Academic Detailing About Proton Pump Inhibitors (BRIEF-PI)

Boosting General Practice pRescription by Individual Educational Fast Academic Detailing Visits About Proton Pump Inhibitor

General practices in the Capital Region of Denmark are offered a short educational visit and are randomized to either proton pump inhibitor (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: Prescription Pattern
• Intervention / Treatment: Behavioral: Other education; Behavioral: Proton pump inhibitor education

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 proton pump inhibitor (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

• Study Contact: Name: jon t.t. Andersen, MD; Phone Number: +45 38 63 57 26; Email: jon.thor.traerup.andersen@regionh.dk

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: Yes
• 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

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Proton pump inhibitor education; The general practices in this arm will receive the education visits about Proton pump inhibitor.	Behavioral: Proton pump inhibitor education; A 15 minutes (preferable) one-on-one educational visit about deprescription of proton pump inhibitor
PLACEBO_COMPARATOR: Other education; The general practices in this arm will receive an educational visit on another topic (asthma).	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 number of adult patients with redeemed prescriptions on proton pump inhibitor between asthma-group and placebo-group in a six months period	Difference in change of number of adult patients with redeemed prescriptions on proton pump inhibitor 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 number of adult patients with redeemed prescriptions on proton pump inhibitor between asthma-group and placebo-group in a one year period	Difference in change of number of adult patients with redeemed prescriptions on proton pump inhibitor between asthma-group and placebo-group	one year before and one year after educational visit
Difference in change of number of adult patients with redeemed prescriptions on proton pump inhibitor between asthma-group and placebo-group in a one year perioid as interrupted time series analysis	Difference in change of number of adult patients with redeemed prescriptions on proton pump inhibitor between asthma-group and placebo-group as interrupted time series analysis	one year before and one year after educational visit
Difference in change of number of adult patients with redeemed prescriptions on proton pump inhibitor between asthma-group and placebo-group analyzed by each month in relation to the visit in one year	Difference in change of number of adult patients with redeemed prescriptions on proton pump inhibitor 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 (DDD) of PPI before and after educational visit in a six months period	Difference in change of defined daily dosages (DDD) of proton pump inhibitor to adult patients between asthma-group and placebo-group	6-0 months before and 6-12 months after educational visit
Difference in change of prescription (DDD) of PPI before and after educational visit in one year	Difference in change of defined daily dosages (DDD) of proton pump inhibitor to adult patients between asthma-group and placebo-group	one year before and one year after educational visit
Difference in change of prescription (DDD) of PPI before and after educational visit in one year as interrupted time series analysis	Difference in change of defined daily dosages (DDD) of proton pump inhibitor to adult patients 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 (DDD) of PPI before and after educational visit in one year for each month	Difference in change of defined daily dosages (DDD) of proton pump inhibitor to adult patients 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 (DDD) of antacid before and after educational visit in a six months period	Difference in change of defined daily dosages (DDD) of antacid to adult patients between asthma-group and placebo-group	6-0 months before and 6-12 months after educational visit
Difference in change of prescription (DDD) of antacid before and after educational visit in one year	Difference in change of defined daily dosages (DDD) of antacid to adult patients between asthma-group and placebo-group	one year before and one year after educational visit
Difference in change of prescription (DDD) of antacid before and after educational visit in one year as interrupted time series analysis	Difference in change of defined daily dosages (DDD) of antacid to adult patients 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 (DDD) of antacid before and after educational visit in one year for each month	Difference in change of defined daily dosages (DDD) of antacid to adult patients 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 numbers of big packages of PPI before and after educational visit in a six months period	Difference in change numbers of big packages (90 pcs or more) of PPI in highest dosage strength to adult patients between asthma-group and placebo-group	6-0 months before and 6-12 months after educational visit
Difference in change of numbers of big packages of PPI before and after educational visit in one year	Difference in change numbers of big packages (90 pcs or more) of PPI in highest dosage strength to adult patients between asthma-group and placebo-group	one year before and one year after educational visit
Difference in change of numbers of big packages of PPI before and after educational visit in one year as interrupted time series analysis	Difference in change numbers of big packages (90 pcs or more) of PPI in highest dosage strength to adult patients between asthma-group and placebo-group as interrupted time series analysis	one year before and one year after educational visit
Difference in change of numbers of big packages of PPI before and after educational visit in one year for each month	Difference in change numbers of big packages (90 pcs or more) of PPI in highest dosage strength to adult patients 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

• Sponsor: Jón Þór Trærup Andersen

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 6, 2021
• Primary Completion (ANTICIPATED): July 1, 2023
• Study Completion (ANTICIPATED): October 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

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Proton Pump Inhibitors
• Other Study ID Numbers: P-2021-709b

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