Cooperation for Improved Pharmacotherapy in Home-dwelling Elderly People Receiving Polypharmacy - The COOP Study
COOP
1 other identifier
interventional
192
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2015
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 27, 2015
CompletedStudy Start
First participant enrolled
March 1, 2015
CompletedFirst Posted
Study publicly available on registry
March 5, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
September 22, 2017
CompletedJanuary 26, 2018
January 1, 2018
2.4 years
February 27, 2015
January 24, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Health-related quality of life as measured with 15D
16 weeks
Secondary Outcomes (37)
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
- +32 more secondary outcomes
Study Arms (2)
Comprehensive drug review
EXPERIMENTALControl group
NO INTERVENTIONFollow-up by family physician "as usual".
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Oslo University Hospitallead
- The Research Council of Norwaycollaborator
- University of Oslocollaborator
Study Sites (1)
Dept. of Geriatric Medicine, Oslo University Hospital
Oslo, 0424, Norway
Related Publications (3)
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.
PMID: 35321652DERIVEDRomskaug 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.
PMID: 31617562DERIVEDRomskaug 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.
PMID: 28372591DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Torgeir B Wyller, MD PhD
Oslo University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD
Study Record Dates
First Submitted
February 27, 2015
First Posted
March 5, 2015
Study Start
March 1, 2015
Primary Completion
August 1, 2017
Study Completion
September 22, 2017
Last Updated
January 26, 2018
Record last verified: 2018-01