Improved Prescribing for Older Nursing Home Patients

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorAmsterdam UMC, location VUmc

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

450 Participants
are divided into 2 treatment groups
Group A: ControlNo intervention 0 interventions
Group B: Educational interventionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Potential under- and overprescribing

Potential under- and overprescribing

Time frame
at baseline - 6 months - 12 months

Secondary outcomes

1

Experienced involvement in decision-making

Experienced involvement in decision-making measured with a questionnaire

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

Other outcomes

1

QOL (Quality of life)

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

Time frame
at baseline - 6 months - 12 months
2

Social wellbeing

Measured with Revised index for social engagement (RISE) questionnaire

Time frame
at baseline - 6 months - 12 months
3

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.)

Time frame
at baseline - 6 months - 12 months
4

Pain assessment

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

Time frame
at baseline - 6 months - 12 months

Sponsors and contacts

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Amsterdam UMC, location VUmc

Lead sponsor

ZonMw: The Netherlands Organisation for Health Research and Development

Collaborator