OPTIM-EHPAD Optimization of Drug Prescription for Each Resident Entering in Nursing Home (EHPAD).

Iatrogenic Effect Clinical Trial

— OPTIM-EHPAD  

Official title:

Impact of a Consultation Between a Coordinating Physician and a Referring Physician About the Optimization of Drug Prescription for Each Resident Entering in Nursing Home (EHPAD).

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05179642
• Other study ID #: 69HCL17_0009
• Status: Active, not recruiting
• Start date: May 15, 2019
• Est. completion date: December 31, 2021

Study information

• Verified date: November 2021
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Elderly people are at high risk of multiple medication which increases drug interactions and side effects. This problem is accentuated in EHPAD due to the multiplication of prescribers (the referring physician, the hospital physician, the specialist, the emergency physician, the coordinating physician). The lack of optimization of drug prescriptions in EHPAD can be responsible for iatrogenic, underuse and overuse of treatment, impacting the autonomy and quality of life of residents in EHPAD in France.

A method for optimizing diagnostic and drug management at the entry of a new EHPAD resident, called OPTIM EHPAD, has been tested in Languedoc-Roussillon (France) and validated. This is a consultation between the referring physician and the EHPAD coordinating physician. Some improvements have been made to this method in order to have an optimized version.

Physician's cooperation seems to promote decision-making and change in therapies. The objective of this study is to assess the theoretical effectiveness and efficiency of this approach.

It is supposed that the provision to the EHPAD coordinating physician of a method for optimizing the diagnostic and drug management of the new EHPAD resident (based on a decision following consultation between the referring doctor and the coordinating doctor) would impact on the resident care process, on their care results and on communication and coordination between the coordinating physician and the referring physician.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 2000
• Est. completion date: December 31, 2021
• Est. primary completion date: October 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• - Coordinating physician of EHPAD who don't have an indoor pharmacy (PUI) from the Languedoc-Roussillon-Midi-Pyrénées region and the Auvergne-Rhône-Alpes region.

• New resident entering a participating EHPAD

Exclusion Criteria:

• - Residents who don't have a referring physician when entering EHPAD

Related Conditions & MeSH terms

• Iatrogenic Effect

Intervention

Other:
• OPTIM-EHPAD tool
This is a randomized, cluster stepped wedge study. Residents entering EHPAD during the pre-interventional inclusion period will be treated as usual in EHPAD. They will constitute the control group. Residents entering EHPAD during the post-intervention inclusion period will have the optimization of their diagnostic and drug management, following a consultation between their referring physician and the coordinating physician based on the OPTIM-EHPAD method. They will constitute the intervention group. The intervention is based on the utilization of the OPTIM-EHPAD method. It consists in training for coordinating physician and, optionally, for referring physician. It's a pedagogic tool proposing a rigorous methodology for reviewing prescriptions in chronological stages, associated with memos, constituting a form of clinical path for improving the quality and safety of prescriptions for EHPAD residents.

Locations

Country	Name	City	State
France	Hospices Civils de Lyon	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Inappropriate prescription line and average number of days of hospitalization	hierarchical sequential approach on the following criteria according to the predefined order : Proportion of residents with at least one inappropriate prescription line in residents' drug dispensations during months M3 to M6 following their entry into EHPAD.; Average number of days of hospitalization per resident in internal medicine/surgery/obstetrics wards, follow-up care and rehabilitation or in a psychiatric establishment during the 6 months following entry into EHPAD	6 months after the entering patient in EHPAD