Optimization of Drug Prescribing in an Elderly Population of Geriatric Consultations (OPTIM)

Optimization of Drug Prescribing in an Elderly Population of Geriatric Consultations and Living at Home

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.

Study Overview

• Status: Unknown
• Conditions: Functional Autonomy Level
• Intervention / Treatment: Other: Optimization of drug prescribing

• Study Type: Interventional
• Enrollment (Anticipated): 302
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dauphinot Virginie, Dr; Phone Number: 33 (0)4 72 43 20 50; Email: virginie.dauphinot@chu-lyon.fr
• Study Contact Backup: Name: Mouchoux Christelle, Dr; Phone Number: 33 (0)4 72 43 20 50; Email: christelle.mouchoux@chu-lyon.fr

Study Locations

• France
  • Albigny sur Saône, France
    • Not yet recruiting
    • Hôpital gériatrique du Mont d'Or
    • Contact: Aurélia MARFISI - DUBOST, PH
    • Sub-Investigator: Ahmed SALMI, PH
  • Lyon, France
    • Recruiting
    • Hôpital des charpennes
    • Contact: Pierre Krolak Salmon, PU PH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Hospitalizations	the occurrence of hospitalizations within 18 months after baseline	Baseline, 1 month, 6 months and 18 months
Number of days before hospitalizations	delay between baseline and the hospitalization	Baseline, 1 month, 6 months and 18 months
Occurrence of recourse to emergency service	occurrence of recourse to emergency service within 18 months after baseline	Baseline, 1 month, 6 months and 18 months
Number of days before the recourse to emergency service	delay between baseline and the recourse to emergency service	Baseline, 1 month, 6 months and 18 months
The occurrence of admission in institution	the occurrence of admission in institution within 18 months after baseline	Baseline, 1 month, 6 months and 18 months
Number of days before admission in institution	delay between baseline and the admission in institution	Baseline, 1 month, 6 months and 18 months
Death	the occurrence of death within 18 months after baseline	Baseline, 1 month, 6 months and 18 months
Number of days before death	delay between baseline and death	Baseline, 1 month, 6 months and 18 months
Falls	the occurrence of falls within 18 months after baseline	Baseline, 1 month, 6 months and 18 months
Number of days before falls	the delay between baseline and falls	Baseline, 1 month, 6 months and 18 months
Cognitive functions	The cognitive function is measured by the Mini Mental State Examination (MMSE) at every visit, as part of the routine care pathway of the patient. Successive scores will be used to measure the evolution of MMSE.	Baseline, 6 months and 18 months
Quality of life 1	Quality of life measured by questionnaire QoL-AD	Baseline, 6 months and 18 months
Quality of life 2	Quality of life measured by questionnaire EUROQOL 5D	Baseline, 6 months and 18 months
depression disorders	depression measured with the mini-GDS scale	Baseline, 6 months and 18 months
Anxiety disorders	Anxiety disorders will be measured with the Hamilton scale	Baseline, 6 months and 18 months
Compliance of patients with treatment	compliance is measured with the questionnaire Girerd	Baseline, 6 months and 18 months
Pain	Pain is measured with an ordinal scale from 0 to 10	Baseline, 6 months and 18 months
Proportion of potential inappropriate medication	The proportion of potential inappropriate medication will be measured on the drug prescribing of the patients issued from the referring physician	Baseline, 1 month, 6 months and 18 months
Problems associated with drug therapy	The proportion of problems associated with drug therapy will be measured on the drugs prescribing of the patients issued from the referring physician	Baseline, 1 month, 6 months and 18 months
acceptance rate by the referring physicians of pharmaceutical recommendation	The acceptance rate of the pharmaceutical review will be evaluated in 2 complementary ways: By comparing patients' prescriptions issued by the referring physician before and after the pharmaceutical review.; By interviewing the referring physician	Baseline, 1 month, 6 months and 18 months

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2016
• Primary Completion (Anticipated): November 1, 2020
• Study Completion (Anticipated): November 1, 2020

Study Registration Dates

• First Submitted: April 6, 2016
• First Submitted That Met QC Criteria: April 14, 2016
• First Posted (Estimate): April 15, 2016

Study Record Updates

• Last Update Posted (Actual): August 3, 2018
• Last Update Submitted That Met QC Criteria: August 2, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: elderly; Cognitive disorders; Functional autonomy level; Potentially inappropriate medication; Lawton Instrumental Activities of Daily Living; Optimization of drug prescribing
• Other Study ID Numbers: 69HCL15-0104