Cooperation for Better Treatment of Polypharmacy in the Community

Study Overview
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Brief Summary
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The elderly population today relies heavily on medication consumption. While there are cases where using multiple medications is necessary and reasonable, it also increases the risk of inappropriate treatment and adverse drug effects. This randomized, controlled trial aims to examine the effectiveness of incorporating drug reviews as an integral part of clinical practice for older patients admitted to a Municipal Acute Bed Unit in Oslo, Norway. In Norwegian, such units are called Kommunale Akutte Døgnenheter (KAD). The intervention involves a clinical drug review conducted by a KAD physician under the guidance of a geriatrician, followed by a telephone consultation between the KAD physician and the patient's family physician (FP). The primary outcome measure is health-related quality of life, while secondary outcome measures include physical and cognitive function, dry mouth, hospital admissions, and survival. The environmental impact of the study intervention will also be assessed and compared to usual care.

Detailed Description
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The aim of this study is to evaluate the effect of collaborative drug reviews by KAD physicians, supervised by geriatricians, and FPs on clinically relevant outcome measures in the KAD patient population aged 70+. The investigators will also assess the environmental impact of the study intervention and compare it to usual care. The study is a randomized, single-blind, controlled trial with 16 weeks follow-up and acquisition of registry data for one year. The investigators will recruit 1-4 KAD physicians to take part in the study. The project physicians will be responsible for the patient's general medical treatment, but will also perform a structured, clinical drug review that goes beyond what is considered usual care. The project physicians will provide necessary information on the patient's medical history and drug use from the medical records, carry out a medical history from the patient, and a physical examination. Relevant blood analyses and other supplementary tests will be ordered if not already available. The clinical drug review will be aimed at evaluating whether current medications are indicated, whether the patient's medical conditions are satisfactorily compensated, whether dosages are appropriate, whether the patient has adverse drug effects, and whether drug-drug or drug-disease interactions are present or likely to occur. The investigators will develop a structured framework for the drug reviews, and the KAD physicians will receive clinical supervision from a consultant in geriatric medicine. After performing the clinical drug review, the KAD physician will offer the patient's FP a telephone based or digital meeting with the purpose of combining the assessments of the KAD physician and the competence of the FP in a common drug review. The two physicians will review the patient's drug list systematically and discuss if any adjustments should be done, as well as the patient's need for further follow-up.

Official Title
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The COOP II Study: Cooperation for Better Treatment of Polypharmacy in the Community. A Randomized, Controlled Trial

Conditions
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Drug Usage

Intervention / Treatment
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* Other: Collaborative drug review


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 70+ Admitted to KAD Use of at least six different systemic medications taken regularly Informed consent by the patient Exclusion Criteria: Previously included in the study Not speaking or understanding Norwegian Residing outside of the municipality of Oslo Planned discharge within 24 hours Isolated for infection control reasons Considered too ill to approach or life expectancy judged to be less than six months Personnel at KAD discourage participation (in case of important reasons not covered by the other exclusion criteria)

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: Intervention group<br>Collaborative drug review. | Other: Collaborative drug review<br>* Structured, clinical drug review including medical history, physical examination, and supplementary tests. The work-up will be aimed at evaluating whether current medications are indicated, whether the patient's medical conditions are satisfactorily compensated, whether dosages are appropriate, whether the patient has adverse drug effects, and whether drug-drug or drug-disease interactions are present or likely to occur. The KAD physicians will receive clinical supervision from a consultant in geriatric medicine. The KAD physician will offer the patient's FP a telephone meeting with the purpose of combining the assessments of the KAD physician and the competence of the FP in a common drug review. The two physicians will review the patient's drug list systematically and discuss if any adjustments should be done, as well as the patient's need for further follow-up.<br>|
| No Intervention: Control group<br>Usual care. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health-related quality of life (HRQoL) | HRQoL assessed with the 15-dimensional instrument 15D. 15D is a generic, 15-dimensional instrument concerning different aspects of HRQoL. The dimensions are mobility, vision, hearing, breathing, sleeping, eating, speech, elimination, usual activities, mental function, discomfort and symptoms, depression, distress, vitality, and sexual activity. Each dimension is rated on an ordinal scale with five levels, and the respondent chooses the level best describing his/her present health status. Single index scores are calculated by population-based utility weights, and range from 0 to 1, with higher scores indicating better HRQoL. | 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of drugs in use | The number of drugs in use at baseline and at week 16 will be reported. | 16 weeks | 
| Number of new drugs started | The number of new drugs started in the period from baseline to week 16 will be reported. | 16 weeks | 
| Number of drug withdrawals | The number of drug withdrawals in the period from baseline to week 16 will be reported. | 16 weeks | 
| Number of drugs with increased dosages | The number of drugs with increased dosages when comparing baseline to week 16 will be reported. | 16 weeks | 
| Number of drugs with reduced dosages | The number of drugs with reduced dosages when comparing baseline to week 16 will be reported. | 16 weeks | 
| Handgrip strength | Handgrip strength measured with a standard dynamometer, with three attempts on each hand. The highest value of all six attempts will be reported, measured in kilograms. | 16 weeks | 
| Digit span forward | Results will be reported as the maximum digit span completed. | 16 weeks | 
| Digit span backwards | Results will be reported as the maximum digit span completed. | 16 weeks | 
| Unstimulated whole saliva flow | Unstimulated whole saliva flow will be measured by the spitting method by weighing plastic cups before and after a collection period of 3 minutes. Results will be reported as milliliters/minute. | 16 weeks | 
| The Shortened Xerostomia Inventory (SXI) | The Shortened Xerostomia Inventory (SXI) is a five-item summated rating scale which combines the responses to five individual items into a single sum score. The sum score can range from 5 to 15, with higher values representing more severe xerostomia. | 16 weeks | 
| The eight-item Visual Analog Scale xerostomia questionnaire | This is a Visual Analog Scale with eight questions related to xerostomia where participants will be asked to mark their response to each item by placing a vertical line on the 100 millimeter horizontal scale. Results will be reported as millimeters. | 16 weeks | 
| Orthostatic blood pressure | Supine blood pressure and pulse rate will be measured after a minimum of five minutes of rest. The patient will then stand up, and measurements will be repeated after one and three minutes. Orthostatic hypotension will be defined as a fall in systolic blood pressure of at least 20 mmHg or a fall in diastolic blood pressure of at least 10 mmHg after one and/or three minutes in standing position. | 16 weeks | 
| Falls | Number of falls. | 16 weeks | 
| Admissions to health institutions | The number of hospital admissions, nursing home admissions, and KAD readmissions in the period from baseline to week 16, as well as in the period from baseline to one year. | 16 weeks and 1 year | 
| Mortality | Mortality in the period from baseline to week 16, as in the period from baseline to one year. | 16 weeks and 1 year | 

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