Clinical trial NCT01876095: Discontinuing Inappropriate Medication in Nursing Home Residents
Official title: Discontinuing Inappropriate Medication in Nursing Home Residents (the DIM NHR Study): a Cluster Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Polypharmacy Because of Multimorbidity in Geriatric Nursing Home Residents
Lead sponsor: University of Groningen
Sponsor class: OTHER
Collaborators: name: ZonMw: The Netherlands Organisation for Health Research and Development
First posted: 2013-06-12
Enrollment: 992
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility 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.

Exclusion criteria:

* Refusal of treatment with medicines.
* Having received a multidisciplinary systematic medication review in the past 6 months.
* Being terminally ill and having a life expectancy ≤ 4 weeks as judged by the treating elderly care physician.
* Other reasons at the discretion of the elderly care physician / nursing staff

Primary outcomes:
measure: Successful medication discontinuation
timeFrame: 4 months
Secondary outcomes:
measure: Medication initiation
timeFrame: 4 months
measure: Dose adjustment
timeFrame: 4 months
measure: Safer alternative medication
timeFrame: 4 months
measure: Drug burden index
timeFrame: 4 months
measure: Quality of Life
timeFrame: 4 months
measure: adverse drug withdrawal events
timeFrame: 4 months
measure: Death
timeFrame: 4 months
measure: Hospital admission
timeFrame: 4 months
measure: Falling
timeFrame: 4 months
measure: Bone fractures
timeFrame: 4 months
measure: number of visits to outpatient clinics / emergency rooms / by medical consultants
timeFrame: 4 months
Other outcomes:
measure: Cognitive function
timeFrame: 4 months
measure: Neuropsychiatric Symptoms
timeFrame: 4 months
Locations:
city: Groningen
country: Netherlands
facility: University of Groningen
Study officials:
affiliation: Groningen University
name: Katja Taxis, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wouters H, Scheper J, Koning H, Brouwer C, Twisk JW, van der Meer H, Boersma F, Zuidema SU, Taxis K. Discontinuing Inappropriate Medication Use in Nursing Home Residents: A Cluster Randomized Controlled Trial. Ann Intern Med. 2017 Nov 7;167(9):609-617. doi: 10.7326/M16-2729. Epub 2017 Oct 10.
citation: Wouters H, Quik EH, Boersma F, Nygard P, Bosman J, Bottger WM, Mulder H, Maring JG, Wijma-Vos L, Beerden T, van Doormaal J, Postma MJ, Zuidema SU, Taxis K. Discontinuing inappropriate medication in nursing home residents (DIM-NHR Study): protocol of a cluster randomised controlled trial. BMJ Open. 2014 Oct 8;4(10):e006082. doi: 10.1136/bmjopen-2014-006082.