Optimization of Drug Prescribing in an Elderly Population of Geriatric Consultations

NCT02740764 | Unknown

• 1 other identifier: 69HCL15-0104
• Study Type: interventional
• Target: 302
• Locations: 1 country
• Sites: 2

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

Keywords

Functional autonomy level; Lawton Instrumental Activities of Daily Living; Cognitive disorders; Potentially inappropriate medication; elderly; Optimization of drug prescribing

Outcome Measures

Primary Outcomes (8)

• The evolution of the level of functional autonomy of the patients assessed using the scale IADL of Lawton

  The primary outcome will be calculated using the 4 successive evaluations of IADL scale. The IADL scale assesses the level of functional autonomy of a patient through the assessment of instrumental activities of daily living: ability to use the telephone, transportation, shopping, managing medications, manage a budget, prepare meals, maintain the house and do the laundry. The rating scale provides a score from 0 to 8. A higher score indicates a higher level of dependency, while a lower score reflects a lower level of dependence. The IADL scale consists of 8 questions.

  At inclusion

• The evolution of the level of functional autonomy of the patients assessed using the scale IADL of Lawton

  The primary outcome will be calculated using the 4 successive evaluations of IADL scale.

  At 1 month

• The evolution of the level of functional autonomy of the patients assessed using the scale IADL of Lawton

  The primary outcome will be calculated using the 4 successive evaluations of IADL scale.

  At 6 months

• The evolution of the level of functional autonomy of the patients assessed using the scale IADL of Lawton

  The primary outcome will be calculated using the 4 successive evaluations of IADL scale.

  At 18 months

• The evolution of the level of functional autonomy of the patients assessed using the scale DAD-6.

  The primary outcome will be calculated using the 4 successive evaluations of DAD-6 scale. The scale DAD-6 assesses the patient's activities in his daily life. It includes six questions assessing the degree of autonomy for the following activities: Food, use the telephone or the computer, moving outside, finance and correspondence, medications, leisure and home maintenance. The score ranges from 0 to 18 points, the higher the score, the more the patient is autonomous.

  At inclusion

• The evolution of the level of functional autonomy of the patients assessed using the scale DAD-6.

  The primary outcome will be calculated using the 4 successive evaluations of DAD-6 scale. The scale DAD-6 assesses the patient's activities in his daily life. It includes six questions assessing the degree of autonomy for the following activities: Food, use the telephone or the computer, moving outside, finance and correspondence, medications, leisure and home maintenance. The score ranges from 0 to 18 points, the higher the score, the more the patient is autonomous.

  At 1 month

• The evolution of the level of functional autonomy of the patients assessed using the scale DAD-6.

  The primary outcome will be calculated using the 4 successive evaluations of DAD-6 scale. The scale DAD-6 assesses the patient's activities in his daily life. It includes six questions assessing the degree of autonomy for the following activities: Food, use the telephone or the computer, moving outside, finance and correspondence, medications, leisure and home maintenance. The score ranges from 0 to 18 points, the higher the score, the more the patient is autonomous.

  At 6 months

• The evolution of the level of functional autonomy of the patients assessed using the scale DAD-6.

  The primary outcome will be calculated using the 4 successive evaluations of DAD-6 scale. The scale DAD-6 assesses the patient's activities in his daily life. It includes six questions assessing the degree of autonomy for the following activities: Food, use the telephone or the computer, moving outside, finance and correspondence, medications, leisure and home maintenance. The score ranges from 0 to 18 points, the higher the score, the more the patient is autonomous.

  At 18 months

Secondary Outcomes (20)

• Number of Hospitalizations

  Baseline, 1 month, 6 months and 18 months

• Number of days before hospitalizations

  Baseline, 1 month, 6 months and 18 months

• Occurrence of recourse to emergency service

  Baseline, 1 month, 6 months and 18 months

• Number of days before the recourse to emergency service

  Baseline, 1 month, 6 months and 18 months

• The occurrence of admission in institution

  Baseline, 1 month, 6 months and 18 months

Study Arms (2)

Optimization of drug prescribing

EXPERIMENTAL

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.

Other: Optimization of drug prescribing

No intervention

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.

Interventions

Optimization of drug prescribing 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.

Optimization of drug prescribing

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (2)

Hôpital gériatrique du Mont d'Or

Albigny-sur-Saône, France

NOT YET RECRUITING

Hôpital des Charpennes

Lyon, France

RECRUITING

Related Publications (1)

• 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.

  PMID: 28854884 DERIVED

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Dauphinot Virginie, Dr

CONTACT

33 (0)4 72 43 20 50; virginie.dauphinot@chu-lyon.fr

Mouchoux Christelle, Dr

CONTACT

33 (0)4 72 43 20 50; christelle.mouchoux@chu-lyon.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2016
• First Posted: April 15, 2016
• Study Start: May 1, 2016
• Primary Completion: November 1, 2020
• Study Completion: November 1, 2020
• Last Updated: August 3, 2018

Record last verified: 2018-08

Locations

FR (2)