Clinical Trials in the Netherlands / NCT06731361
Recruiting Not applicable

Improved Prescribing for Older Nursing Home Patients

NCT06731361 · tracked via the Priya Life Science Netherlands tracker
Phase
Not applicable
Started
2024-09-10
Last updated
2024-12-12

Condition(s) studied

Nursing Home ResidentsOlder PeoplePrescribingAdvance Care PlanningMedication ReviewsDecision MakingPrescribing Practices

Investigational drug(s) / intervention(s)

Systematic multidisciplinary medication review + ACP (SMMR+)

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.

Study summary

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.

Eligibility

Sex
ALL
Min age
65 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: Nursing home patients: * 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: * Temporary nursing home patients (i.e. geriatric rehabilitation or end-of-life/hospice care) * Life expectancy \< 4 weeks * Life expectancy clearly \> 1.5 - 2 years (i.e. patients with Huntingtons disease)

Primary outcome measure(s)

Trial sites (7)

FacilityCityRegionStatus
Zorggroep Apeldoorn, location Randerode, De Hofstede and De Windkanter Apeldoorn Gelderland Active Not Recruiting
Zorggroep Noordwest-Veluwe, locaties Weideheem en de Arcade Harderwijk Gelderland Active Not Recruiting
Cordaan, location Nieuw Vredenburgh Amsterdam North Holland Recruiting
Amaris, Location Alporti and Rubina Hilversum North Holland Active Not Recruiting
AxionContinu, location Isselwaerde and de Schutse IJsselstein Utrecht Recruiting
Zorgspectrum, location de Plataan Vianen Utrecht Recruiting
Dignis, location de Veldspaat Groningen Netherlands Active Not Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06731361 on ClinicalTrials.gov ↗ ← All trials in the Netherlands