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

Sponsor
Hospices Civils de Lyon (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05179642
Collaborator
(none)
2,000
1
31.6
63.3

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: OPTIM-EHPAD tool

Study Design

Study Type:
Observational
Anticipated Enrollment :
2000 participants
Observational Model:
Other
Time Perspective:
Prospective
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).
Actual Study Start Date :
May 15, 2019
Actual Primary Completion Date :
Oct 15, 2020
Anticipated Study Completion Date :
Dec 31, 2021

Arms and Interventions

Arm Intervention/Treatment
Control group

This is a randomized, cluster stepped wedge study. The cluster will be made up of coordinating physicians grouped together according to the geographical area of their EHPAD. Residents entering EHPAD during the pre-interventional inclusion period will be treated as usual in EHPAD. They will constitute the control group.

Tool OPTIM-EHPAD

This is a randomized, cluster stepped wedge study. The cluster will be made up of coordinating physicians grouped together according to the geographical area of their EHPAD. 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.

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.

Outcome Measures

Primary Outcome Measures

  1. Inappropriate prescription line and average number of days of hospitalization [6 months after the entering patient in EHPAD]

    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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hospices Civils de Lyon Lyon France

Sponsors and Collaborators

  • Hospices Civils de Lyon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT05179642
Other Study ID Numbers:
  • 69HCL17_0009
First Posted:
Jan 5, 2022
Last Update Posted:
Jan 5, 2022
Last Verified:
Nov 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Hospices Civils de Lyon

Study Results

No Results Posted as of Jan 5, 2022