Cooperation for Improved Pharmacotherapy in Home-dwelling Elderly People Receiving Polypharmacy - The COOP Study
- Conditions
- Drug Usage
- Interventions
- Other: Comprehensive drug review
- Registration Number
- NCT02379455
- Lead Sponsor
- Oslo University Hospital
- Brief Summary
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
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:
1. 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.
2. 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.
3. 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 192
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Comprehensive drug review Comprehensive drug review -
- Primary Outcome Measures
Name Time Method Health-related quality of life as measured with 15D 16 weeks
- Secondary Outcome Measures
Name Time Method Assessment of Underutilization (AOU) 24 weeks Trail making test A and B 24 weeks Five Digits Test 24 weeks Relative Stress Scale 24 weeks Mortality 24 weeks Short Physical Performance Battery (SPPB) 24 weeks Gait speed 24 weeks Digit Span 24 weeks Hand grip strength 24 weeks Functional Independence Measure (FIM) 24 weeks Medication Appropriateness Index (MAI) 24 weeks Orthostatic blood pressure 24 weeks Number of hospital admissions (with reasons) During the first 24 weeks from baseline Current use of home nursing service 24 weeks Number of falls During the first 24 weeks after baseline Recorded with the aid of diaries kept by patients/caregivers
Changes in body weight 24 weeks Health-related quality of life as measured with 15D 24 weeks 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 24 weeks
Trial Locations
- Locations (1)
Dept. of Geriatric Medicine, Oslo University Hospital
🇳🇴Oslo, Norway