An interventional study of Systematic multidisciplinary medication review + ACP (SMMR+) in Nursing Home Residents, Older People and Prescribing, sponsored by Amsterdam UMC, location VUmc. Recruiting at 7 sites in Netherlands. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2024-12-12.
Sponsored by Amsterdam UMC, location VUmc · Not applicable, Interventional, and Supportive care
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.
Amsterdam UMC, location VUmc is the lead sponsor of 302 studies on the registry; 84 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Nursing home patients:
Exclusion Criteria:
Control group, care as usual
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.
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 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.
Also known as: ReNeWAL criteria, Pocket card
Potential under- and overprescribing
Potential under- and overprescribing
Time frame: at baseline - 6 months - 12 months
Experienced involvement in decision-making
Experienced involvement in decision-making measured with a questionnaire
Time frame: At baseline and 2-4 weeks after the medication review
QOL (Quality of life)
Quality of life measured with the EuroQol questionnaire (EQ-5D)
Time frame: at baseline - 6 months - 12 months
Social wellbeing
Measured with Revised index for social engagement (RISE) questionnaire
Time frame: 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.)
Time frame: 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
Time frame: at baseline - 6 months - 12 months
Process evaluation
Qualitative and quantitative data
Time frame: Through 1 year and 3 months
Plan to share: No
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Amsterdam UMC, location VUmc