Improved Prescribing for Older Nursing Home Patients (IMPETUS)

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).

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.

Study Overview

• Status: Recruiting
• Conditions: Older People; Decision Making; Advance Care Planning; Prescribing Practices; Nursing Home Residents; Prescribing; Medication Reviews
• Intervention / Treatment: Combination product: Systematic multidisciplinary medication review + ACP (SMMR+)

Detailed Description

Additional information on the method:

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

• Study Type: Interventional
• Enrollment (Estimated): 450
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marlies Dijk, MD; Phone Number: 0031 020-4445785; Email: m.dijk5@amsterdamumc.nl
• Study Contact Backup: Name: Eefje Sizoo, MD, PhD; Phone Number: 0031 020-4445785; Email: e.sizoo@amsterdamumc.nl

Study Locations

• Netherlands
  • Groningen, Netherlands, 9743XV
    • Active, not recruiting
    • Dignis, location de Veldspaat
  • Gelderland
    • Apeldoorn, Gelderland, Netherlands, 7334DV
      • Active, not recruiting
      • Zorggroep Apeldoorn, location Randerode, De Hofstede and De Windkanter
    • Harderwijk, Gelderland, Netherlands, 3844 JW
      • Active, not recruiting
      • Zorggroep Noordwest-Veluwe, locaties Weideheem en de Arcade
  • Noord Holland
    • Amsterdam, Noord Holland, Netherlands, 1057 DZ
      • Recruiting
      • Cordaan, location Nieuw Vredenburgh
      • Contact: Phone Number: (0031) 020-5898650
  • Noord-Holland
    • Hilversum, Noord-Holland, Netherlands, 1215 SE
      • Active, not recruiting
      • Amaris, Location Alporti and Rubina
  • Utrecht
    • Ijsselstein, Utrecht, Netherlands, 3401 BN
      • Recruiting
      • AxionContinu, location Isselwaerde and de Schutse
      • Contact: Phone Number: (0031) 030-6881914
    • Vianen, Utrecht, Netherlands, 4133 GX
      • Recruiting
      • Zorgspectrum, location de Plataan
      • Contact: Phone Number: (0031) 030-6007140

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Control group, care as usual
Experimental: Educational intervention; 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: 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.; Other Names: ReNeWAL criteria; Pocket card

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Potential under- and overprescribing	Potential under- and overprescribing	at baseline - 6 months - 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Experienced involvement in decision-making	Experienced involvement in decision-making measured with a questionnaire	At baseline and 2-4 weeks after the medication review

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
QOL (Quality of life)	Quality of life measured with the EuroQol questionnaire (EQ-5D)	at baseline - 6 months - 12 months
Social wellbeing	Measured with Revised index for social engagement (RISE) questionnaire	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.)	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	at baseline - 6 months - 12 months
Process evaluation	Qualitative and quantitative data	Through 1 year and 3 months

Collaborators and Investigators

• Sponsor: Amsterdam UMC, location VUmc
• Collaborators: ZonMw: The Netherlands Organisation for Health Research and Development
• Investigators: Study Director: Martin Smalbrugge, Prof, Amsterdam UMC, location VUmc, departement Medicine for Older People

Study record dates

Study Major Dates

• Study Start (Actual): September 10, 2024
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: August 14, 2024
• First Submitted That Met QC Criteria: December 9, 2024
• First Posted (Estimated): December 12, 2024

Study Record Updates

• Last Update Posted (Estimated): December 12, 2024
• Last Update Submitted That Met QC Criteria: December 9, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Educational intervention; Cluster randomised trial; limited life expectancy; ReNeWAL criteria (adjusted STOPP/START criteria); decision making involvement; appropriate prescribing; Prescribing practices
• Other Study ID Numbers: 839160003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No