BRIEF-A: Academic Detailing About Asthma

• Sponsor: University Hospital Bispebjerg and Frederiksberg (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05442307
• Collaborator: (none)
• Enrollment: 360
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 24.8
• Patients Per Site Per Month: 14.5

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Prescription Pattern	Behavioral: asthma education; Behavioral: Other education	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 360 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: randomized placebo controlled studyrandomized placebo controlled study
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: Boosting General Practice pRescription by Individual Educational Fast Academic Detailing Visits About Asthma
• Actual Study Start Date: Oct 6, 2021
• Anticipated Primary Completion Date: Nov 1, 2023
• Anticipated Study Completion Date: Nov 1, 2023

Arms and Interventions

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).

Outcome Measures

Primary Outcome Measures

1. 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 [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.

2. Difference in change of prescription of ICS and SABA (as monotherapy) before and after educational visit in a six months period [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.

Secondary Outcome Measures

1. Difference in change of prescription of ICS+LABA before and after educational visit in one year [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

2. Difference in change of prescription of ICS+LABA before and after educational visit in one year as interrupted time series analysis [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

3. Difference in change of prescription of ICS+LABA before and after educational visit in one year for each month [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

4. Difference in change of prescription of ICS and SABA (as monotherapy) before and after educational visit one year [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.

5. Difference in change of prescription of ICS and SABA (as monotherapy) before and after educational visit one year as interrupted time series analysis [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

6. Difference in change of prescription of ICS and SABA (as monotherapy) before and after educational visit one year for each month [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

7. Difference in change of prescription of the Easyhaler Device before and after educational visit in a six months period [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

8. Difference in change of prescription of the Easyhaler Device before and after educational visit in one year [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

9. Difference in change of prescription of the Easyhaler Device before and after educational visit as interrupted time series analysis [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

10. Difference in change of prescription of the Easyhaler Device before and after educational visit for each month [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

11. Difference in change of prescription of long-acting muscarinic antagonist (LAMA) before and after educational visit in a six months period [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

12. Difference in change of prescription of LAMA before and after educational visit in one year [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

13. Difference in change of prescription of LAMA before and after educational visit as interrupted time series analysis [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

14. Difference in change of prescription of LAMA before and after educational visit for each month [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

15. Difference in change of cost of each medication group before and after educational visit in a six months period [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

16. Difference in change of cost of each medication group before and after educational visit in one year [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

17. Difference in change of cost of each medication group before and after educational visit as interrupted time series analysis [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

18. Difference in change of cost of each medication group before and after educational visit for each month [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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:

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital Bispebjerg and Frederiksberg	Copenhagen	Capital Region Of Denmark	Denmark	2400

Sponsors and Collaborators

• University Hospital Bispebjerg and Frederiksberg

Investigators

• Principal Investigator: Jon tt Andersen, MD, University Hospital Bispebjerg and Frederiksberg

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jón Þór Trærup Andersen, MD, University Hospital Bispebjerg and Frederiksberg
• ClinicalTrials.gov Identifier: NCT05442307
• Other Study ID Numbers: P-2021-709
• First Posted: Jul 5, 2022
• Last Update Posted: Jul 5, 2022
• Last Verified: Jun 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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

Study Results

No Results Posted as of Jul 5, 2022