Effectiveness of a Postal Intervention to Improve the Use of PPI

• Sponsor: Osakidetza (Other)
• Overall Status: Completed
• CT.gov ID: NCT03840018
• Collaborator: (none)
• Enrollment: 401
• Location: 1
• Arms: 2
• Actual Duration (Months): 11.3
• Patients Per Site Per Month: 35.6

Study Details

Study Description

Brief Summary

It was a randomised intervention study, with before-and-after outcome measures and a control group, in patients who had an active long-term prescription for PPIs at high doses for at least 6 months.

Condition or Disease	Intervention/Treatment	Phase
Drug Overdose	Other: Letter by post to patients	N/A

Detailed Description

The intervention consisted of sending patients an informative letter by post, in which their doctor invited them to seek an appointment for a medication review. Control group patients did not receive such a letter, and they were treated as usual (their doctors received a list of identifiers of patients on high doses).

The main outcome variable was the number of active prescriptions of each PPI dose (high dose/standard dose/treatment cessation) at 6 months after the intervention.

Study Design

• Study Type: Interventional
• Actual Enrollment: 401 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Care Provider)
• Primary Purpose: Other
• Official Title: Randomized Trial to Assess the Effectiveness of a Postal Intervention for Reducing the Chronic Use of Highe Doses of Proton Pump Inhibitors
• Actual Study Start Date: May 10, 2017
• Actual Primary Completion Date: Dec 10, 2017
• Actual Study Completion Date: Apr 18, 2018

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Control Sending doctors the lists of patients that meet the inclusion criteria to have their treatment reviewed
Other: Letter by post to patients Patients were sent a letter explaining the risks of using PPIs at long-term high doses and encouraging them to visit their doctor	Other: Letter by post to patients; Patients received an informative letter by post, in which their doctor invited them to seek an appointment for a medication review

Outcome Measures

Primary Outcome Measures

1. Active prescriptions of each proton pump inhibitors dose after the intervention [6 months]

   Number of active prescriptions of each proton pump inhibitors dose (high dose/standard dose/treatment cessation) at 6 months after the intervention

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients under the care of our organisation who in May 2017 had an active long-term prescription for PPIs at high doses for at least 6 months.

Exclusion Criteria:

• Patients whose GPs declined to participate

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Bidasoa Integrated Health Organization	Hondarribia	Gipuzkoa	Spain	20270

Sponsors and Collaborators

• Osakidetza

Investigators

• Principal Investigator: Elena Valverde, Osakidetza

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Elena Valverde, Primary care pharmacist, Osakidetza
• ClinicalTrials.gov Identifier: NCT03840018
• Other Study ID Numbers: EVB-IBP-2017-01
• First Posted: Feb 15, 2019
• Last Update Posted: Feb 15, 2019
• Last Verified: Feb 1, 2019

• 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
• Additional relevant MeSH terms: Drug Overdose

Study Results

No Results Posted as of Feb 15, 2019