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Clinical Trials/NCT06731361
NCT06731361
Recruiting
N/A

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

Amsterdam UMC, location VUmc7 sites in 1 country450 target enrollmentSeptember 10, 2024

Overview

Phase
N/A
Intervention
Not specified
Conditions
Nursing Home Residents
Sponsor
Amsterdam UMC, location VUmc
Enrollment
450
Locations
7
Primary Endpoint
Potential under- and overprescribing
Status
Recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 10, 2024
End Date
December 1, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Amsterdam UMC, location VUmc
Responsible Party
Principal Investigator
Principal Investigator

Martin Smalbrugge

Principal investigator, professor of Medicine for Older People and chair of the Department of Medicine for Older People

Amsterdam UMC, location VUmc

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)

Outcomes

Primary Outcomes

Potential under- and overprescribing

Time Frame: at baseline - 6 months - 12 months

Potential under- and overprescribing

Secondary Outcomes

  • Experienced involvement in decision-making(At baseline and 2-4 weeks after the medication review)

Study Sites (7)

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