Nursing Home ResidentsIMPETUSNCT06731361
Improved Prescribing for Older Nursing Home Patients
A study testing Systematic multidisciplinary medication review + ACP (SMMR+) in people with Nursing Home Residents and Older People, run by Amsterdam UMC, location VUmc at 7 sites in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Nursing Home Residents, Older People, Prescribing
- What is being tested?
- Systematic multidisciplinary medication review + ACP (SMMR+)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 7 sitesNetherlands
- Study dates
- 10 Sep 2024to 1 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
Netherlands7 sites, 3 recruiting
- Recruiting
Cordaan, location Nieuw Vredenburgh
Amsterdam, North Holland, 1057 DZ
(0031) 020-5898650
- Active, not recruiting
Zorggroep Apeldoorn, location Randerode, De Hofstede and De Windkanter
Apeldoorn, Gelderland, 7334DV
- Active, not recruiting
Dignis, location de Veldspaat
Groningen, 9743XV
- Active, not recruiting
Zorggroep Noordwest-Veluwe, locaties Weideheem en de Arcade
Harderwijk, Gelderland, 3844 JW
- Active, not recruiting
Amaris, Location Alporti and Rubina
Hilversum, North Holland, 1215 SE
- Recruiting
AxionContinu, location Isselwaerde and de Schutse
IJsselstein, Utrecht, 3401 BN
(0031) 030-6881914
- Recruiting
Zorgspectrum, location de Plataan
Vianen, Utrecht, 4133 GX
(0031) 030-6007140
About this study
Official title: Improving Medication Prescription in the contExt of Advance Care Planning for paTients Receiving Long Term nUrSing Home 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).
Read more
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.
Read the detailed description
Additional information on the method:
We included 2 nursinghome organizations in september, 2 in october, and 3 in november.
- Conditions
- Nursing Home Residents, Older People, Prescribing, Advance Care Planning, Medication Reviews, Decision Making
- Being tested
- Systematic multidisciplinary medication review + ACP (SMMR+)
- Keywords
- limited life expectancy, ReNeWAL criteria (adjusted STOPP/START criteria), decision making involvement, appropriate prescribing, Cluster randomised trial, Educational intervention, Prescribing practices
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Systematic multidisciplinary medication review + ACP (SMMR+)Combination product
Also called ReNeWAL criteria, Pocket card
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:
- Medication assessment with the use of the ReNeWAL criteria (adjusted STOPP/START criteria, tailored to nursing home patients with a limited life expectancy)
- 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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Combination Product: Systematic multidisciplinary medication review + ACP (SMMR+) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Potential under- and overprescribing
Potential under- and overprescribing
Measured: at baseline - 6 months - 12 months
Secondary outcomes (1)
Experienced involvement in decision-making
Experienced involvement in decision-making measured with a questionnaire
Measured: At baseline and 2-4 weeks after the medication review
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2024
- Study start10 Sep 2024
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nursing Home ResidentsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amsterdam UMC, location VUmc
- Sponsor type
- University, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Responsible party
- Principal investigator, Martin Smalbrugge, Amsterdam UMC, location VUmc
- Investigators
- Martin Smalbrugge, Prof, Study director, Amsterdam UMC, location VUmc, departement Medicine for Older People
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06731361
- Sponsor's protocol ID
- 839160003
- Acronym
- IMPETUS
- Status last verified
- Dec 2024
- First submitted
- 14 Aug 2024
- Last updated
- 12 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Medication Prescription in the contExt of Advance Care Planning for paTients Receiving Long Term nUrSing Home Care
- ClinicalTrials.gov ID
- NCT06731361
- Acronym / sponsor ID
- IMPETUS / 839160003
- Conditions
- Nursing Home Residents, Older People, Prescribing, Advance Care Planning, Medication Reviews, Decision Making
- Keywords
- limited life expectancy, ReNeWAL criteria (adjusted STOPP/START criteria), decision making involvement, appropriate prescribing, Cluster randomised trial, Educational intervention, Prescribing practices
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Amsterdam UMC, location VUmcUniversity, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Study start
- 10 Sep 2024 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 12 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Control group, care as usual |
| Educational intervention | Experimental | Combination Product: Systematic multidisciplinary medication review + ACP (SMMR+)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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Systematic multidisciplinary medication review + ACP (SMMR+)Also: ReNeWAL criteria, Pocket cardThe 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. | Combination product | Educational intervention |
Primary outcome
Potential under- and overprescribing
Time frame: at baseline - 6 months - 12 months
Potential under- and overprescribing
1 secondary outcome
Experienced involvement in decision-making
Time frame: At baseline and 2-4 weeks after the medication review
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Martin Smalbrugge, Prof study director
Amsterdam UMC, location VUmc, departement Medicine for Older People
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Systematic multidisciplinary medication review + ACP (SMMR+) in people with Nursing Home Residents and Older People, run by Amsterdam UMC, location VUmc at 7 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marlies Dijk, MD (020-4445785 ext. 0031, m.dijk5@amsterdamumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Potential under- and overprescribing (time frame: at baseline - 6 months - 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2024.