Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
450 participants
INTERVENTIONAL
2024-09-10
2025-12-01
Brief Summary
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To investigate the effect of training health care professionals in medication assessments on the medication use of nursing home residents with a limited life expectancy (\< 1.5-2 years).
The core of the training is to tailor medication use to (palliative) treatment goals of nursing home residents.
Design:
A cluster randomized controlled trial on long term care wards in nursing homes, with the nursing home care organisations as unit of randomisation. The investigators intent to include 6 organisations and 450 nursing home patients. The research starts in september and lasts 1 year and 3 months. Eligible patients are nursing home patients of 65 years and older with a limited life expectancy (\< 1.5-2 year) of long term care wards.
Intervention:
The intervention includes a method in which healthcare professionals (medical practitioner, pharmacist and care worker) are trained to tailor medication to the (palliative) treatment goals of nursing home patients with a limited life expectancy. The training consists of 2 components: 1) medication assessment, and 2) advance care planning (ACP). In the intervention group, healthcare professionals receive the training in combination with supporting tools and educational materials, in the control group care continues as normal. The allocation ratio for control and intervention groups is 1:1. A process evaluation will take place simultaneously with the intervention study. Data collection takes place before the start of the intervention (T0), after 6 months (T1) and after 12 months (T2).
Outcome measures:
The primary outcome measure is potential under- and over-treatment with medication. The secondary outcome measure is experienced involvement in decision-making (measured with a short questionnaire based on the revised PATD (patients' attitude towards deprescribing)). Tertiary outcome measures are: quality of life, deaths, falls, hospital admissions/acute first aid referrals and pain.
Discussion:
The intervention is expected to result in a decrease in chronic and preventive medication prescriptions, an increase in medication for symptom treatment and more involvement (and satisfaction) of the nursing home resident in decision-making, without adverse effects.
Detailed Description
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We included 2 nursinghome organizations in september, 2 in october, and 3 in november.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Control
Control group, care as usual
No interventions assigned to this group
Educational intervention
The clusters that fall into the experimental arm receive the educational intervention: they receive an in-house training in combination with supporting tools, educational materials and intervision moments.
Systematic multidisciplinary medication review + ACP (SMMR+)
The intervention is a training in medication assessment. The goal is to align prescription with the treatment goals of nursing home patients which are set in advance care planning conversations. The training consists of 2 components:
1. Medication assessment with the use of the ReNeWAL criteria (adjusted STOPP/START criteria, tailored to nursing home patients with a limited life expectancy)
2. Advance care planning component. Discussing medication in line with the treatment goals set in advance care planning conversations.
Healthcare professionals receive the training in combination with supporting tools (pocket card) and educational material (the ReNeWAL criteria and PowerPoint slides of the training if requested). Also, intervision moments are planned.
Interventions
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Systematic multidisciplinary medication review + ACP (SMMR+)
The intervention is a training in medication assessment. The goal is to align prescription with the treatment goals of nursing home patients which are set in advance care planning conversations. The training consists of 2 components:
1. Medication assessment with the use of the ReNeWAL criteria (adjusted STOPP/START criteria, tailored to nursing home patients with a limited life expectancy)
2. Advance care planning component. Discussing medication in line with the treatment goals set in advance care planning conversations.
Healthcare professionals receive the training in combination with supporting tools (pocket card) and educational material (the ReNeWAL criteria and PowerPoint slides of the training if requested). Also, intervision moments are planned.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age 65years and above
* Living at long term care wards in nursing homes
* Living at a long term care ward for at least 4 weeks before start of the study
Exclusion Criteria
* Life expectancy \< 4 weeks
* Life expectancy clearly \> 1.5 - 2 years (i.e. patients with Huntingtons disease)
65 Years
ALL
No
Sponsors
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ZonMw: The Netherlands Organisation for Health Research and Development
OTHER
Amsterdam UMC, location VUmc
OTHER
Responsible Party
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Martin Smalbrugge
Principal investigator, professor of Medicine for Older People and chair of the Department of Medicine for Older People
Principal Investigators
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Martin Smalbrugge, Prof
Role: STUDY_DIRECTOR
Amsterdam UMC, location VUmc, departement Medicine for Older People
Locations
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Zorggroep Apeldoorn, location Randerode, De Hofstede and De Windkanter
Apeldoorn, Gelderland, Netherlands
Zorggroep Noordwest-Veluwe, locaties Weideheem en de Arcade
Harderwijk, Gelderland, Netherlands
Cordaan, location Nieuw Vredenburgh
Amsterdam, North Holland, Netherlands
Amaris, Location Alporti and Rubina
Hilversum, North Holland, Netherlands
AxionContinu, location Isselwaerde and de Schutse
IJsselstein, Utrecht, Netherlands
Zorgspectrum, location de Plataan
Vianen, Utrecht, Netherlands
Dignis, location de Veldspaat
Groningen, , Netherlands
Countries
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Central Contacts
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Facility Contacts
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Role: primary
Role: primary
Role: primary
Other Identifiers
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839160003
Identifier Type: -
Identifier Source: org_study_id