Elderly Appropriate Treatment in Primary Care (EAT) (TAPAGE)
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|ClinicalTrials.gov Identifier: NCT03298386|
Recruitment Status : Recruiting
First Posted : October 2, 2017
Last Update Posted : October 19, 2017
|Condition or disease||Intervention/treatment||Phase|
|Elderly Polypharmacy||Other: Systematic medication review with the STOPP/START tool||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||3032 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Elderly Appropriate Treatment in Primary Care (EAT)|
|Actual Study Start Date :||August 1, 2017|
|Estimated Primary Completion Date :||October 2019|
|Estimated Study Completion Date :||October 2019|
Experimental: Intervention Group "STOPP/START"
Training of General Practitioners with the tool STOPP/START Systematic medication review by GP with STOPP/START
Other: Systematic medication review with the STOPP/START tool
The STOPP / START tool includes a list of 42 substances / drug classes whose prescription could be discontinued based on specific criteria (81 STOPP criteria: Screening Tool of Older Person's Prescriptions) and a list of 34 clinical situations involving consideration of the usefulness of a new prescription (START criteria: Screening Tool to Action the Right Treatment).
No Intervention: Control group
Patient's usual care by the general practitioner (who will not be trained in the STOPP/START tool)
- A composite criterion: - percentage of unplanned hospitalization - percentage of death regardless of cause, - percentage of emergency department visit - percentage of institutionalization [ Time Frame: at 12 months ]
The primary outcome measure will be a composite criterion comprising unplanned hospitalization, death regardless of cause, emergency department visits and institutionalization after 12 months of follow-up.
Unplanned hospitalization is defined as either hospitalization decided after a visit to the emergency department (whether the patient was sent by a doctor or not) or hospitalization decided on the same day by the general practitioner.
- Percentage of unplanned hospitalization [ Time Frame: at 12 months ]
- Percentage of death regardless of cause [ Time Frame: at 12 months ]
- Percentage of emergency department visits [ Time Frame: at 12 months ]
- Percentage of institutionalization [ Time Frame: at 12 months ]
- Percentage of loss of autonomy [ Time Frame: at 12 months ]The loss of autonomy at 12 months defined by the loss of at least one activity of the daily living (ADL) between the intervention and 12 months of follow-up.
- Decrease in the number of drugs on the prescription (%) [ Time Frame: at 12 months ]The decrease in the number of drugs on the prescription (Polypharmacy decrease) between baseline and 12 months of follow-up
- Percentage of falls [ Time Frame: at 12 months ]
- Percentage of recommendations followed [ Time Frame: at 12 months ]
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): NCT03298386
|Clinical Epidemiology and Ageing (CEpiA) EA7376 Faculté de Médecine, Université Paris Est Créteil (UPEC)||Recruiting|
|Créteil, France, 94010|
|Contact: Akim SOUAG (0)1 44 84 17 15 ext +33 email@example.com|
|Principal Investigator:||Julien Le Breton||Assistance Publique - Hôpitaux de Paris|