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| Name | Class |
|---|---|
| ZonMw: The Netherlands Organisation for Health Research and Development | OTHER |
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Research aim:
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.
Additional information on the method:
We included 2 nursinghome organizations in september, 2 in october, and 3 in november.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | Control group, care as usual | |
| Educational intervention | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Systematic multidisciplinary medication review + ACP (SMMR+) | Combination Product | 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:
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. |
| Measure | Description | Time Frame |
|---|---|---|
| Potential under- and overprescribing | Potential under- and overprescribing | at baseline - 6 months - 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Experienced involvement in decision-making | Experienced involvement in decision-making measured with a questionnaire | At baseline and 2-4 weeks after the medication review |
| Measure | Description | Time Frame |
|---|---|---|
| QOL (Quality of life) | Quality of life measured with the EuroQol questionnaire (EQ-5D) | at baseline - 6 months - 12 months |
| Social wellbeing | Measured with Revised index for social engagement (RISE) questionnaire |
Inclusion Criteria:
Nursing home patients:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marlies Dijk, MD | Contact | 020-4445785 | 0031 | m.dijk5@amsterdamumc.nl |
| Eefje Sizoo, MD, PhD | Contact | 020-4445785 | 0031 | e.sizoo@amsterdamumc.nl |
| Name | Affiliation | Role |
|---|---|---|
| Martin Smalbrugge, Prof | Amsterdam UMC, location VUmc, departement Medicine for Older People | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zorggroep Apeldoorn, location Randerode, De Hofstede and De Windkanter | Active, not recruiting | Apeldoorn | Gelderland | 7334DV | Netherlands |
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Cluster randomised controlled trial with 2 arms: intervention and control. Ratio 1:1. 2 clusters start in september, 2 clusters start in october and 2 clusters start in november.
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| at baseline - 6 months - 12 months |
| Adverse outcomes | Adverse outcomes, such as: deaths, falls, hospital admissions/acute referrals, measured over the previous 6 months. (Only for ' deaths' not possible at baseline.) | at baseline - 6 months - 12 months |
| Pain assessment | measured with the pain items of the Resident Assessment Instrument for Long-term Care Facilities (RAI-LTCF) questionnaire | at baseline - 6 months - 12 months |
| Process evaluation | Qualitative and quantitative data | Through 1 year and 3 months |
| Zorggroep Noordwest-Veluwe, locaties Weideheem en de Arcade | Active, not recruiting | Harderwijk | Gelderland | 3844 JW | Netherlands |
| Cordaan, location Nieuw Vredenburgh | Recruiting | Amsterdam | North Holland | 1057 DZ | Netherlands |
|
| Amaris, Location Alporti and Rubina | Active, not recruiting | Hilversum | North Holland | 1215 SE | Netherlands |
| AxionContinu, location Isselwaerde and de Schutse | Recruiting | IJsselstein | Utrecht | 3401 BN | Netherlands |
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| Zorgspectrum, location de Plataan | Recruiting | Vianen | Utrecht | 4133 GX | Netherlands |
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| Dignis, location de Veldspaat | Active, not recruiting | Groningen | 9743XV | Netherlands |