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

Abstract Background Polypharmacy and inappropriate drug use is associated with negative health outcomes among older people. Various interventions for improving drug treatment have been evaluated, but the majority of studies are limited by the use of surrogate outcomes or suboptimal design. Thus, the...

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Main Authors: Rita Romskaug, Espen Molden, Jørund Straand, Hege Kersten, Eva Skovlund, Kaisu H Pitkala, Torgeir Bruun Wyller
Format: Article
Language:English
Published: BMC 2017-04-01
Series:Trials
Subjects:
Online Access:http://link.springer.com/article/10.1186/s13063-017-1900-0
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author Rita Romskaug
Espen Molden
Jørund Straand
Hege Kersten
Eva Skovlund
Kaisu H Pitkala
Torgeir Bruun Wyller
author_facet Rita Romskaug
Espen Molden
Jørund Straand
Hege Kersten
Eva Skovlund
Kaisu H Pitkala
Torgeir Bruun Wyller
author_sort Rita Romskaug
collection DOAJ
description Abstract Background Polypharmacy and inappropriate drug use is associated with negative health outcomes among older people. Various interventions for improving drug treatment have been evaluated, but the majority of studies are limited by the use of surrogate outcomes or suboptimal design. Thus, the potential for clinically significant improvements from different interventions is still unclear. The main objective of this study is therefore to evaluate the effect upon patient-relevant endpoints of a cooperation between geriatricians and general practitioners on complex drug regimens in home-dwelling elderly people. Methods This is a cluster randomised, single-blind, controlled trial where general practitioners are invited to participate with patients from their lists. The patients must be 70 years or older, use at least seven different medications and have their medications administered by the home nursing service. We plan to recruit 200 patients, with randomisation at physician level. The intervention consists of three main parts: (1) clinical geriatric assessment of the patient, combined with a thorough review of their medications; (2) a meeting between the geriatrician and general practitioner, where the two physicians combine their competence and knowledge and discuss the drug list systematically; (3) clinical follow-up, depending on the medication changes that have been done. The study period is 24 weeks, and the patients are assessed at baseline, 16 and 24 weeks. The primary outcome measure is health-related quality of life according to the 15D instrument. Secondary outcome measures include physical and cognitive functioning, medication appropriateness, falls, carer burden, use of health services (hospital or nursing home admissions, use of home nursing services) and mortality. Discussion Our choice of patient-relevant outcome measures will hopefully provide new knowledge on the potential for clinical improvements after performing comprehensive medication reviews in home-dwelling elderly people receiving polypharmacy. Trial registration ClinicalTrials.gov, NCT02379455 . Registered on 27 February 2015.
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spelling doaj.art-b1be3a6f7f094430bd674143316681ae2022-12-21T19:01:27ZengBMCTrials1745-62152017-04-011811910.1186/s13063-017-1900-0Cooperation 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 trialRita Romskaug0Espen Molden1Jørund Straand2Hege Kersten3Eva Skovlund4Kaisu H Pitkala5Torgeir Bruun Wyller6Department of Geriatric medicine, Institute of Clinical Medicine, University of OsloSchool of Pharmacy, University of OsloDepartment of General Practice, Institute of Health and Society, University of OsloSchool of Pharmacy, University of OsloDepartment of Public Health and General Practice, NTNUDepartment of General Practice, University of HelsinkiDepartment of Geriatric medicine, Institute of Clinical Medicine, University of OsloAbstract Background Polypharmacy and inappropriate drug use is associated with negative health outcomes among older people. Various interventions for improving drug treatment have been evaluated, but the majority of studies are limited by the use of surrogate outcomes or suboptimal design. Thus, the potential for clinically significant improvements from different interventions is still unclear. The main objective of this study is therefore to evaluate the effect upon patient-relevant endpoints of a cooperation between geriatricians and general practitioners on complex drug regimens in home-dwelling elderly people. Methods This is a cluster randomised, single-blind, controlled trial where general practitioners are invited to participate with patients from their lists. The patients must be 70 years or older, use at least seven different medications and have their medications administered by the home nursing service. We plan to recruit 200 patients, with randomisation at physician level. The intervention consists of three main parts: (1) clinical geriatric assessment of the patient, combined with a thorough review of their medications; (2) a meeting between the geriatrician and general practitioner, where the two physicians combine their competence and knowledge and discuss the drug list systematically; (3) clinical follow-up, depending on the medication changes that have been done. The study period is 24 weeks, and the patients are assessed at baseline, 16 and 24 weeks. The primary outcome measure is health-related quality of life according to the 15D instrument. Secondary outcome measures include physical and cognitive functioning, medication appropriateness, falls, carer burden, use of health services (hospital or nursing home admissions, use of home nursing services) and mortality. Discussion Our choice of patient-relevant outcome measures will hopefully provide new knowledge on the potential for clinical improvements after performing comprehensive medication reviews in home-dwelling elderly people receiving polypharmacy. Trial registration ClinicalTrials.gov, NCT02379455 . Registered on 27 February 2015.http://link.springer.com/article/10.1186/s13063-017-1900-0PolypharmacyInappropriate drug useMedication reviewGeriatricsElderlyHome-dwelling
spellingShingle Rita Romskaug
Espen Molden
Jørund Straand
Hege Kersten
Eva Skovlund
Kaisu H Pitkala
Torgeir Bruun Wyller
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
Polypharmacy
Inappropriate drug use
Medication review
Geriatrics
Elderly
Home-dwelling
title 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
title_full 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
title_fullStr 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
title_full_unstemmed 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
title_short 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
title_sort 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
topic Polypharmacy
Inappropriate drug use
Medication review
Geriatrics
Elderly
Home-dwelling
url http://link.springer.com/article/10.1186/s13063-017-1900-0
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