Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12622000959774
Ethics application status
Approved
Date submitted
1/07/2022
Date registered
7/07/2022
Date last updated
7/07/2022
Date data sharing statement initially provided
7/07/2022
Date results provided
7/07/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
REACH Project: Reducing Alcohol-related harm in General Practice
Scientific title
Acceptability and efficacy of a novel approach to alcohol brief interventions in primary care: The REACH Project
Secondary ID [1] 307436 0
Nil
Universal Trial Number (UTN)
Trial acronym
REACH Project
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Risky or excessive alcohol use 326802 0
Condition category
Condition code
Public Health 324020 324020 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Context: Alcohol brief interventions involve assessing a person’s alcohol use and offering individualised advice to reduce health risks. These are effective in reducing the average amount of alcohol people consume in a week. Despite their effectiveness, clinicians may find it difficult to offer brief interventions in daily practice.

Aim: To better support clinicians to provide brief interventions for alcohol in general practice

1. Physical or informational materials: an innovative resource pack with materials including patient priming materials, clinician resources and consultation resources. Resources were designed specifically for this study. Content was adapted from evidence based resources (1-4)*
- Waiting room poster that shows the health harms of alcohol and shows the names of GPs at
the practice who are particularly interested or skilled in helping their patients manage their
alcohol use.
- Waiting room survey that includes questions about smoking, nutrition, alcohol and physical
activity that patients can fill in while they wait for their doctor or nurse. Patients and clinicians
can use the completed form as a way of starting a discussion about alcohol.
- “Talk to me about alcohol” signs to be displayed in doctors’ and nurses’ offices encouraging
patients to bring up their alcohol use during their consultation.
- Brief interventions flowchart and standard drinks guide shows the steps to delivering an
alcohol brief intervention, including, asking about alcohol intake, advising patients about the
risks from their alcohol use, assessing readiness to change and motivational interviewing tips,
and referral options. The standard drinks guide can be used to quantify alcohol intake.
- Alcohol intake and health risks charts show how the risk for cancer (breast, prostate, colorectal) and stroke increase with increasing alcohol intake. Clinicians were encouraged to keep these charts alongside other clinical resources in the consultation room and discuss them with patients when delivering the brief intervention to their patients.
- Podcast featuring clinicians speaking about brief interventions for alcohol in general practice and how they encourage behaviour change to reduce alcohol related harms among patients. Clinicians were encouraged to listen to the 1 hour podcast and adapt their practice based on the insights offered.
- Patient brochures present the national recommendations on alcohol intake (NHMRC), the
health harms of alcohol use, the benefits of reducing alcohol intake including practical
strategies for managing cravings and triggers, a standard drinks guide, and where to go for
more help. Patient brochures are available in multiple languages.

2. Intervention procedures
- Practices will identify a champion to promote the intervention to their colleagues. After the resources are introduced by practice engagement staff, practice champions will use existing practice communication channels e.g. weekly practice meetings or emails to raise awareness of practice staff about the resources, promote the use of resources during the trial period, liaise with primary care commissioning organisation (Primary Health Network) staff to troubleshoot any issues with resource use and share practice performance information with staff.
- Practice engagement staff from a primary care commissioning organisation (Primary Health Network) will support implementation at the practice with quarterly, 30 minute to 1 hour visits or telephone calls to provide ongoing feedback on practice performance and to promote use of the clinical resources. The practice champion will receive a written performance report and will be asked about whether and how resources are used with the intention of encouraging routine use. Practice champions will be offered additional information on the evidence behind the resources or additional clinical or referral information relating to alcohol harm reduction as needed. The practice champion will be encouraged to distribute the information they receive to other staff at the practice.

Who
- Practice visits will be delivered by practice engagement staff with knowledge of general practice operations and expertise in primary care relationship management/data use and interpretation.
- General practitioners or practice nurses will deliver alcohol brief interventions to patients.

Mode of delivery
- Practice visits will be delivered in group settings via telephone or videoconferencing due to pandemic restrictions during the intervention period.
- Alcohol brief interventions will be delivered face-to-face or via telehealth to individual patients.

Frequency
- Practice visits will occur quarterly over the 1 year intervention period, with a total of four contacts.
- Alcohol brief interventions can be delivered in a single consultation (10 minutes per session) or over 2 or more consultations as deemed appropriate by the clinician and patient. All patients who attend the practice during the trial period and meet the eligibility criteria will be offered the intervention.

