Improved Prescribing for Older Nursing Home Patients

NCT06731361 | Recruiting

• 1 other identifier: 839160003
• Study Type: interventional
• Target: 450
• Locations: 1 country
• Sites: 7

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.

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

Outcome Measures

Primary Outcomes (1)

• Potential under- and overprescribing

  Potential under- and overprescribing

  at baseline - 6 months - 12 months

Secondary Outcomes (1)

• Experienced involvement in decision-making

  At baseline and 2-4 weeks after the medication review

Other Outcomes (5)

• QOL (Quality of life)

  at baseline - 6 months - 12 months

• Social wellbeing

  at baseline - 6 months - 12 months

• Adverse outcomes

  at baseline - 6 months - 12 months

Study Arms (2)

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.

Combination Product: Systematic multidisciplinary medication review + ACP (SMMR+)

Interventions

Systematic multidisciplinary medication review + ACP (SMMR+) COMBINATION_PRODUCT

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

Educational intervention

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Amsterdam UMC, location VUmc: lead
• ZonMw: The Netherlands Organisation for Health Research and Development: collaborator

Study Sites (7)

Zorggroep Apeldoorn, location Randerode, De Hofstede and De Windkanter

Apeldoorn, Gelderland, 7334DV, Netherlands

ACTIVE NOT RECRUITING

Zorggroep Noordwest-Veluwe, locaties Weideheem en de Arcade

Harderwijk, Gelderland, 3844 JW, Netherlands

ACTIVE NOT RECRUITING

Cordaan, location Nieuw Vredenburgh

Amsterdam, North Holland, 1057 DZ, Netherlands

RECRUITING

Amaris, Location Alporti and Rubina

Hilversum, North Holland, 1215 SE, Netherlands

ACTIVE NOT RECRUITING

AxionContinu, location Isselwaerde and de Schutse

IJsselstein, Utrecht, 3401 BN, Netherlands

RECRUITING

Zorgspectrum, location de Plataan

Vianen, Utrecht, 4133 GX, Netherlands

RECRUITING

Dignis, location de Veldspaat

Groningen, 9743XV, Netherlands

ACTIVE NOT RECRUITING

Study Officials

• Martin Smalbrugge, Prof

  Amsterdam UMC, location VUmc, departement Medicine for Older People

  STUDY DIRECTOR

Central Study Contacts

Marlies Dijk, MD

CONTACT

020-4445785; m.dijk5@amsterdamumc.nl

Eefje Sizoo, MD, PhD

CONTACT

020-4445785; e.sizoo@amsterdamumc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Not possible due to the type of intervention
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator, professor of Medicine for Older People and chair of the Department of Medicine for Older People

Model Details: 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.

Study Record Dates

• First Submitted: August 14, 2024
• First Posted: December 12, 2024
• Study Start: September 10, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: December 12, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

NL (7)