Clinical trial NCT02740764: Optimization of Drug Prescribing in an Elderly Population of Geriatric Consultations
Official title: Optimization of Drug Prescribing in an Elderly Population of Geriatric Consultations and Living at Home
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Functional Autonomy Level
Keywords: Functional autonomy level
Lawton Instrumental Activities of Daily Living
Cognitive disorders
Potentially inappropriate medication
elderly
Optimization of drug prescribing
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2016-04-15
Enrollment: 302
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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;

Primary outcomes:
measure: The evolution of the level of functional autonomy of the patients assessed using the scale IADL of Lawton
timeFrame: At inclusion
measure: The evolution of the level of functional autonomy of the patients assessed using the scale IADL of Lawton
timeFrame: At 1 month
measure: The evolution of the level of functional autonomy of the patients assessed using the scale IADL of Lawton
timeFrame: At 6 months
measure: The evolution of the level of functional autonomy of the patients assessed using the scale IADL of Lawton
timeFrame: At 18 months
measure: The evolution of the level of functional autonomy of the patients assessed using the scale DAD-6.
timeFrame: At inclusion
measure: The evolution of the level of functional autonomy of the patients assessed using the scale DAD-6.
timeFrame: At 1 month
measure: The evolution of the level of functional autonomy of the patients assessed using the scale DAD-6.
timeFrame: At 6 months
measure: The evolution of the level of functional autonomy of the patients assessed using the scale DAD-6.
timeFrame: At 18 months
Secondary outcomes:
measure: Number of Hospitalizations
timeFrame: Baseline, 1 month, 6 months and 18 months
measure: Number of days before hospitalizations
timeFrame: Baseline, 1 month, 6 months and 18 months
measure: Occurrence of recourse to emergency service
timeFrame: Baseline, 1 month, 6 months and 18 months
measure: Number of days before the recourse to emergency service
timeFrame: Baseline, 1 month, 6 months and 18 months
measure: The occurrence of admission in institution
timeFrame: Baseline, 1 month, 6 months and 18 months
measure: Number of days before admission in institution
timeFrame: Baseline, 1 month, 6 months and 18 months
measure: Death
timeFrame: Baseline, 1 month, 6 months and 18 months
measure: Number of days before death
timeFrame: Baseline, 1 month, 6 months and 18 months
measure: Falls
timeFrame: Baseline, 1 month, 6 months and 18 months
measure: Number of days before falls
timeFrame: Baseline, 1 month, 6 months and 18 months
measure: Cognitive functions
timeFrame: Baseline, 6 months and 18 months
measure: Quality of life 1
timeFrame: Baseline, 6 months and 18 months
measure: Quality of life 2
timeFrame: Baseline, 6 months and 18 months
measure: depression disorders
timeFrame: Baseline, 6 months and 18 months
measure: Anxiety disorders
timeFrame: Baseline, 6 months and 18 months
measure: Compliance of patients with treatment
timeFrame: Baseline, 6 months and 18 months
measure: Pain
timeFrame: Baseline, 6 months and 18 months
measure: Proportion of potential inappropriate medication
timeFrame: Baseline, 1 month, 6 months and 18 months
measure: Problems associated with drug therapy
timeFrame: Baseline, 1 month, 6 months and 18 months
measure: acceptance rate by the referring physicians of pharmaceutical recommendation
timeFrame: Baseline, 1 month, 6 months and 18 months
Other outcomes:
Locations:
city: Albigny sur Saône
country: France
facility: Hôpital gériatrique du Mont d'Or
city: Lyon
country: France
facility: Hôpital des Charpennes
Study officials:
References:
citation: 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.