestinal). Standard model diagnostics will be conducted to check for model assumptions. All analysis will be intention-to-treat. Multiple imputation by chained equations (MICE) will be applied to account for missing patient outcomes. 30 imputations (including using pharmacy type, age, sex in the MI model) will be performed. A detailed statistical analysis plan will be developed by blinded investigators prior to unblinding and locking the study database.

The economic impact of the model will be evaluated by cost analysis and cost-effectiveness analysis comparing with usual care. The costs and cost-effectiveness of the model may differ according to ailment categories. Therefore, the evaluation will be conducted for the total population as well as for the condition subgroups if sample size allows. The cost analysis will consider costs associated with the delivery of MAS, estimated by applying the unit price estimated within the study to the observed time and personnel consumptions. The capital costs for training, facilitation, information technology and program set-up will be counted. Health service utilization will be based on the cost of pharmaceutical and medical services recorded in the study, with unit prices sourced from MBS and PBS prices. The cost of the nonprescription medication will be determined via averaging the list price of products across pharmacy chains. The potential cost savings associated with the intervention will be determined. Mean estimates of costs will be used and compared between the intervention and control groups using non-parametric methods. Confidence intervals will be generated by bootstrapping the data.

The cost-effectiveness analysis will consider cost per additional appropriate use of nonprescription medicine and cost per additional appropriate referral, calculated with data recorded in the trial. Using preference-based quality of life measurement (EQ-5D-5L) will enable a cost-utility analysis of the intervention compared with usual care. Quality adjusted life year (QALY) scores will be calculated. The primary analysis will only include outcomes recorded in the trial relating to change in health resource utilization and effectiveness (i.e. referral rate). A decision analytic modelling technique will be employed. The model inputs will be informed by data from the trial supplemented with published literature and consultation with key opinion leaders. MAS versus usual care will be evaluated using standard cost-effectiveness analysis. If one strategy is not found to be dominant (i.e. less costly and more effective) in comparison to the other then an ICER will be determined. The ICER will be based on the mean costs and mean QALYs estimated with the decision model.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/03/2018
Actual
1/06/2018
Date of last participant enrolment
Anticipated
31/03/2019
Actual
31/03/2019
Date of last data collection
Anticipated
14/04/2019
Actual
14/04/2019
Sample size
Target
1000
Accrual to date
Final
894
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 21584 0
2148 - Blacktown
Recruitment postcode(s) [2] 21585 0
2145 - Westmead
Recruitment postcode(s) [3] 21587 0
2150 - Parramatta
Recruitment postcode(s) [4] 21588 0
2145 - Wentworthville
Recruitment postcode(s) [5] 21589 0
2768 - Stanhope Gardens
Recruitment postcode(s) [6] 21590 0
2770 - Mount Druitt
Recruitment postcode(s) [7] 21591 0
2147 - Seven Hills

Funding & Sponsors
Funding source category [1] 298729 0
University
Name [1] 298729 0
University of Technology Sydney
Country [1] 298729 0
Australia
Funding source category [2] 302037 0
Commercial sector/Industry
Name [2] 302037 0
ASMI (Australian Self-Medication Industry)
Country [2] 302037 0
Australia
Primary sponsor type
University
Name
University of Technology Sydney
Address
15 Broadway, Ultimo NSW 2007
Country
Australia
Secondary sponsor category [1] 297904 0
None
Name [1] 297904 0
Address [1] 297904 0
Country [1] 297904 0
Other collaborator category [1] 279942 0
Government body
Name [1] 279942 0
Western Sydney primary health network
Address [1] 279942 0
Level 1, 85 Flushcombe Rd, Blacktown NSW 2148
Country [1] 279942 0
Australia
Other collaborator category [2] 279943 0
Commercial sector/Industry
Name [2] 279943 0
Pharmaceutical Society of Australia
Address [2] 279943 0
Level 1, 134 Willoughby Road, Crows Nest NSW 2065
Country [2] 279943 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299673 0
Human Research Ethics Committee
Ethics committee address [1] 299673 0
Ethics committee country [1] 299673 0
Australia
Date submitted for ethics approval [1] 299673 0
20/03/2017
Approval date [1] 299673 0
25/05/2017
Ethics approval number [1] 299673 0
ETH17-1350

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 2434 2434 0 0
/AnzctrAttachments/374547-4_Ethics approval letter.pdf (Ethics approval)

Contacts
Principal investigator
Name 81246 0
Mrs Sarah Dineen-Griffin
Address 81246 0
Graduate School of Health, University of Technology Sydney, City Campus, Broadway, Building 7, Level 4, 67 Thomas Street, Ultimo NSW 2007
Country 81246 0
Australia
Phone 81246 0
+61 412 308 505
Fax 81246 0
Email 81246 0
[email protected]
Contact person for public queries
Name 81247 0
Sarah Dineen-Griffin
Address 81247 0
Graduate School of Health, University of Technology Sydney, City Campus, Broadway, Building 7, Level 4, 67 Thomas Street, Ultimo NSW 2007
Country 81247 0
Australia
Phone 81247 0
+61 2 9514 1448
Fax 81247 0
Email 81247 0
[email protected]
Contact person for scientific queries
Name 81248 0
Sarah Dineen-Griffin
Address 81248 0
Graduate School of Health, University of Technology Sydney, City Campus, Broadway, Building 7, Level 4, 67 Thomas Street, Ultimo NSW 2007
Country 81248 0
Australia
Phone 81248 0
+61 2 9514 1448
Fax 81248 0
Email 81248 0
[email protected]

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
EmbaseCluster randomised controlled trial evaluating the clinical and humanistic impact of a pharmacist-led minor ailment service.2020https://dx.doi.org/10.1136/bmjqs-2019-010608
EmbaseCost utility of a pharmacist-led minor ailment service compared with usual pharmacist care.2020https://dx.doi.org/10.1186/s12962-020-00220-0
N.B. These documents automatically identified may not have been verified by the study sponsor.