Proton Pump Inhibitors (PPI): a Study to Improve Appropriate Prescriptions in the Elderly

NCT04637750 | Completed DMC

• 1 other identifier: GR-2016-02361198
• Study Type: interventional
• Target: 800
• Locations: 1 country
• Sites: 3

Brief Summary

Proton Pump Inhibitors(PPIs) are the leading evidence-based therapy for upper gastrointestinal disorders and prevention of antiplatelet or non-steroidal anti-inflammatory drugs induced ulcer. In Italy in 2015 nearly 3,5 millions of people were treated with PPI. Despite the extensive literature regarding PPI adverse event, their inappropriate prescription rate is still increasing, and Campania and Lombardy region are at the highest level. For this reason a cluster-randomised controlled trial will be performed, in order to evaluate if a low-cost informative intervention addressed to GPs is effective in improving PPIs prescription in older people. The threshold will be defined according to the distribution of the rate of appropriate PPI prescriptions for a 6 months lag time starting 1 year before randomisation (baseline assessment).

Conditions

Proton Pump Inhibitor; Primary Care

Keywords

Proton pump inhibitors; prescription appropriateness

Outcome Measures

Primary Outcomes (1)

• Short-term effectiveness

  Evaluate the short-term (6 months) effectiveness of a low-cost informative intervention in order to improve the appropriateness of prescription of PPI in older people in primary care in agreement with AIFA reimbursement rules by NHS in comparison to the daily clinical practice. Generalised linear mixed model, with a proper link function, on the differences in the proportion of inappropriate prescriptions of PPIs after 6 months from intervention with respect to the baseline, will be used to assess the intervention effectiveness.

  6 months

Secondary Outcomes (1)

• Long-term effectiveness

  12-18 months

Other Outcomes (1)

• Rate of 'paradoxical effect'

  12-18 months

Study Arms (2)

Educational intervention

EXPERIMENTAL

Randomised GPs will receive the low cost informative intervention composed by a practitioner-focused letter plus leaflet for patients

Behavioral: Educational intervention

Control group

NO INTERVENTION

GPs not receiving any informative intervention

Interventions

Educational intervention BEHAVIORAL

The GPs randomized to the intervention arm will receive a feedback informing on their absolute number of patients treated with at least one PPI during the baseline period and if they have been prescribed above or below the median of appropriate prescriptions rate in their local area. They will be also provided with a scientific document including technical details on AIFA reimbursement criteria (NOTA 1 and 48), short hints about adverse events related to PPI long- term use in older patients and recommendation on how to discontinue PPI therapy (i.e. gradual step down administration to avoid paradoxical effect).

Educational intervention

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• user of Proton Pump Inhibitors (at least one prescriptions in the period of interest)
• aged 65 or above

You may not qualify if:

• \- nursing homes residents

Sponsors & Collaborators

• Mario Negri Institute for Pharmacological Research: lead
• IRCCS Multimedica: collaborator
• Federico II University: collaborator

Study Sites (3)

IRCCS MultiMedica- MultiMedica Spa

Sesto San Giovanni, Milan, 20099, Italy

Location

Mario Negri Institute for Pharmacological Research

Milan, 20156, Italy

Location

Università degli studi di Napoli Federico II

Napoli, 80131, Italy

Location

MeSH Terms

Interventions

Early Intervention, Educational

Intervention Hierarchy (Ancestors)

Child Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services

Study Officials

• Carlotta Franchi, PhD

  Mario Negri Institute for Pharmacological Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2020
• First Posted: November 20, 2020
• Study Start: October 10, 2019
• Primary Completion: March 14, 2023
• Study Completion: March 14, 2024
• Last Updated: April 10, 2024

Record last verified: 2021-09

Locations

IT (3)