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.
調査の概要
研究の種類
入学 (予想される)
段階
- 適用できない
連絡先と場所
研究場所
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Albigny sur Saône、フランス
- まだ募集していません
- Hôpital gériatrique du Mont d'Or
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コンタクト：
- Aurélia MARFISI - DUBOST, PH
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副調査官：
- Ahmed SALMI, PH
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Lyon、フランス
- 募集
- Hopital des Charpennes
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コンタクト：
- Pierre Krolak Salmon, PU PH
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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;
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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.
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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.
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介入なし：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.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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The evolution of the level of functional autonomy of the patients assessed using the scale IADL of Lawton
時間枠：At inclusion
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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
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The evolution of the level of functional autonomy of the patients assessed using the scale IADL of Lawton
時間枠：At 1 month
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The primary outcome will be calculated using the 4 successive evaluations of IADL scale.
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At 1 month
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The evolution of the level of functional autonomy of the patients assessed using the scale IADL of Lawton
時間枠：At 6 months
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The primary outcome will be calculated using the 4 successive evaluations of IADL scale.
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At 6 months
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The evolution of the level of functional autonomy of the patients assessed using the scale IADL of Lawton
時間枠：At 18 months
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The primary outcome will be calculated using the 4 successive evaluations of IADL scale.
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At 18 months
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The evolution of the level of functional autonomy of the patients assessed using the scale DAD-6.
時間枠：At inclusion
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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
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The evolution of the level of functional autonomy of the patients assessed using the scale DAD-6.
時間枠：At 1 month
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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
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The evolution of the level of functional autonomy of the patients assessed using the scale DAD-6.
時間枠：At 6 months
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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
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The evolution of the level of functional autonomy of the patients assessed using the scale DAD-6.
時間枠：At 18 months
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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
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Number of Hospitalizations
時間枠：Baseline, 1 month, 6 months and 18 months
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the occurrence of hospitalizations within 18 months after baseline
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Baseline, 1 month, 6 months and 18 months
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Number of days before hospitalizations
時間枠：Baseline, 1 month, 6 months and 18 months
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delay between baseline and the hospitalization
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Baseline, 1 month, 6 months and 18 months
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Occurrence of recourse to emergency service
時間枠：Baseline, 1 month, 6 months and 18 months
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occurrence of recourse to emergency service within 18 months after baseline
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Baseline, 1 month, 6 months and 18 months
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Number of days before the recourse to emergency service
時間枠：Baseline, 1 month, 6 months and 18 months
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delay between baseline and the recourse to emergency service
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Baseline, 1 month, 6 months and 18 months
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The occurrence of admission in institution
時間枠：Baseline, 1 month, 6 months and 18 months
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the occurrence of admission in institution within 18 months after baseline
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Baseline, 1 month, 6 months and 18 months
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Number of days before admission in institution
時間枠：Baseline, 1 month, 6 months and 18 months
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delay between baseline and the admission in institution
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Baseline, 1 month, 6 months and 18 months
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Death
時間枠：Baseline, 1 month, 6 months and 18 months
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the occurrence of death within 18 months after baseline
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Baseline, 1 month, 6 months and 18 months
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Number of days before death
時間枠：Baseline, 1 month, 6 months and 18 months
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delay between baseline and death
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Baseline, 1 month, 6 months and 18 months
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Falls
時間枠：Baseline, 1 month, 6 months and 18 months
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the occurrence of falls within 18 months after baseline
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Baseline, 1 month, 6 months and 18 months
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Number of days before falls
時間枠：Baseline, 1 month, 6 months and 18 months
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the delay between baseline and falls
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Baseline, 1 month, 6 months and 18 months
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Cognitive functions
時間枠：Baseline, 6 months and 18 months
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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.
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Baseline, 6 months and 18 months
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Quality of life 1
時間枠：Baseline, 6 months and 18 months
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Quality of life measured by questionnaire QoL-AD
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Baseline, 6 months and 18 months
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Quality of life 2
時間枠：Baseline, 6 months and 18 months
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Quality of life measured by questionnaire EUROQOL 5D
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Baseline, 6 months and 18 months
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depression disorders
時間枠：Baseline, 6 months and 18 months
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depression measured with the mini-GDS scale
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Baseline, 6 months and 18 months
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Anxiety disorders
時間枠：Baseline, 6 months and 18 months
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Anxiety disorders will be measured with the Hamilton scale
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Baseline, 6 months and 18 months
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Compliance of patients with treatment
時間枠：Baseline, 6 months and 18 months
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compliance is measured with the questionnaire Girerd
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Baseline, 6 months and 18 months
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Pain
時間枠：Baseline, 6 months and 18 months
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Pain is measured with an ordinal scale from 0 to 10
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Baseline, 6 months and 18 months
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Proportion of potential inappropriate medication
時間枠：Baseline, 1 month, 6 months and 18 months
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The proportion of potential inappropriate medication will be measured on the drug prescribing of the patients issued from the referring physician
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Baseline, 1 month, 6 months and 18 months
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Problems associated with drug therapy
時間枠：Baseline, 1 month, 6 months and 18 months
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The proportion of problems associated with drug therapy will be measured on the drugs prescribing of the patients issued from the referring physician
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Baseline, 1 month, 6 months and 18 months
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acceptance rate by the referring physicians of pharmaceutical recommendation
時間枠：Baseline, 1 month, 6 months and 18 months
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The acceptance rate of the pharmaceutical review will be evaluated in 2 complementary ways:
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Baseline, 1 month, 6 months and 18 months
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協力者と研究者
スポンサー
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- 69HCL15-0104
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