NCT05179642

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 15, 2019

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2020

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

November 8, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 5, 2022

Completed
Last Updated

January 5, 2022

Status Verified

November 1, 2021

Enrollment Period

1.4 years

First QC Date

November 8, 2021

Last Update Submit

December 16, 2021

Conditions

Keywords

coordinating physicianreferring physicianoptimization of drug prescriptionnursing homeinappropriate prescription

Outcome Measures

Primary Outcomes (1)

  • Inappropriate prescription line and average number of days of hospitalization

    hierarchical sequential approach on the following criteria according to the predefined order : 1. Proportion of residents with at least one inappropriate prescription line in residents' drug dispensations during months M3 to M6 following their entry into EHPAD. 2. 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

Study Arms (2)

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

Interventions

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.

Tool OPTIM-EHPAD

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The eligible population is made up of EHPAD coordinating physicians who don't have an indoor pharmacy (PUI) from the Languedoc-Roussillon-Midi-Pyrénées region and the Auvergne-Rhône-Alpes region. Any new resident entering a participating EHPAD. Residents who don't have a referring physician when entering EHPAD will be excluded.

You may qualify if:

  • \- 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospices Civils de Lyon

Lyon, France

Location

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 8, 2021

First Posted

January 5, 2022

Study Start

May 15, 2019

Primary Completion

October 15, 2020

Study Completion

December 31, 2021

Last Updated

January 5, 2022

Record last verified: 2021-11

Locations