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Optimization of Drug Prescribing in an Elderly Population of Geriatric Consultations

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02740764
Acronym
OPTIM
Enrollment
302
Registered
2016-04-15
Start date
2016-05-31
Completion date
2020-11-30
Last updated
2018-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Functional Autonomy Level

Keywords

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

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.

Interventions

OTHEROptimization 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.

Sponsors

Hospices Civils de Lyon
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

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;

Design outcomes

Primary

MeasureTime frameDescription
The evolution of the level of functional autonomy of the patients assessed using the scale IADL of LawtonAt inclusionThe 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.
The evolution of the level of functional autonomy of the patients assessed using the scale DAD-6.At inclusionThe 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.

Secondary

MeasureTime frameDescription
Occurrence of recourse to emergency serviceBaseline, 1 month, 6 months and 18 monthsoccurrence of recourse to emergency service within 18 months after baseline
Number of days before the recourse to emergency serviceBaseline, 1 month, 6 months and 18 monthsdelay between baseline and the recourse to emergency service
The occurrence of admission in institutionBaseline, 1 month, 6 months and 18 monthsthe occurrence of admission in institution within 18 months after baseline
Number of days before admission in institutionBaseline, 1 month, 6 months and 18 monthsdelay between baseline and the admission in institution
DeathBaseline, 1 month, 6 months and 18 monthsthe occurrence of death within 18 months after baseline
Number of days before deathBaseline, 1 month, 6 months and 18 monthsdelay between baseline and death
FallsBaseline, 1 month, 6 months and 18 monthsthe occurrence of falls within 18 months after baseline
Number of days before fallsBaseline, 1 month, 6 months and 18 monthsthe delay between baseline and falls
Cognitive functionsBaseline, 6 months and 18 monthsThe 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.
Number of HospitalizationsBaseline, 1 month, 6 months and 18 monthsthe occurrence of hospitalizations within 18 months after baseline
Quality of life 2Baseline, 6 months and 18 monthsQuality of life measured by questionnaire EUROQOL 5D
depression disordersBaseline, 6 months and 18 monthsdepression measured with the mini-GDS scale
Anxiety disordersBaseline, 6 months and 18 monthsAnxiety disorders will be measured with the Hamilton scale
Compliance of patients with treatmentBaseline, 6 months and 18 monthscompliance is measured with the questionnaire Girerd
PainBaseline, 6 months and 18 monthsPain is measured with an ordinal scale from 0 to 10
Proportion of potential inappropriate medicationBaseline, 1 month, 6 months and 18 monthsThe proportion of potential inappropriate medication will be measured on the drug prescribing of the patients issued from the referring physician
Problems associated with drug therapyBaseline, 1 month, 6 months and 18 monthsThe proportion of problems associated with drug therapy will be measured on the drugs prescribing of the patients issued from the referring physician
acceptance rate by the referring physicians of pharmaceutical recommendationBaseline, 1 month, 6 months and 18 monthsThe 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
Quality of life 1Baseline, 6 months and 18 monthsQuality of life measured by questionnaire QoL-AD
Number of days before hospitalizationsBaseline, 1 month, 6 months and 18 monthsdelay between baseline and the hospitalization

Countries

France

Contacts

Primary ContactDauphinot Virginie, Dr
virginie.dauphinot@chu-lyon.fr33 (0)4 72 43 20 50
Backup ContactMouchoux Christelle, Dr
christelle.mouchoux@chu-lyon.fr33 (0)4 72 43 20 50

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026