Discontinuing Inappropriate Medication in Nursing Home Residents

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

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.

Study Overview

• Status: Completed
• Conditions: Polypharmacy Because of Multimorbidity in Geriatric Nursing Home Residents
• Intervention / Treatment: Procedure: Multidisciplinary medication review

• Study Type: Interventional
• Enrollment (Actual): 992
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Groningen, Netherlands, PO Box 72 9700 AB
    • University of Groningen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Successful medication discontinuation	The number of residents for whom ≥1 inappropriate medication(s) are succesfully discontinued i.e. without relapse or severe withdrawal effects	4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Medication initiation	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	4 months
Dose adjustment	Number of residents for whom ≥1 dose(s) are lowered or increased	4 months
Safer alternative medication	The percentage of residents for whom ≥1 medication(s) is replaced by a safer alternative	4 months
Drug burden index	A measure of a person's cumulative exposure to anticholinergic and sedative medications, which has been associated with falls in nursing home patients	4 months
Quality of Life	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).	4 months
adverse drug withdrawal events	The rate of adverse drug withdrawal events related to the discontinued medication	4 months
Death	Incidence of death	4 months
Hospital admission	Hospital admission	4 months
Falling	Defined as any event in which a nursing home resident touches the ground in an unintentional sudden manner without cues of emergency	4 months
Bone fractures	Bone fractures caused by falling	4 months
number of visits to outpatient clinics / emergency rooms / by medical consultants	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,	4 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cognitive function	Cognitive function as assessed with standardized cognitive tests called the Severe Impairment Battery and the Mini Mental Status Examination	4 months
Neuropsychiatric Symptoms	Assessment of change in neuropsychiatric symptoms (e.g. hallucinations & delusions) with the Neuropsychiatric Inventory (NPI) (nursing home version).	4 months

Collaborators and Investigators

• Sponsor: University of Groningen
• Collaborators: ZonMw: The Netherlands Organisation for Health Research and Development
• Investigators: Principal Investigator: Katja Taxis, PhD, Groningen University

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (Actual): April 1, 2016
• Study Completion (Actual): April 1, 2016

Study Registration Dates

• First Submitted: June 10, 2013
• First Submitted That Met QC Criteria: June 10, 2013
• First Posted (Estimate): June 12, 2013

Study Record Updates

• Last Update Posted (Actual): March 22, 2017
• Last Update Submitted That Met QC Criteria: March 20, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: DIM-NHR study