Harmful; Use, AlcoholPINONCT04398576
Primary Care Implementation Study to Scale up EIBI and Reduce Alcohol Related Negative Outcomes
A study testing Training and support and Community actions in people with Harmful; Use, Alcohol and Hazardous; Use, Alcohol, run by KU Leuven.
Trial summary
The aim of this implementation study is to compare the effect of tailored training and support (T\&S) for general practioners with T\&S and alcohol community actions and the impact it has on early identification of hazardous and harmful drinking and brief intervention. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Harmful; Use, Alcohol, Hazardous; Use, Alcohol
- What is being tested?
- Training and support and Community actions
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2020to Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- GP or GP trainee
- Dutch language use in practice
- Working in general practice in 3 cities of comparable size or their sub municipalities
Who cannot join
- No possibility of integration of e-form into the EHR-system.
Trial locations and contacts
No sites are listed yet.
Cathy Matheï, master contact
About this study
Official title: Primary Care Implementation Study to Scale up Early Identification and Brief Interventions and Reduce Alcohol Related Negative Outcomes at Community Level (PINO): Study Protocol for a Quasi-experimental 3-arm Study
The aim of this implementation study is to compare the effect of tailored training and support (T\&S) for general practioners with T\&S and alcohol community actions and the impact it has on early identification of hazardous and harmful drinking and brief intervention.
Read the detailed description
A quasi-experimental three-arm implementation study will be undertaken in Flanders (Belgium) to assess the effects of tailored training and support to general practitioners (GPs) alone or in an area context of alcohol community actions and compared to 'support as usual' on GP's performance in terms of early identification of hazardous and harmful drinking and brief intervention.
The study will last 18 months and will take place in three cities of comparable size. In each area at least 28 GPs will be recruited.
The primary outcome will be the proportion of consulting adult patients screened for hazardous and harmful alcohol use at the end-point of an 18-month implementation period. The secondary outcomes will be the screening rate as assessed at 3, 6, 9, 12 and 15 months and the proportion of patients screening positive for hazardous and harmful alcohol use that receive a brief intervention at 3,6,9, 12, 15 and 18 months. Furthermore, the relation between GP's views and needs and practices' contexts, and EIBI performance will be explored.
Data regarding screening and brief intervention activities will be collected from the electronic health records (EHR).
- Conditions
- Harmful; Use, Alcohol, Hazardous; Use, Alcohol
- Being tested
- Training and support, Community actions
- Keywords
- Alcohol, Screening, Brief Intervention, Implementation, Training and Support, Primary Healthcare, Scaling up, Community actions, hazardous alcohol use heavy drinking, harmful use of alcohol, heavy drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Training and supportBehavioural
GP's receive the tools to make early identification of harmful and hazardous alcohol use possible. They are given guidelines to apply a brief intervention. At the start of the study, the T\&S-group receives two face-to-face educational trainings of two hours each. Another two face-to-face booster sessions will follow at 6 and at 12 months.
Community actionsBehavioural
There will be embedded community-based actions within a local strategy.
| Study group | Role | What they receive |
|---|---|---|
| Support as usual | No intervention | There will be no interventions, only support as usual. All GPs receive an information package by post or via e-mail containing: * Belgian guidelines on the management of hazardous and harmful alcohol use * A summary card about EIBI for hazardous and harmful alcohol consumption. * Internet links to documentation of the medical association and the Flemish centre of expertise on alcohol and drugs(31). An EHR-update allows the use of an extra e-form permitting standardised introduction of screening results from the Alcohol Use Disorders Identification Test (-Consumption) (AUDIT(-C)), alcohol-related diagnoses and actions including provision of oral brief advice/intervention, referral to a digital-based system for advice and/or referral to another health care provider. |
| Training and support | Active comparator | All GPs receive an information package by post or via e-mail containing:
* Belgian guidelines on the management of hazardous and harmful alcohol use
* A summary card about EIBI for hazardous and harmful alcohol consumption.
* Internet links to documentation of the medical association and the Flemish centre of expertise on alcohol and drugs(31).
An EHR-update allows the use of an extra e-form permitting standardised introduction of screening results from the Alcohol Use Disorders Identification Test (-Consumption) (AUDIT(-C)), alcohol-related diagnoses and actions including provision of oral brief advice/intervention, referral to a digital-based system for advice and/or referral to another health care provider.
There shall be tailored training and support for the general practioners. At the start of the study, this group receives two face-to-face educational trainings of two hours each. Another two face-to-face booster sessions will follow at 6 and at 12 months. Receives: Behavioral: Training and support |
| Training and support and community actions | Active comparator | In this group, GPs receive the same training and support as in the second arm (training and support). There will also be embedded community-based actions within a local strategy. Receives: Behavioral: Training and support; Behavioral: Community actions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early Identification Rate (EIR)
The Primary outcome or the Early Identification Rate (EIR) is the proportion of adult consulting patients (18 years and over) that is screened for alcohol consumption during a period of 18 months per area.
Measured: 18 months
Secondary outcomes (2)
EIR every 3 months
The Early Identification Rate (EIR) assessed at 3, 6, 9, 12 and 15 months per area.
Measured: at 3, 6, 9, 12 and 15 months
BIR
The Brief Intervention rate (BIR) is the proportion of patients screening positive for hazardous or harmful alcohol use that received oral brief advice/intervention and/or were referred to digital-based system for advice, and/or were referred to another provider assessed at 3, 6, 9, 12, 15 and 18 months per area.
Measured: at 3, 6, 9, 12, 15 and 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2020
- Study start1 Jul 2020 (estimated)
- Primary completionOct 2021 (estimated)
- Study completionFeb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Harmful; Use, AlcoholStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cathy Matheï, KU Leuven
- Investigators
- Cathy Matheï, master, Principal investigator, professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04398576
- Sponsor's protocol ID
- s63342
- Acronym
- PINO
- Status last verified
- May 2020
- First submitted
- 13 May 2020
- Last updated
- 21 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pussig B, Pas L, Li A, Vermandere M, Aertgeerts B, Mathei C. Primary care implementation study to scale up early identification and brief intervention and reduce alcohol-related negative outcomes at the community level (PINO): study protocol for a quasi-experimental 3-arm study. BMC Fam Pract. 2021 Jul 1;22(1):144. doi: 10.1186/s12875-021-01479-9.
PubMed 34210261
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Primary Care Implementation Study to Scale up Early Identification and Brief Interventions and Reduce Alcohol Related Negative Outcomes at Community Level (PINO): Study Protocol for a Quasi-experimental 3-arm Study
- ClinicalTrials.gov ID
- NCT04398576
- Acronym / sponsor ID
- PINO / s63342
- Conditions
- Harmful; Use, Alcohol, Hazardous; Use, Alcohol
- Keywords
- Alcohol, Screening, Brief Intervention, Implementation, Training and Support, Primary Healthcare, Scaling up, Community actions
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Study start
- 1 Jul 2020 (estimated)
- Primary completion
- Oct 2021 (estimated)
- Study completion
- Feb 2022 (estimated)
- First posted
- 21 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this implementation study is to compare the effect of tailored training and support (T\&S) for general practioners with T\&S and alcohol community actions and the impact it has on early identification of hazardous and harmful drinking and brief intervention.
Detailed description
A quasi-experimental three-arm implementation study will be undertaken in Flanders (Belgium) to assess the effects of tailored training and support to general practitioners (GPs) alone or in an area context of alcohol community actions and compared to 'support as usual' on GP's performance in terms of early identification of hazardous and harmful drinking and brief intervention.
The study will last 18 months and will take place in three cities of comparable size. In each area at least 28 GPs will be recruited.
The primary outcome will be the proportion of consulting adult patients screened for hazardous and harmful alcohol use at the end-point of an 18-month implementation period. The secondary outcomes will be the screening rate as assessed at 3, 6, 9, 12 and 15 months and the proportion of patients screening positive for hazardous and harmful alcohol use that receive a brief intervention at 3,6,9, 12, 15 and 18 months. Furthermore, the relation between GP's views and needs and practices' contexts, and EIBI performance will be explored.
Data regarding screening and brief intervention activities will be collected from the electronic health records (EHR).
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Support as usual | No intervention | –There will be no interventions, only support as usual. All GPs receive an information package by post or via e-mail containing: * Belgian guidelines on the management of hazardous and harmful alcohol use * A summary card about EIBI for hazardous and harmful alcohol consumption. * Internet links to documentation of the medical association and the Flemish centre of expertise on alcohol and drugs(31). An EHR-update allows the use of an extra e-form permitting standardised introduction of screening results from the Alcohol Use Disorders Identification Test (-Consumption) (AUDIT(-C)), alcohol-related diagnoses and actions including provision of oral brief advice/intervention, referral to a digital-based system for advice and/or referral to another health care provider. |
| Training and support | Active comparator | Behavioral: Training and supportAll GPs receive an information package by post or via e-mail containing: * Belgian guidelines on the management of hazardous and harmful alcohol use * A summary card about EIBI for hazardous and harmful alcohol consumption. * Internet links to documentation of the medical association and the Flemish centre of expertise on alcohol and drugs(31). An EHR-update allows the use of an extra e-form permitting standardised introduction of screening results from the Alcohol Use Disorders Identification Test (-Consumption) (AUDIT(-C)), alcohol-related diagnoses and actions including provision of oral brief advice/intervention, referral to a digital-based system for advice and/or referral to another health care provider. There shall be tailored training and support for the general practioners. At the start of the study, this group receives two face-to-face educational trainings of two hours each. Another two face-to-face booster sessions will follow at 6 and at 12 months. |
| Training and support and community actions | Active comparator | Behavioral: Training and support, Behavioral: Community actionsIn this group, GPs receive the same training and support as in the second arm (training and support). There will also be embedded community-based actions within a local strategy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- GP or GP trainee
- Dutch language use in practice
- Working in general practice in 3 cities of comparable size or their sub municipalities
Key exclusion criteria (1 listed)
- No possibility of integration of e-form into the EHR-system.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Training and supportGP's receive the tools to make early identification of harmful and hazardous alcohol use possible. They are given guidelines to apply a brief intervention. At the start of the study, the T\&S-group receives two face-to-face educational trainings of two hours each. Another two face-to-face booster sessions will follow at 6 and at 12 months. | Behavioural | Training and support, Training and support and community actions |
| Community actionsThere will be embedded community-based actions within a local strategy. | Behavioural | Training and support and community actions |
Primary outcome
Early Identification Rate (EIR)
Time frame: 18 months
The Primary outcome or the Early Identification Rate (EIR) is the proportion of adult consulting patients (18 years and over) that is screened for alcohol consumption during a period of 18 months per area.
2 secondary outcomes
EIR every 3 months
Time frame: at 3, 6, 9, 12 and 15 months
BIR
Time frame: at 3, 6, 9, 12, 15 and 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2020.
- Derived from this study: PubMed 34210261Pussig B, Pas L, Li A, Vermandere M, Aertgeerts B, Mathei C. Primary care implementation study to scale up early identification and brief intervention and reduce alcohol-related negative outcomes at the community level (PINO): study protocol for a quasi-experimental 3-arm study. BMC Fam Pract. 2021 Jul 1;22(1):144. doi: 10.1186/s12875-021-01479-9.
- Individual participant dataSharing planned: No
Related trials for Harmful; Use, Alcohol
Recruiting
Elastography-based Brief Alcohol Intervention in Hospitalized Individuals
Alcoholic Liver Disease (ALD), Alcohol Use Disorder
Active, not recruiting
Improving Help-seeking Propensity Through a Micro-intervention Targeting Common Concerns Among Individuals With Alcohol Problems: A Randomized Controlled Experiment
Alcohol Abuse, Harmful Alcohol Use
Recruiting
Sleep as a Mechanism of Change in Alcohol Use
Insomnia, Alcohol; Harmful Use
Not yet recruiting
Integrated Digital Health Approach to Reduce Hazardous Alcohol Use and Chronic Pain Among Rural Populations
Chronic Pain, Unhealthy Alcohol Use
Not yet recruiting
Telephone-Based Acceptance and Commitment Therapy for Young Adult Hazardous Drinkers
Hazardous Drinking, Harmful Alcohol Use
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cathy Matheï, master contact
Cathy Matheï, master principal investigator
professor
Questions about this trial
What is this clinical trial studying?
A study testing Training and support and Community actions in people with Harmful; Use, Alcohol and Hazardous; Use, Alcohol, run by KU Leuven.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 May 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ann Li, master (+32 16 37 21 82, ann.li@kuleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Early Identification Rate (EIR) (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04398576, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2020.