Location
- All activities will be conducted with general practice settings.

Personalisation
- Participating practices will receive additional support and information from the primary care commissioning organisation staff as needed.
- Patients will receive support for risky alcohol use as clinically indicated.

The RE-AIM framework will be used to assess implementation. Measures include
Reach: the change in proportion of patient records with information on alcohol status (drinks alcohol; does not drink alcohol) as a proxy marker for where a brief intervention (BI) is likely to have occurred.
Acceptability: to patients, clinicians, practice staff, and PHN staff.
Adoption: within each practice and within the PHN processes.
Fidelity of intervention implementation via project timelines completed by the PHN, research team, and member-checked during provider interviews.
Sustainability as perceived by practice staff, clinicians, and PHN staff.

Data on acceptability, adoption, fidelity and sustainability will be collected by the research team using semi-structured interviews.

References
1. How much is too much? In: National Health Service U, editor. Online2007.
2. Saunders JB, Aasland OG, Amundsen A, Grant M. Alcohol consumption and related
problems among primary health care patients: WHO collaborative project on early detection
of persons with harmful alcohol consumption--I. Addiction. 1993;88(3):349-62.
3. Saunders JB, Aasland OG, Babor TF, de la Fuente JR, Grant M. Development of the
Alcohol Use Disorders Identification Test (AUDIT): WHO Collaborative Project on Early
Detection of Persons with Harmful Alcohol Consumption--II. Addiction. 1993;88(6):791-
804.
4. Canadian Centre on Substance Use and Addiction. Knowing your limits with alcohol
2019 [Available from: https://www.ccsa.ca/sites/default/files/2019-08/CCSA-Knowing-
Your-Limits-with-Alcohol-Guide-2019-en_0.pdf.
Intervention code [1] 323875 0
Early detection / Screening
Comparator / control treatment
All recruited practices will receive the intervention (see above).
De-identified aggregated data from all practices relating to patients' alcohol status (i.e. drinker, non-drinker, not recorded or not applicable as the patient is under 14 years of age [minimum age for screening]) in the primary care commissioning organisation's catchment will be used as a comparator/control for intervention practices. The observation period was from Jan 2019 to October 2021
Control group
Active

Outcomes
Primary outcome [1] 331810 0
The primary outcome is the change in the proportion of adult patients (aged >15 years) with completed alcohol histories in their electronic medical record
Timepoint [1] 331810 0
Baseline, 10 months post-intervention commencement
Secondary outcome [1] 411241 0
Implementation outcomes, informed by RE-AIM, include:

Acceptability to patients, clinicians, practice staff, and PHN staff.
Adoption within each practice and within the PHN processes.
Fidelity of intervention implementation via project timelines completed by the PHN, research team, and member-checked during provider interviews.
Sustainability as perceived by practice staff, clinicians, and PHN staff.

All data was collected using in-depth, individual, semi-structured interviews during intervention or post intervention (see timing below)
Timepoint [1] 411241 0
Baseline, During intervention (3-months, 6-months), 10 months post-intervention commencement

Eligibility
Key inclusion criteria
General practices
- Operating in the Melbourne metropolitan regions in lower socio-economic status areas
- Using one of two patient information management systems that allow for collection/extraction of alcohol status and histories (Medical Director, Best Practice)
- At least one GP consents to participate in study

Patients
- At least one visit to practice within the last three months
- Over 18 years
- Able to give informed consent i.e. proficient in English and not of reduced capacity.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
General practices
- Undergoing or planned major organisational change during intervention period

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Not applicable
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Not applicable
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Quantitative data will be analysed descriptively, with means and standard deviations or medians and ranges reported for continuous variables, and proportions for categorical variables. Correlations will be calculated using the Spearman's Rho method owing to the anticipated non-normal distribution of scores. Repeated measures data will be analysed using a non-parametric statistics such as the McNemar and Wilcoxon signed-rank test. Multiple regressions will be conducted to assess associations between the intervention measures.
Interrupted time series An interrupted time series analysis will be performed using data from the enrolled clinics, as well as the 850 clinics within the same catchment to determine how much alcohol screening has changed in the intervention clinics and across whole PHN over the study period.

