Advance Care Planning, Decision Making, Medication Reviews, Nursing Home Residents, Older People, Prescribing, Prescribing Practices
Conditions
Keywords
limited life expectancy, ReNeWAL criteria (adjusted STOPP/START criteria), decision making involvement, appropriate prescribing, Cluster randomised trial, Educational intervention, Prescribing practices
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.
Interventions
COMBINATION_PRODUCTSystematic 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: 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.
Sponsors
ZonMw: The Netherlands Organisation for Health Research and Development
Amsterdam UMC, location VUmc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Masking description
Not possible due to the type of intervention
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Potential under- and overprescribing | at baseline - 6 months - 12 months | Potential under- and overprescribing |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Experienced involvement in decision-making | At baseline and 2-4 weeks after the medication review | Experienced involvement in decision-making measured with a questionnaire |
Other
| Measure | Time frame | Description |
|---|---|---|
| Adverse outcomes | 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.) |
| QOL (Quality of life) | at baseline - 6 months - 12 months | Quality of life measured with the EuroQol questionnaire (EQ-5D) |
| Process evaluation | Through 1 year and 3 months | Qualitative and quantitative data |
| Pain assessment | at baseline - 6 months - 12 months | measured with the pain items of the Resident Assessment Instrument for Long-term Care Facilities (RAI-LTCF) questionnaire |
| Social wellbeing | at baseline - 6 months - 12 months | Measured with Revised index for social engagement (RISE) questionnaire |
Countries
Netherlands
Contacts
Primary ContactMarlies Dijk, MD
Backup ContactEefje Sizoo, MD, PhD
Outcome results
None listed