NCT02968186

Brief Summary

The objective of this study is to investigate the efficacy of an implementation program specifically designed to increase alcohol screening and brief intervention rates in primary health care.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
222

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2016

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

November 16, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 18, 2016

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
Last Updated

January 13, 2020

Status Verified

January 1, 2020

Enrollment Period

1.3 years

First QC Date

November 16, 2016

Last Update Submit

January 9, 2020

Conditions

Alcohol-Related Disorders

Keywords

Mass ScreeningCounselingPrimary Health Care

Outcome Measures

Primary Outcomes (1)

  • Alcohol screening rate

    Percentage of eligible patients visiting the primary health care centre for an appointment with a general practitioner or nurse who were screened for alcohol use with the Alcohol Use Disorders Identification Test

    12 months

Secondary Outcomes (5)

  • Improvement of general practitioners attitudes toward at-risk drinkers

    12 months

  • Improvement in knowledge related to alcohol screening and brief intervention

    12 months

  • Improvement in barriers for implementing alcohol screening and brief intervention

    12 months

  • Utility of materials used in the trial

    Through study completion, an average of 12 months

  • Brief intervention rate

    12 months

Study Arms (2)

Implementation program

EXPERIMENTAL

Health professionals will receive a training and support implementation program

Behavioral: Implementation program

Waiting list

NO INTERVENTION

Health professionals will be assigned to a waiting list to receive the implementation program

Interventions

Implementation programBEHAVIORAL

Health professionals in the intervention arm will receive up to four training sessions in the first three months of the implementation period. Practice support will be continuously available throughout the project. Posters specifically designed for this project will be added to the primary health care units aiming to facilitate eliciting alcohol issues during the consultations, and to help professionals remembering to conduct alcohol screening and brief intervention. Leaflets to be handed-in to patients were also specifically produced for this project, aiming to aid professionals in advising at-risk drinkers to cut down. The research team will schedule with each primary health care unit regular visits for feedback on the progress of the program.

Implementation program

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Primary health care units of the Dão Lafões Grouping of Primary Health Care Centres (family physicians/general practitioners, family medicine residents, practice nurses and receptionists)

You may not qualify if:

  • Primary health care units with four or less general practitioners
  • Primary health care units that have a specific alcohol program already implemented

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dão Lafões Grouping of Primary Health Care Centres

Viseu, Dão Lafões, 3514-511, Portugal

Location

Related Publications (1)

  • Rosario F, Vasiljevic M, Pas L, Fitzgerald N, Ribeiro C. Implementing alcohol screening and brief interventions in primary health care: study protocol for a pilot cluster randomized controlled trial. Fam Pract. 2019 Mar 20;36(2):199-205. doi: 10.1093/fampra/cmy062.

    PMID: 29939239BACKGROUND

MeSH Terms

Conditions

Alcohol-Related Disorders

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Frederico M Rosário, MD

    Dão Lafões Grouping of Primary Health Care Centres

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

November 16, 2016

First Posted

November 18, 2016

Study Start

November 1, 2016

Primary Completion

March 1, 2018

Study Completion

July 1, 2018

Last Updated

January 13, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

PT(1)