NCT06731361 Improved Prescribing for Older Nursing Home Patients
| NCT ID | NCT06731361 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Amsterdam UMC, location VUmc |
| Condition | Nursing Home Residents |
| Study Type | INTERVENTIONAL |
| Enrollment | 450 participants |
| Start Date | 2024-09-10 |
| Primary Completion | 2025-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 450 participants in total. It began in 2024-09-10 with a primary completion date of 2025-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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)
Contact & Investigator
Martin Smalbrugge, Prof
STUDY DIRECTOR
Amsterdam UMC, location VUmc, departement Medicine for Older People
Frequently Asked Questions
Who can join the NCT06731361 clinical trial?
This trial is open to participants of all sexes, aged 65 Years or older, studying Nursing Home Residents. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06731361 currently recruiting?
Yes, NCT06731361 is actively recruiting participants. Contact the research team at m.dijk5@amsterdamumc.nl for enrollment information.
Where is the NCT06731361 trial being conducted?
This trial is being conducted at Apeldoorn, Netherlands, Harderwijk, Netherlands, Amsterdam, Netherlands, Hilversum, Netherlands and 3 additional locations.
Who is sponsoring the NCT06731361 clinical trial?
NCT06731361 is sponsored by Amsterdam UMC, location VUmc. The principal investigator is Martin Smalbrugge, Prof at Amsterdam UMC, location VUmc, departement Medicine for Older People. The trial plans to enroll 450 participants.