Academic Detailing About Asthma (BRIEF-A)

June 29, 2022 updated by: Jón Þór Trærup Andersen, University Hospital Bispebjerg and Frederiksberg

Boosting General Practice pRescription by Individual Educational Fast Academic Detailing Visits About Asthma

General practices in the Capital Region of Denmark are offered a short educational visit and are randomized to either asthma (intervention) or another topic (control).

The change in prescription pattern from before to after the visit is compared between the intervention and control group.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

General practices in the Capital Region of Denmark are offered a short educational visit. They are randomized by address to be offered a visit about either asthma (intervention) or another topic (control).

The prescription pattern of each general practice (as seen by their regional registration number [ydernummer]) who receive a visit is investigated.

The change in prescription pattern from before to after the visit is compared between the intervention and control group.

Study Type

Interventional

Enrollment (Anticipated)

360

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Denmark
    • Capital Region Of Denmark
      • Copenhagen, Capital Region Of Denmark, Denmark, 2400
        • Recruiting
        • University Hospital Bispebjerg and Frederiksberg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • General practices in the capital region of denmark, who owns a regional registration number [ydernummer]
  • Want a visit
  • Have time for a visit within the study period

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: asthma education
The general practices in this arm will receive the education visits about asthma.
Behavioral: asthma education
A 15 minutes (preferable) one-on-one educational visit about asthma treatment. The main points being: Every person with asthma should be treated with inhaled corticosteroids (ICS). Most patients with asthma should be treated with Bufomix Easyhaler either as needed and/or regularly. Patients should not use short-acting bega2-agonist (SABA) unless they use a medium-ICS-dosis.
Placebo Comparator: Other education
The general practices in this arm will receive an educational visit on another topic (PPI).
Behavioral: Other education
A 15 minutes (preferable) one-on-one educational visit about another topic (NOT asthma).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference in change of prescription of inhaled corticosteroids and long-acting beta2-agonist (ICS+LABA) before and after educational visit in a six months period
Time Frame: 6-0 months before and 6-12 months after educational visit
Difference in change of number of adult patients with prescriptions on ICS+LABA between asthma-group and placebo-group.
6-0 months before and 6-12 months after educational visit
Difference in change of prescription of ICS and SABA (as monotherapy) before and after educational visit in a six months period
Time Frame: 6-0 months before and 6-12 months after educational visit
Difference in change of number of adult patients with prescriptions on ICS and SABA as monotherapy to adults between asthma-group and placebo-group.
6-0 months before and 6-12 months after educational visit

