Discontinuing Inappropriate Medication in Nursing Home Residents
This study has been completed.
First Posted: June 12, 2013
Last Update Posted: March 22, 2017
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ZonMw: The Netherlands Organisation for Health Research and Development
Information provided by (Responsible Party):
Katja Taxis, University of Groningen
Nursing home residents are among the frailest patient groups with a high number of co-morbidities and a high use of medicines. Inappropriate polypharmacy (i.e. often overprescribing) is one of the major problems in the nursing home population increasing the number of adverse drug reactions, falls, hospital admissions, mortality as well as having an impact on health care utilization. Multidisciplinary medication reviews have a great potential to reduce inappropriate medication use. The purpose of this study is to determine the efficacy of a multidisciplinary medication review model focussing on discontinuing inappropriate medication in a cluster randomized controlled trial in 600 nursing home residents. The primary outcome measure is the difference in proportion of residents who successfully discontinued medication between intervention and control group after four months. Secondary outcome measures will be the drug burden index, adverse drug withdrawal events related to the discontinued medication, death, referral to hospitals and quality of life.
Polypharmacy Because of Multimorbidity in Geriatric Nursing Home Residents
Procedure: Multidisciplinary medication review
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Supportive Care
||Discontinuing Inappropriate Medication in Nursing Home Residents (the DIM NHR Study): a Cluster Randomized Controlled Trial
Primary Outcome Measures:
Secondary Outcome Measures:
- Medication initiation [ Time Frame: 4 months ]
Number of residents for whom ≥1 medication(s) are initiated (s) that should be started on the basis of the Screening Tool to Alert doctors to Right Treatment (START) criteria
- Dose adjustment [ Time Frame: 4 months ]
Number of residents for whom ≥1 dose(s) are lowered or increased
- Safer alternative medication [ Time Frame: 4 months ]
The percentage of residents for whom ≥1 medication(s) is replaced by a safer alternative
- Drug burden index [ Time Frame: 4 months ]
A measure of a person's cumulative exposure to anticholinergic and sedative medications, which has been associated with falls in nursing home patients
- Quality of Life [ Time Frame: 4 months ]
Quality of life will be measured using a disease specific instrument (DQI (Scholzel-Dorenbosch et al, in press) and a generic instrument EQ-5D-5L for all patients (Herdman et al, 2011).
- adverse drug withdrawal events [ Time Frame: 4 months ]
The rate of adverse drug withdrawal events related to the discontinued medication
- Death [ Time Frame: 4 months ]
Incidence of death
- Hospital admission [ Time Frame: 4 months ]
- Falling [ Time Frame: 4 months ]
Defined as any event in which a nursing home resident touches the ground in an unintentional sudden manner without cues of emergency
- Bone fractures [ Time Frame: 4 months ]
Bone fractures caused by falling
- number of visits to outpatient clinics / emergency rooms / by medical consultants [ Time Frame: 4 months ]
number of visits to outpatient clinics, emergency rooms, number of visits by medical consultants i.e. physicians who visit the patients in the nursing homes,
Other Outcome Measures:
- Cognitive function [ Time Frame: 4 months ]
Cognitive function as assessed with standardized cognitive tests called the Severe Impairment Battery and the Mini Mental Status Examination
- Neuropsychiatric Symptoms [ Time Frame: 4 months ]
Assessment of change in neuropsychiatric symptoms (e.g. hallucinations & delusions) with the Neuropsychiatric Inventory (NPI) (nursing home version).
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||April 2016 (Final data collection date for primary outcome measure)
Experimental: Multidisciplinary medication review
The multidisciplinary medication review consists of 5 steps:
Step #1: Assessing patients' experiences and preferences regarding medicine use en assessing their medical history, allergies and lab results Step #2: Drug reviewing to assess contra-indicated medication and duplicate medication using consensus criteria e.g. START STOPP Beers criteria Step #3: Reflecting on results of drug reviewing Step #4: Setting up a pharmacotherapeutical action plan Step #5: Execution of pharmacotherapeutical action plan
Procedure: Multidisciplinary medication review
Consists of the following steps:
- 1. Elderly care physician and nursing staff evaluate with the patient the experience of taking medicines, adverse drug reactions and patient's preferences.
- 2. Pharmacist reviews medication to identify drug related problems using START/STOPP en Beers criteria.
- 3/4. Meeting of elderly care physician, pharmacist. Possibilities to discontinue prescribed medication will be examined resulting in pharmaceutical care plan that optimizes the patient's medication i.e. which inappropriate medication should be discontinued following a prioritization and time schedule.
- 5. Execution of pharmaceutical care plan according to agreed schedule.
No Intervention: usual care
Includes medication safety monitoring and ad hoc medication reviews on clinical indication that differ in quality and frequency, but no standardized multidisciplinary multistep medication reviews in the way as described for the intervention arm