Qualitative analysis: Audio files of interviews will be de-identified and professionally transcribed. Analyses will be conducted using NVivo (version 10 or higher).
Although the interview guides will be based on CFIR, inductive thematic coding will be used to ensure the findings are grounded in the data and not a pre-existing framework. Summarised findings and early interpretations will be discussed with the research team in regular small team meetings. The authors will also meet on a minimum of two occasions with the entire investigator team to finalise the themes from the data.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
18/08/2020
Date of last participant enrolment
Anticipated
Actual
20/11/2020
Date of last data collection
Anticipated
Actual
31/08/2021
Sample size
Target
6
Accrual to date
Final
5
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 37887 0
3169 - Clayton South
Recruitment postcode(s) [2] 37888 0
3029 - Tarneit
Recruitment postcode(s) [3] 37889 0
3020 - Sunshine
Recruitment postcode(s) [4] 37890 0
3429 - Sunbury
Recruitment postcode(s) [5] 37891 0
3438 - New Gisborne
Recruitment postcode(s) [6] 37892 0
3015 - Newport
Recruitment postcode(s) [7] 37893 0
3011 - Footscray

Funding & Sponsors
Funding source category [1] 311707 0
Charities/Societies/Foundations
Name [1] 311707 0
Victorian Health Promotion Foundation (VicHealth)
Country [1] 311707 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Monash University, Clayton, Victoria 3800. Australia
Country
Australia
Secondary sponsor category [1] 313164 0
None
Name [1] 313164 0
Address [1] 313164 0
Country [1] 313164 0
Other collaborator category [1] 282345 0
University
Name [1] 282345 0
Griffith University
Address [1] 282345 0
Griffith University
170 Kessels Road
Nathan Qld 4111
Australia
Country [1] 282345 0
Australia
Other collaborator category [2] 282346 0
Hospital
Name [2] 282346 0
Monash Health
Address [2] 282346 0
Monash Health
246 Clayton Rd, Clayton VIC 3168
Country [2] 282346 0
Australia
Other collaborator category [3] 282347 0
Charities/Societies/Foundations
Name [3] 282347 0
Health Issues Centre
Address [3] 282347 0
Suite 4758, 805/220 Collins St, Melbourne VIC 3000
Country [3] 282347 0
Australia
Other collaborator category [4] 282348 0
Charities/Societies/Foundations
Name [4] 282348 0
enliven
Address [4] 282348 0
186 Foster St E, Dandenong VIC 3175
Country [4] 282348 0
Australia
Other collaborator category [5] 282349 0
Government body
Name [5] 282349 0
North Western Melbourne Primary Health Network
Address [5] 282349 0
1/369 Royal Parade, Parkville VIC 3052
Country [5] 282349 0
Australia
Other collaborator category [6] 282350 0
University
Name [6] 282350 0
University of New South Wales
Address [6] 282350 0
Sydney NSW 2052
Country [6] 282350 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311159 0
Monash University Human Research Ethics Committee
Ethics committee address [1] 311159 0
Ethics committee country [1] 311159 0
Australia
Date submitted for ethics approval [1] 311159 0
02/12/2019
Approval date [1] 311159 0
02/01/2020
Ethics approval number [1] 311159 0
2021-22865-63945

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

Contacts
Principal investigator
Name 120154 0
Dr Liz Sturgiss
Address 120154 0
School of Primary and Allied Health Care
Monash University Peninsula Campus,
Frankston, Victoria 3199
Country 120154 0
Australia
Phone 120154 0
+61 412 233 119
Fax 120154 0
Email 120154 0
[email protected]
Contact person for public queries
Name 120155 0
Nilakshi Gunatillaka
Address 120155 0
School of Primary and Allied Health Care
Monash University Peninsula Campus,
Frankston, Victoria 3199
Country 120155 0
Australia
Phone 120155 0
+61 430014426
Fax 120155 0
Email 120155 0
[email protected]
Contact person for scientific queries
Name 120156 0
Liz Sturgiss
Address 120156 0
School of Primary and Allied Health Care
Monash University Peninsula Campus,
Frankston, Victoria 3199
Country 120156 0
Australia
Phone 120156 0
+61 412 233 119
Fax 120156 0
Email 120156 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
Ethics approval not obtained.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
16473Study protocolSturgiss E, Gunatillaka N, Ball L, et al. Embedding brief interventions for alcohol in general practice: a study protocol for the REACH Project feasibility trial. BJGP Open. 2021;5(4):BJGPO.2021.0037. Published 2021 Aug 24. doi:10.3399/BJGPO.2021.0037https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8450877/ 



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.