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference in change of prescription of ICS+LABA before and after educational visit in one year
Time Frame: one year before and one year after educational visit
Difference in change of number of adult patients with prescriptions on ICS+LABA between asthma-group and placebo-group
one year before and one year after educational visit
Difference in change of prescription of ICS+LABA before and after educational visit in one year as interrupted time series analysis
Time Frame: one year before and one year after educational visit
Difference in change of number of adult patients with prescriptions on ICS+LABA between asthma-group and placebo-group as interrupted time series analysis
one year before and one year after educational visit
Difference in change of prescription of ICS+LABA before and after educational visit in one year for each month
Time Frame: one year before and one year after educational visit
Difference in change of number of adult patients with prescriptions on ICS+LABA between asthma-group and placebo-group analyzed by each month in relation to the visit
one year before and one year after educational visit
Difference in change of prescription of ICS and SABA (as monotherapy) before and after educational visit one year
Time Frame: one year before and one year after educational visit
Difference in change of number of adult patients with prescriptions on ICS or on SABA as monotherapy to adults between asthma-group and placebo-group.
one year before and one year after educational visit
Difference in change of prescription of ICS and SABA (as monotherapy) before and after educational visit one year as interrupted time series analysis
Time Frame: one year before and one year after educational visit
Difference in change of number of adult patients with prescriptions on ICS or on SABA as monotherapy to adults between asthma-group and placebo-group as interrupted time series analysis
one year before and one year after educational visit
Difference in change of prescription of ICS and SABA (as monotherapy) before and after educational visit one year for each month
Time Frame: one year before and one year after educational visit
Difference in change of number of adult patients with prescriptions on ICS and on SABA as monotherapy to adults between asthma-group and placebo-group analyzed by each month in relation to the visit
one year before and one year after educational visit
Difference in change of prescription of the Easyhaler Device before and after educational visit in a six months period
Time Frame: 6-0 months before and 6-12 months after educational visit
Difference in change of number of adult patients with prescription on the Easyhaler Device between asthma-group and placebo-group
6-0 months before and 6-12 months after educational visit
Difference in change of prescription of the Easyhaler Device before and after educational visit in one year
Time Frame: one year before and one year after educational visit
Difference in change of number of adult patients with prescription on the Easyhaler Device between asthma-group and placebo-group
one year before and one year after educational visit
Difference in change of prescription of the Easyhaler Device before and after educational visit as interrupted time series analysis
Time Frame: one year before and one year after educational visit
Difference in change of number of adult patients with prescription on the Easyhaler Device between asthma-group and placebo-group as interrupted time series analysis
one year before and one year after educational visit
Difference in change of prescription of the Easyhaler Device before and after educational visit for each month
Time Frame: one year before and one year after educational visit
Difference in change of number of adult patients with prescription on the Easyhaler Device between asthma-group and placebo-group analyzed by each month in relation to the visit
one year before and one year after educational visit
Difference in change of prescription of long-acting muscarinic antagonist (LAMA) before and after educational visit in a six months period
Time Frame: 6-0 months before and 6-12 months after educational visit
Difference in change of number of adult patients with prescription on LAMA between asthma-group and placebo-group
6-0 months before and 6-12 months after educational visit
Difference in change of prescription of LAMA before and after educational visit in one year
Time Frame: one year before and one year after educational visit
Difference in change of number of adult patients with prescription on LAMA between asthma-group and placebo-group
one year before and one year after educational visit
Difference in change of prescription of LAMA before and after educational visit as interrupted time series analysis
Time Frame: one year before and one year after educational visit
Difference in change of number of adult patients with prescription on LAMA between asthma-group and placebo-group
one year before and one year after educational visit
Difference in change of prescription of LAMA before and after educational visit for each month
Time Frame: one year before and one year after educational visit
Difference in change of number of adult patients with prescription on LAMA between asthma-group and placebo-group analyzed by each month in relation to the visit
one year before and one year after educational visit
Difference in change of cost of each medication group before and after educational visit in a six months period
Time Frame: 6-0 months before and 6-12 months after educational visit
Difference in change of cost (pharmacy retail price) of SABA, ICS, ICS+LABA, LAMA and ICS+LAMA+LABA to adults between asthma-group and placebo-group
6-0 months before and 6-12 months after educational visit
Difference in change of cost of each medication group before and after educational visit in one year
Time Frame: one year before and one year after educational visit
Difference in change of cost (pharmacy retail price) of SABA, ICS, ICS+LABA, LAMA and ICS+LAMA+LABA to adults between asthma-group and placebo-group
one year before and one year after educational visit
Difference in change of cost of each medication group before and after educational visit as interrupted time series analysis
Time Frame: one year before and one year after educational visit
Difference in change of cost (pharmacy retail price) of SABA, ICS, ICS+LABA, LAMA and ICS+LAMA+LABA to adults between asthma-group and placebo-group
one year before and one year after educational visit
Difference in change of cost of each medication group before and after educational visit for each month
Time Frame: one year before and one year after educational visit
Difference in change of cost (pharmacy retail price) of SABA, ICS, ICS+LABA, LAMA and ICS+LAMA+LABA to adults between asthma-group and placebo-group analyzed by each month in relation to the visit
one year before and one year after educational visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Bispebjerg and Frederiksberg

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 6, 2021

Primary Completion (Anticipated)

November 1, 2023

Study Completion (Anticipated)

November 1, 2023

Study Registration Dates

First Submitted

October 6, 2021

First Submitted That Met QC Criteria

June 29, 2022

First Posted (Actual)

July 5, 2022

Study Record Updates

Last Update Posted (Actual)

July 5, 2022

Last Update Submitted That Met QC Criteria

June 29, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • P-2021-709

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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