Optimization of Drug Prescribing in an Elderly Population of Geriatric Consultations
- Conditions
- Functional Autonomy Level
- Interventions
- Other: Optimization of drug prescribing
- Registration Number
- NCT02740764
- Lead Sponsor
- Hospices Civils de Lyon
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 302
- 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.
- Patients with no discernment;
- Patient put under legal protection;
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Optimization of drug prescribing 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.
- Primary Outcome Measures
Name Time Method The evolution of the level of functional autonomy of the patients assessed using the scale DAD-6. At 18 months 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.The evolution of the level of functional autonomy of the patients assessed using the scale IADL of Lawton At 18 months The primary outcome will be calculated using the 4 successive evaluations of IADL scale.
- Secondary Outcome Measures
Name Time Method Compliance of patients with treatment Baseline, 6 months and 18 months compliance is measured with the questionnaire Girerd
Occurrence of recourse to emergency service Baseline, 1 month, 6 months and 18 months occurrence of recourse to emergency service within 18 months after baseline
Number of days before falls Baseline, 1 month, 6 months and 18 months the delay between baseline and falls
acceptance rate by the referring physicians of pharmaceutical recommendation Baseline, 1 month, 6 months and 18 months 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 physicianNumber of Hospitalizations Baseline, 1 month, 6 months and 18 months the occurrence of hospitalizations within 18 months after baseline
Number of days before hospitalizations Baseline, 1 month, 6 months and 18 months delay between baseline and the hospitalization
Number of days before admission in institution Baseline, 1 month, 6 months and 18 months delay between baseline and the admission in institution
Quality of life 1 Baseline, 6 months and 18 months Quality of life measured by questionnaire QoL-AD
Number of days before the recourse to emergency service Baseline, 1 month, 6 months and 18 months delay between baseline and the recourse to emergency service
The occurrence of admission in institution Baseline, 1 month, 6 months and 18 months the occurrence of admission in institution within 18 months after baseline
Falls Baseline, 1 month, 6 months and 18 months the occurrence of falls within 18 months after baseline
Cognitive functions Baseline, 6 months and 18 months 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.
Problems associated with drug therapy Baseline, 1 month, 6 months and 18 months The proportion of problems associated with drug therapy will be measured on the drugs prescribing of the patients issued from the referring physician
Death Baseline, 1 month, 6 months and 18 months the occurrence of death within 18 months after baseline
Number of days before death Baseline, 1 month, 6 months and 18 months delay between baseline and death
Quality of life 2 Baseline, 6 months and 18 months Quality of life measured by questionnaire EUROQOL 5D
depression disorders Baseline, 6 months and 18 months depression measured with the mini-GDS scale
Anxiety disorders Baseline, 6 months and 18 months Anxiety disorders will be measured with the Hamilton scale
Proportion of potential inappropriate medication Baseline, 1 month, 6 months and 18 months The proportion of potential inappropriate medication will be measured on the drug prescribing of the patients issued from the referring physician
Pain Baseline, 6 months and 18 months Pain is measured with an ordinal scale from 0 to 10
Trial Locations
- Locations (2)
H么pital g茅riatrique du Mont d'Or
馃嚝馃嚪Albigny sur Sa么ne, France
H么pital des Charpennes
馃嚝馃嚪Lyon, France