Clinical trial NCT02379455: Cooperation for Improved Pharmacotherapy in Home-dwelling Elderly People Receiving Polypharmacy - The COOP Study
Official title: Cooperation for Improved Pharmacotherapy in Home-dwelling Elderly People Receiving Polypharmacy - The COOP Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Drug Usage
Keywords: Polypharmacy
Geriatrics
Elderly
Drug review
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: The Research Council of Norway
name: University of Oslo
First posted: 2015-03-05
Enrollment: 192
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Health-related quality of life as measured with 15D
timeFrame: 16 weeks
Secondary outcomes:
measure: Short Physical Performance Battery (SPPB)
timeFrame: 16 weeks
measure: Short Physical Performance Battery (SPPB)
timeFrame: 24 weeks
measure: Gait speed
timeFrame: 16 weeks
measure: Gait speed
timeFrame: 24 weeks
measure: Hand grip strength
timeFrame: 16 weeks
measure: Hand grip strength
timeFrame: 24 weeks
measure: Functional Independence Measure (FIM)
timeFrame: 16 weeks
measure: Functional Independence Measure (FIM)
timeFrame: 24 weeks
measure: Trail making test A and B
timeFrame: 16 weeks
measure: Trail making test A and B
timeFrame: 24 weeks
measure: Digit Span
timeFrame: 16 weeks
measure: Digit Span
timeFrame: 24 weeks
measure: Five Digits Test
timeFrame: 16 weeks
measure: Five Digits Test
timeFrame: 24 weeks
measure: Medication Appropriateness Index (MAI)
timeFrame: 16 weeks
measure: Medication Appropriateness Index (MAI)
timeFrame: 24 weeks
measure: Assessment of Underutilization (AOU)
timeFrame: 16 weeks
measure: Assessment of Underutilization (AOU)
timeFrame: 24 weeks
measure: Number of falls
timeFrame: During the first 16 weeks after baseline
measure: Number of falls
timeFrame: During the first 24 weeks after baseline
measure: Orthostatic blood pressure
timeFrame: 16 weeks
measure: Orthostatic blood pressure
timeFrame: 24 weeks
measure: Changes in body weight
timeFrame: 16 weeks
measure: Changes in body weight
timeFrame: 24 weeks
measure: Relative Stress Scale
timeFrame: 16 weeks
measure: Relative Stress Scale
timeFrame: 24 weeks
measure: Number of hospital admissions (with reasons)
timeFrame: During the first 16 weeks from baseline
measure: Number of hospital admissions (with reasons)
timeFrame: During the first 24 weeks from baseline
measure: Number of days in own home (in contrast to being in hospital or nursing home)
timeFrame: During the first 16 weeks from baseline
measure: Number of days in own home (in contrast to being in hospital or nursing home)
timeFrame: During the first 24 weeks from baseline
measure: Admission to permanent institutional care
timeFrame: 16 weeks
measure: Admission to permanent institutional care
timeFrame: 24 weeks
measure: Current use of home nursing service
timeFrame: 16 weeks
measure: Current use of home nursing service
timeFrame: 24 weeks
measure: Mortality
timeFrame: 16 weeks
measure: Mortality
timeFrame: 24 weeks
measure: Health-related quality of life as measured with 15D
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Dept. of Geriatric Medicine, Oslo University Hospital
Study officials:
affiliation: Oslo University Hospital
name: Torgeir B Wyller, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Veddeng S, Madland H, Molden E, Wyller TB, Romskaug R. Association between statin use and physical performance in home-dwelling older patients receiving polypharmacy: cross-sectional study. BMC Geriatr. 2022 Mar 23;22(1):242. doi: 10.1186/s12877-022-02942-7.
citation: Romskaug R, Skovlund E, Straand J, Molden E, Kersten H, Pitkala KH, Lundqvist C, Wyller TB. Effect of Clinical Geriatric Assessments and Collaborative Medication Reviews by Geriatrician and Family Physician for Improving Health-Related Quality of Life in Home-Dwelling Older Patients Receiving Polypharmacy: A Cluster Randomized Clinical Trial. JAMA Intern Med. 2020 Feb 1;180(2):181-189. doi: 10.1001/jamainternmed.2019.5096.
citation: Romskaug R, Molden E, Straand J, Kersten H, Skovlund E, Pitkala KH, Wyller TB. Cooperation between geriatricians and general practitioners for improved pharmacotherapy in home-dwelling elderly people receiving polypharmacy - the COOP Study: study protocol for a cluster randomised controlled trial. Trials. 2017 Apr 4;18(1):158. doi: 10.1186/s13063-017-1900-0.