Optimization of Drug Prescribing in an Elderly Population of Geriatric Consultations

NCT ID: NCT02740764

Last Updated: 2018-08-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 302 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-31
• Study Completion Date: 2020-11-30

Brief Summary

Aging is often associated with multiple chronic conditions conducting increased consumption of drugs. Drug therapy is necessary for the treatment of many diseases. However, misuse of drugs, particularly linked to the potentially inappropriate prescribing and polypharmacy, increases the iatrogenic risks and can lead to adverse events such as falls, cognitive decline, increased use to the health system: hospital admissions, emergency room visits, and institutionalization. These problems are common since about 20% of emergency room use in elderly patients due to an adverse event related to drugs. Nearly 28% of adverse events related to drug prescriptions could be avoided.

Interventions to optimize drug therapy showed a reduction in the number of potentially inappropriate medications, but their impact on health, has rarely been evaluated. If an association with death has been established, the link with the loss of functional autonomy, which leads to reduced quality of life and significant cost of care, has not been investigated. The evolution towards functional disabilities, frequent with aging has many causes, among which some could be prevented. The optimization of drug prescriptions could thereby delay or prevent the loss of functional autonomy by reducing the risk of adverse events, such as falls or cognitive decline and improving the management of chronic diseases. Our hypothesis is that an optimization program of the drug prescribing may slow progression to functional dependence. To assess the effect of the optimization program of drug prescribing on the level of functional autonomy, a multicenter Randomized Controlled Trial will be conducted in geriatric and memory consultations.

Expected results The implementation of the "OPTIM" program should enable optimization of drug prescribing in elderly patients and therefore slow or prevent progression to addiction. It should also help to develop and strengthen collaboration and communication between the team of geriatric consultation, the clinician pharmacist and referring physicians in town (private practice). In addition, pharmaceutical notice sent to referring physicians should help raise awareness of the prescription of drugs in these patients.

Conditions

Functional Autonomy Level

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Optimization of drug prescribing

The group with optimization program will have: (i) a medical history of the drug prescribing; (ii) analysis and pharmaceutical recommendations and (iii) preparation of a management plan. Notices will be sent only to referring physicians in this experimental group.

Group Type: EXPERIMENTAL

Optimization of drug prescribing

Intervention Type: OTHER

The patients included in this group will have the intervention. The optimization of drug prescribing consists to a history of the drugs prescribing leading to pharmaceutical recommendations by the pharmacist-clinician, accepted by the specialist physicians in charge of the patient at the hospital and sent to the referring physicians of patients, who can accept or not the recommendations.

No intervention

This group will receive the current management of patients in geriatric or memory consultation, during which the intervention of a clinician pharmacist is not provided. There will be a history of the drugs prescribing leading to pharmaceutical recommendations by the pharmacist-clinician, accepted by the specialist physicians in charge of the patient at the hospital, but the recommendations will not be transmitted to the referring physicians of patients.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Optimization of drug prescribing

The patients included in this group will have the intervention. The optimization of drug prescribing consists to a history of the drugs prescribing leading to pharmaceutical recommendations by the pharmacist-clinician, accepted by the specialist physicians in charge of the patient at the hospital and sent to the referring physicians of patients, who can accept or not the recommendations.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patients aged 65 and over;
• Patients received for the first time in a geriatric or memory consultation of a study recruiting centers;
• Patients living at home;
• Patients with the ability to express themselves orally or in writing in French sufficiently to carry out clinical assessments;
• Patients who led the last drugs prescription from his referring physician, at the geriatric/memory consultation (in current practice, patients should take the last prescription established by the referring physician);
• Patients accompanied by a caregiver.

Exclusion Criteria

• Patients with no discernment;
• Patient put under legal protection;

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hôpital gériatrique du Mont d'Or

Albigny-sur-Saône, , France

Site Status: NOT_YET_RECRUITING

Hôpital des Charpennes

Lyon, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Dauphinot Virginie, Dr

Role: CONTACT

virginie.dauphinot@chu-lyon.fr

33 (0)4 72 43 20 50

Mouchoux Christelle, Dr

Role: CONTACT

christelle.mouchoux@chu-lyon.fr

33 (0)4 72 43 20 50

Facility Contacts

Aurélia MARFISI - DUBOST, PH

Role: primary

Pierre Krolak Salmon, PU PH

Role: primary

References

Dauphinot V, Jean-Bart E, Krolak-Salmon P, Mouchoux C. A multi-center, randomized, controlled trial to assess the efficacy of optimization of drug prescribing in an elderly population, at 18 months of follow-up, in the evolution of functional autonomy: the OPTIM study protocol. BMC Geriatr. 2017 Aug 30;17(1):195. doi: 10.1186/s12877-017-0600-7.

Reference Type: DERIVED

PMID: 28854884 (View on PubMed)

Other Identifiers

69HCL15-0104

Identifier Type: -

Identifier Source: org_study_id