Proton Pump Inhibitors (PPI): a Study to Improve Appropriate Prescriptions in the Elderly (LAPTOP-PPI)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04637750|
Recruitment Status : Active, not recruiting
First Posted : November 20, 2020
Last Update Posted : September 29, 2021
|Condition or disease||Intervention/treatment||Phase|
|Proton Pump Inhibitor Primary Care||Behavioral: Educational intervention||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||800 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Actual Study Start Date :||October 10, 2019|
|Estimated Primary Completion Date :||December 14, 2021|
|Estimated Study Completion Date :||March 14, 2023|
Experimental: Educational intervention
Randomised GPs will receive the low cost informative intervention composed by a practitioner-focused letter plus leaflet for patients
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).
No Intervention: Control group
GPs not receiving any informative intervention
- 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.
- 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.
- 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 ).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04637750
|IRCCS MultiMedica- MultiMedica Spa|
|Sesto San Giovanni, Milan, Italy, 20099|
|Mario Negri Institute for Pharmacological Research|
|Milan, Italy, 20156|
|Università degli studi di Napoli Federico II|
|Napoli, Italy, 80131|
|Principal Investigator:||Carlotta Franchi, PhD||Mario Negri Institute for Pharmacological Research|