Functional Autonomy LevelOPTIMNCT02740764
Optimization of Drug Prescribing in an Elderly Population of Geriatric Consultations
A study testing Optimization of drug prescribing in people with Functional Autonomy Level, run by Hospices Civils de Lyon at 2 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Functional Autonomy Level
- What is being tested?
- Optimization of drug prescribing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 302 participants
- Where
- 2 sitesFrance
- Study dates
- May 2016to Nov 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- Patients with no discernment;
- Patient put under legal protection;
Trial locations and contacts
2 sites in 1 country.
France2 sites, 2 recruiting
- Not yet recruiting
Hôpital gériatrique du Mont d'Or
Albigny-sur-Saône
Aurélia MARFISI - DUBOST, PH
Ahmed SALMI, PH
- Recruiting
Hôpital des Charpennes
Lyon
Pierre Krolak Salmon, PU PH
About this study
Official title: 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.
- Conditions
- Functional Autonomy Level
- Being tested
- Optimization of drug prescribing
- Keywords
- Functional autonomy level, Lawton Instrumental Activities of Daily Living, Cognitive disorders, Potentially inappropriate medication, elderly, Optimization of drug prescribing
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optimization of drug prescribingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Optimization of drug prescribing | Experimental | 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. Receives: Other: Optimization of drug prescribing |
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At 18 months
Secondary outcomes (20)
Number of Hospitalizations
the occurrence of hospitalizations within 18 months after baseline
Measured: Baseline, 1 month, 6 months and 18 months
Number of days before hospitalizations
delay between baseline and the hospitalization
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline, 1 month, 6 months and 18 months
Number of days before admission in institution
delay between baseline and the admission in institution
Measured: Baseline, 1 month, 6 months and 18 months
Death
the occurrence of death within 18 months after baseline
Measured: Baseline, 1 month, 6 months and 18 months
Number of days before death
delay between baseline and death
Measured: Baseline, 1 month, 6 months and 18 months
Falls
the occurrence of falls within 18 months after baseline
Measured: Baseline, 1 month, 6 months and 18 months
Number of days before falls
the delay between baseline and falls
Measured: 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.
Measured: Baseline, 6 months and 18 months
Quality of life 1
Quality of life measured by questionnaire QoL-AD
Measured: Baseline, 6 months and 18 months
Quality of life 2
Quality of life measured by questionnaire EUROQOL 5D
Measured: Baseline, 6 months and 18 months
depression disorders
depression measured with the mini-GDS scale
Measured: Baseline, 6 months and 18 months
Anxiety disorders
Anxiety disorders will be measured with the Hamilton scale
Measured: Baseline, 6 months and 18 months
Compliance of patients with treatment
compliance is measured with the questionnaire Girerd
Measured: Baseline, 6 months and 18 months
Pain
Pain is measured with an ordinal scale from 0 to 10
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline, 1 month, 6 months and 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2016 (estimated)
- Study startMay 2016
- Primary completionNov 2020 (estimated)
- Study completionNov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Functional Autonomy LevelStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 302 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02740764
- Sponsor's protocol ID
- 69HCL15-0104
- Acronym
- OPTIM
- Status last verified
- Aug 2018
- First submitted
- 6 Apr 2016
- Last updated
- 3 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 28854884
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimization of Drug Prescribing in an Elderly Population of Geriatric Consultations and Living at Home
- ClinicalTrials.gov ID
- NCT02740764
- Acronym / sponsor ID
- OPTIM / 69HCL15-0104
- Conditions
- Functional Autonomy Level
- Keywords
- Functional autonomy level, Lawton Instrumental Activities of Daily Living, Cognitive disorders, Potentially inappropriate medication, elderly, Optimization of drug prescribing
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 302 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- May 2016 (actual)
- Primary completion
- Nov 2020 (estimated)
- Study completion
- Nov 2020 (estimated)
- First posted
- 15 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Optimization of drug prescribing | Experimental | Other: Optimization of drug prescribingThe 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. |
| 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- 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);
Key exclusion criteria (2 listed)
- Patients with no discernment;
- Patient put under legal protection;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Optimization of drug prescribingThe 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. | Other | Optimization of drug prescribing |
Primary outcome
The evolution of the level of functional autonomy of the patients assessed using the scale IADL of Lawton
Time frame: At inclusion
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.
The evolution of the level of functional autonomy of the patients assessed using the scale IADL of Lawton
Time frame: At 1 month
The primary outcome will be calculated using the 4 successive evaluations of IADL scale.
The evolution of the level of functional autonomy of the patients assessed using the scale IADL of Lawton
Time frame: At 6 months
The primary outcome will be calculated using the 4 successive evaluations of IADL scale.
The evolution of the level of functional autonomy of the patients assessed using the scale IADL of Lawton
Time frame: At 18 months
The primary outcome will be calculated using the 4 successive evaluations of IADL scale.
The evolution of the level of functional autonomy of the patients assessed using the scale DAD-6.
Time frame: At inclusion
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 DAD-6.
Time frame: At 1 month
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 DAD-6.
Time frame: At 6 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 DAD-6.
Time frame: 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.
20 secondary outcomes
Number of Hospitalizations
Time frame: Baseline, 1 month, 6 months and 18 months
Number of days before hospitalizations
Time frame: Baseline, 1 month, 6 months and 18 months
Occurrence of recourse to emergency service
Time frame: Baseline, 1 month, 6 months and 18 months
Number of days before the recourse to emergency service
Time frame: Baseline, 1 month, 6 months and 18 months
The occurrence of admission in institution
Time frame: Baseline, 1 month, 6 months and 18 months
Number of days before admission in institution
Time frame: Baseline, 1 month, 6 months and 18 months
Death
Time frame: Baseline, 1 month, 6 months and 18 months
Number of days before death
Time frame: Baseline, 1 month, 6 months and 18 months
Falls
Time frame: Baseline, 1 month, 6 months and 18 months
Number of days before falls
Time frame: Baseline, 1 month, 6 months and 18 months
Cognitive functions
Time frame: Baseline, 6 months and 18 months
Quality of life 1
Time frame: Baseline, 6 months and 18 months
Quality of life 2
Time frame: Baseline, 6 months and 18 months
depression disorders
Time frame: Baseline, 6 months and 18 months
Anxiety disorders
Time frame: Baseline, 6 months and 18 months
Compliance of patients with treatment
Time frame: Baseline, 6 months and 18 months
Pain
Time frame: Baseline, 6 months and 18 months
Proportion of potential inappropriate medication
Time frame: Baseline, 1 month, 6 months and 18 months
Problems associated with drug therapy
Time frame: Baseline, 1 month, 6 months and 18 months
acceptance rate by the referring physicians of pharmaceutical recommendation
Time frame: Baseline, 1 month, 6 months and 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2018.
- Derived from this study: PubMed 28854884Dauphinot 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Optimization of drug prescribing in people with Functional Autonomy Level, run by Hospices Civils de Lyon at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dauphinot Virginie, Dr (33 (0)4 72 43 20 50, virginie.dauphinot@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The evolution of the level of functional autonomy of the patients assessed using the scale IADL of Lawton (time frame: At inclusion). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02740764, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2018.