Clinical trial NCT06731361: Improved Prescribing for Older Nursing Home Patients
Official title: Improving Medication Prescription in the contExt of Advance Care Planning for paTients Receiving Long Term nUrSing Home Care
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Nursing Home Residents
Older People
Prescribing
Advance Care Planning
Medication Reviews
Decision Making
Prescribing Practices
Keywords: limited life expectancy
ReNeWAL criteria (adjusted STOPP/START criteria)
decision making involvement
appropriate prescribing
Cluster randomised trial
Educational intervention
Prescribing practices
Lead sponsor: Amsterdam UMC, location VUmc
Sponsor class: OTHER
Collaborators: name: ZonMw: The Netherlands Organisation for Health Research and Development
First posted: 2024-12-12
Enrollment: 450
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: Additional information on the method:

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

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)

Primary outcomes:
measure: Potential under- and overprescribing
timeFrame: at baseline - 6 months - 12 months
Secondary outcomes:
measure: Experienced involvement in decision-making
timeFrame: At baseline and 2-4 weeks after the medication review
Other outcomes:
measure: QOL (Quality of life)
timeFrame: at baseline - 6 months - 12 months
measure: Social wellbeing
timeFrame: at baseline - 6 months - 12 months
measure: Adverse outcomes
timeFrame: at baseline - 6 months - 12 months
measure: Pain assessment
timeFrame: at baseline - 6 months - 12 months
measure: Process evaluation
timeFrame: Through 1 year and 3 months
Locations:
city: Apeldoorn
country: Netherlands
facility: Zorggroep Apeldoorn, location Randerode, De Hofstede and De Windkanter
state: Gelderland
city: Harderwijk
country: Netherlands
facility: Zorggroep Noordwest-Veluwe, locaties Weideheem en de Arcade
state: Gelderland
city: Amsterdam
country: Netherlands
facility: Cordaan, location Nieuw Vredenburgh
state: Noord Holland
city: Hilversum
country: Netherlands
facility: Amaris, Location Alporti and Rubina
state: Noord-Holland
city: Ijsselstein
country: Netherlands
facility: AxionContinu, location Isselwaerde and de Schutse
state: Utrecht
city: Vianen
country: Netherlands
facility: Zorgspectrum, location de Plataan
state: Utrecht
city: Groningen
country: Netherlands
facility: Dignis, location de Veldspaat
Study officials:
affiliation: Amsterdam UMC, location VUmc, departement Medicine for Older People
name: Martin Smalbrugge, Prof
role: STUDY_DIRECTOR
References: