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NCT Number: NCT06731361

Improved Prescribing for Older Nursing Home Patients

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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zorggroep Apeldoorn, location Randerode, De Hofstede and De Windkanter, Apeldoorn, Gelderland, Netherlands

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About this study

Additional information on the method:

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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:

  • 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

Primary outcomes

  1. Potential under- and overprescribing

    Time frame: at baseline - 6 months - 12 months

    Potential under- and overprescribing

Secondary outcomes

  1. Experienced involvement in decision-making

    Time frame: At baseline and 2-4 weeks after the medication review

    Experienced involvement in decision-making measured with a questionnaire

Other outcomes

  1. QOL (Quality of life)

    Time frame: at baseline - 6 months - 12 months

    Quality of life measured with the EuroQol questionnaire (EQ-5D)

  2. Social wellbeing

    Time frame: at baseline - 6 months - 12 months

    Measured with Revised index for social engagement (RISE) questionnaire

  3. Adverse outcomes

    Time frame: at baseline - 6 months - 12 months

    Adverse outcomes, such as: deaths, falls, hospital admissions/acute referrals, measured over the previous 6 months. (Only for ' deaths' not possible at baseline.)

  4. Pain assessment

    Time frame: at baseline - 6 months - 12 months

    measured with the pain items of the Resident Assessment Instrument for Long-term Care Facilities (RAI-LTCF) questionnaire

  5. Process evaluation

    Time frame: Through 1 year and 3 months

    Qualitative and quantitative data

Study contacts

Contact information is provided by the study sponsor or research team.

Eefje Sizoo, MD, PhD

CONTACT

[email protected]

020-4445785 ext. 0031

Marlies Dijk, MD

CONTACT

[email protected]

020-4445785 ext. 0031

Sponsors and collaborators

Lead sponsor

Amsterdam UMC, location VUmc

Other

Collaborators

  • ZonMw: The Netherlands Organisation for Health Research and Development

Registry information

Official study title

Improving Medication Prescription in the contExt of Advance Care Planning for paTients Receiving Long Term nUrSing Home Care

Acronym: IMPETUS

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 12, 2024
Registry last updated
Dec 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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