Cooperation for Improved Pharmacotherapy in Home-dwelling Elderly People Receiving Polypharmacy - The COOP Study

Study Overview
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Brief Summary
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Polypharmacy increases the risk of adverse drug effects, interactions and other drug-related problems, and several studies indicate that inappropriate drug use is a major reason for poor health and impaired function in the elderly. A majority of interventions for improvement of drug treatment in the elderly have been evaluated by the use of surrogate outcomes such as drug-related problems, number of prescribed drugs or prevalence of potentially inappropriate prescriptions - and it is so far unclear whether such interventions can result in clinical significant improvements. The primary objective of this trial is therefore to evaluate the effect upon patients, relatives and local health care service of a structured cooperation between a hospital-based geriatrician and family physicians on complex drug regimens in home-dwelling frail elderly patients.

Detailed Description
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This is a 24 weeks cluster randomized, single-blinded, controlled trial. Family physicians will be invited to participate in the project with patients from their lists, and can participate with 1-5 patients each. The investigators will carry out cluster randomization on physician level instead of individual randomization on patient level. The investigators suppose that such a comprehensive clinical evaluation and drug review that they will test, is most relevant for patients with relatively pronounced polypharmacy. It has previously been shown that conventionally used limits for polypharmacy, e.g. five drugs used regularly, identifies many patients without particular complex health states and without drug related problems. The investigators will therefore limit this project to patients using seven regular drugs or more, in order to increase the likelihood that they may benefit from a drug review. A major challenge when studying complex interventions is to describe the intervention with sufficient precision as to facilitate replication. Our main strategy for this will be to compensate for the necessary degree of pragmatism in the interventional approach with a detailed description of the interventions that were in fact carried out, in particular changes in the drug regimens of the individual patients. The intervention will consist of three main parts: Geriatric assessment: The patients will be seen by a physician trained in geriatric medicine. The physician will carry out a medical history and a physical examination, and relevant blood analyses and other supplementary test will be ordered if not already available. The geriatric work-up will be aimed at evaluating whether current medications are indicated, whether the relevant conditions are satisfactorily compensated, whether the dosages are appropriate, whether the patient has symptoms that may in reality be adverse drug effects, and whether drug-drug interactions or drug-disease interactions are likely to occur. Published tools like the START (Screening Tool of Older Persons' Prescriptions) criteria, Screening Tool to Alert doctors to Right Treatment (STOPP) criteria and The Norwegian General Practice (NORGEP) criteria will be used. Conference with common drug review: The main purpose of this conference is to combine the competence of the geriatrician and that of the family physician in a focused drug review. The two physicians will discuss the patient's drug list systematically. The geriatrician may suggest changes in the drug regimen, but the family physician retains the medical responsibility for the patient and is in charge of all ordinations and medication changes. Clinical follow-up: Depending on medication changes that have been done, the two physicians will arrange the necessary follow-up within the project period. The investigators will assess the outcomes at 16 and 24 weeks, counted from baseline, and will also assess baseline values for the outcomes in order to adjust for potential inequalities.

Official Title
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Cooperation for Improved Pharmacotherapy in Home-dwelling Elderly People Receiving Polypharmacy - The COOP Study

Conditions
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Drug Usage

Intervention / Treatment
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* Other: Comprehensive drug review


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The patient must be on the list of one of the family physicians participating in the study Home dwelling (not permanently institutionalised) Medications administered by the home nursing service Polypharmacy defined as the use of at least seven different systemic medications taken regularly Informed consent by the patient or a close relative Exclusion Criteria: Patient or relative denies inclusion The family physician does not want the particular patient to participate Moderate/severe dementia (Clinical Dementia Rating Scale score > 1) and contact with the closest proxy less than once every other week. The patient does not speak/understand Norwegian Expected to become permanently institutionalised within six months Life expectancy < six months

Ages Eligible for Study
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Minimum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Comprehensive drug review<br> | Other: Comprehensive drug review<br>* 1) Geriatric assessment including medical history, physical examination, supplementary tests. The geriatric work-up will be aimed at evaluating whether current medications are indicated, whether the relevant conditions are satisfactorily compensated, whether the dosages are appropriate, whether the patient has symptoms that may in reality be adverse drug effects, and whether drug-drug interactions or drug-disease interactions are likely to occur. 2) Conference with common drug review. The project physician and the family physician will discuss the patient's drug list systematically. 3) Individualized clinical follow-up depending on the medication changes that have been done.<br>|
| No Intervention: Control group<br>Follow-up by family physician as usual. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health-related quality of life as measured with 15D |  | 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Short Physical Performance Battery (SPPB) |  | 16 weeks | 
| Short Physical Performance Battery (SPPB) |  | 24 weeks | 
| Gait speed |  | 16 weeks | 
| Gait speed |  | 24 weeks | 
| Hand grip strength |  | 16 weeks | 
| Hand grip strength |  | 24 weeks | 
| Functional Independence Measure (FIM) |  | 16 weeks | 
| Functional Independence Measure (FIM) |  | 24 weeks | 
| Trail making test A and B |  | 16 weeks | 
| Trail making test A and B |  | 24 weeks | 
| Digit Span |  | 16 weeks | 
| Digit Span |  | 24 weeks | 
| Five Digits Test |  | 16 weeks | 
| Five Digits Test |  | 24 weeks | 
| Medication Appropriateness Index (MAI) |  | 16 weeks | 
| Medication Appropriateness Index (MAI) |  | 24 weeks | 
| Assessment of Underutilization (AOU) |  | 16 weeks | 
| Assessment of Underutilization (AOU) |  | 24 weeks | 
| Number of falls | Recorded with the aid of diaries kept by patients/caregivers | During the first 16 weeks after baseline | 
| Number of falls | Recorded with the aid of diaries kept by patients/caregivers | During the first 24 weeks after baseline | 
| Orthostatic blood pressure |  | 16 weeks | 
| Orthostatic blood pressure |  | 24 weeks | 
| Changes in body weight |  | 16 weeks | 
| Changes in body weight |  | 24 weeks | 
| Relative Stress Scale |  | 16 weeks | 
| Relative Stress Scale |  | 24 weeks | 
| Number of hospital admissions (with reasons) |  | During the first 16 weeks from baseline | 
| Number of hospital admissions (with reasons) |  | During the first 24 weeks from baseline | 
| Number of days in own home (in contrast to being in hospital or nursing home) |  | During the first 16 weeks from baseline | 
| Number of days in own home (in contrast to being in hospital or nursing home) |  | During the first 24 weeks from baseline | 
| Admission to permanent institutional care |  | 16 weeks | 
| Admission to permanent institutional care |  | 24 weeks | 
| Current use of home nursing service |  | 16 weeks | 
| Current use of home nursing service |  | 24 weeks | 
| Mortality |  | 16 weeks | 
| Mortality |  | 24 weeks | 
| Health-related quality of life as measured with 15D |  | 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Polypharmacy, Geriatrics, Elderly, Drug review