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Discontinuing Inappropriate Medication in Nursing Home Residents

Discontinuing Inappropriate Medication in Nursing Home Residents (the DIM NHR Study): a Cluster Randomized Controlled Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01876095
Enrollment
992
Registered
2013-06-12
Start date
2014-06-30
Completion date
2016-04-30
Last updated
2017-03-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Polypharmacy Because of Multimorbidity in Geriatric Nursing Home Residents

Brief summary

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.

Interventions

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.

Sponsors

ZonMw: The Netherlands Organisation for Health Research and Development
CollaboratorOTHER
University of Groningen
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

Nursing Home Wards: Inclusion criteria: * Long stay ward * Capability and commitment to perform a multidisciplinary multistep medication review.

Exclusion criteria

* Short stay, revalidation or observation wards * Specialized ward where patients with an atypical etiology are cared for. * Elderly care physicians who have recently received or who are to receive recertification at short notice with regard to systematic medication review methodology. * Participation in other studies aimed at improving the quality of drug prescription (in the past 12 months). Nursing Home Residents: Inclusion criteria: * A life expectancy of \>4 weeks as judged by the treating elderly care physician. * IC provided by patients themselves or provided by a legal representative for incapacitated patients.

Design outcomes

Primary

MeasureTime frameDescription
Successful medication discontinuation4 monthsThe number of residents for whom ≥1 inappropriate medication(s) are succesfully discontinued i.e. without relapse or severe withdrawal effects

Secondary

MeasureTime frameDescription
Medication initiation4 monthsNumber 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 adjustment4 monthsNumber of residents for whom ≥1 dose(s) are lowered or increased
Safer alternative medication4 monthsThe percentage of residents for whom ≥1 medication(s) is replaced by a safer alternative
Drug burden index4 monthsA measure of a person's cumulative exposure to anticholinergic and sedative medications, which has been associated with falls in nursing home patients
Quality of Life4 monthsQuality 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 events4 monthsThe rate of adverse drug withdrawal events related to the discontinued medication
Bone fractures4 monthsBone fractures caused by falling
number of visits to outpatient clinics / emergency rooms / by medical consultants4 monthsnumber of visits to outpatient clinics, emergency rooms, number of visits by medical consultants i.e. physicians who visit the patients in the nursing homes,
Death4 monthsIncidence of death
Hospital admission4 monthsHospital admission
Falling4 monthsDefined as any event in which a nursing home resident touches the ground in an unintentional sudden manner without cues of emergency

Other

MeasureTime frameDescription
Cognitive function4 monthsCognitive function as assessed with standardized cognitive tests called the Severe Impairment Battery and the Mini Mental Status Examination
Neuropsychiatric Symptoms4 monthsAssessment of change in neuropsychiatric symptoms (e.g. hallucinations & delusions) with the Neuropsychiatric Inventory (NPI) (nursing home version).

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 8, 2026