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

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ClinicalTrials.gov Identifier: NCT04637750
Recruitment Status : Active, not recruiting
First Posted : November 20, 2020
Last Update Posted : September 29, 2021
Sponsor:
Collaborators:
IRCCS Multimedica
Federico II University
Information provided by (Responsible Party):
Mario Negri Institute for Pharmacological Research

Tracking Information
First Submitted Date  ICMJE November 9, 2020
First Posted Date  ICMJE November 20, 2020
Last Update Posted Date September 29, 2021
Actual Study Start Date  ICMJE October 10, 2019
Estimated Primary Completion Date December 14, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 15, 2020)
Short-term effectiveness [ Time Frame: 6 months ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 15, 2020)
Long-term effectiveness [ Time Frame: 12-18 months ]
Evaluation of the persistence of the effectiveness of the intervention in the long-term at 12 and 18 months. Generalised linear mixed model, with a proper link function, on the differences in the proportion of inappropriate prescriptions of PPIs after 12-18 months from intervention with respect to the baseline, will be used to assess the intervention effectiveness.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: November 15, 2020)
Rate of 'paradoxical effect' [ Time Frame: 12-18 months ]
Evaluate the rate of 'paradoxical effect' (rebound acid hyper secretion) after gradual cessation of PPI therapy and the rate of the most frequent AEs (i.e. pneumonia, bone fractures, bacterial enteric infections, diminished vitamin absorption, gastric and colon cancer, myocardial infarction and overall mortality ).
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Proton Pump Inhibitors (PPI): a Study to Improve Appropriate Prescriptions in the Elderly
Official Title  ICMJE Evaluation of the Effectiveness of a Low-cost Informative Intervention to Improve the Appropriate Prescription of Proton Pump Inhibitors in Older People in Primary Care: a Cluster- Randomized Controlled Study
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).
Detailed Description A cluster-randomized 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. All GPs of the Local Health Unit (LHU) of Caserta (southern Italy) and Bergamo (northern Italy) will be invited to participate to the study, because Caserta and Bergamo represent the areas with the highest level of inappropriate PPI prescription rate. All GPs involved in the study will receive an invitation letter illustrating the study purpose and containing information about aggregated data on PPI prescriptions out of AIFA reimbursement criteria in Italy and their local area. The GPs randomized to the intervention arm will also 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. After 4 months GPs will also receive a patient-focused intervention leaflet and poster for patients about their medicines: what are the PPI and their possible side effects, nutritional and behavioral advices to prevent gastric and reflux problems and how to step down the treatment. The appropriateness of PPI prescriptions will be defined according to the Italian Medicines Agency (AIFA) reimbursement rules (NOTA 1 and 48).
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Proton Pump Inhibitor
  • Primary Care
Intervention  ICMJE Behavioral: Educational intervention
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).
Study Arms  ICMJE
  • Experimental: Educational intervention
    Randomised GPs will receive the low cost informative intervention composed by a practitioner-focused letter plus leaflet for patients
    Intervention: Behavioral: Educational intervention
  • No Intervention: Control group
    GPs not receiving any informative intervention
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: November 15, 2020)
800
Original Actual Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 14, 2023
Estimated Primary Completion Date December 14, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

All the GPs in Caserta and Bergamo will be invited to participate to the study by the local authorities.

Inclusion Criteria for GPs patients:

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

Exclusion Criteria:

- nursing homes residents

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04637750
Other Study ID Numbers  ICMJE GR-2016-02361198
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Mario Negri Institute for Pharmacological Research
Study Sponsor  ICMJE Mario Negri Institute for Pharmacological Research
Collaborators  ICMJE
  • IRCCS Multimedica
  • Federico II University
Investigators  ICMJE
Principal Investigator: Carlotta Franchi, PhD Mario Negri Institute for Pharmacological Research
PRS Account Mario Negri Institute for Pharmacological Research
Verification Date September 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP