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Recruiting NCT06731361

Improved Prescribing for Older Nursing Home Patients

No phase Interventional Nursing Home Residents Older People Prescribing Advance Care Planning

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Systematic multidisciplinary medication review + ACP (SMMR+).
Who it may be relevant to
Registry conditions: Nursing Home Residents, Older People, Prescribing, Advance Care Planning. Basic parameters: from 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Netherlands
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Improving Medication Prescription in the contExt of Advance Care Planning for paTients Receiving Long Term nUrSing Home Care

Overview

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.

Detailed description

Additional information on the method:

We included 2 nursinghome organizations in september, 2 in october, and 3 in november.

Interventions

  • Combination product 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

Primary outcome measures

  • Potential under- and overprescribing [Time frame: at baseline - 6 months - 12 months]
Secondary outcome measures (1)
  • Experienced involvement in decision-making [Time frame: At baseline and 2-4 weeks after the medication review]

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

Netherlands · 7 centers
  • Zorggroep Apeldoorn, location Randerode, De Hofstede and De Windkanter — Apeldoorn
  • Zorggroep Noordwest-Veluwe, locaties Weideheem en de Arcade — Harderwijk
  • Cordaan, location Nieuw Vredenburgh — Amsterdam
  • Amaris, Location Alporti and Rubina — Hilversum
  • AxionContinu, location Isselwaerde and de Schutse — IJsselstein
  • Zorgspectrum, location de Plataan — Vianen
  • Dignis, location de Veldspaat — Groningen

Identifiers

NCT: NCT06731361 · 839160003

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