Discontinuing Inappropriate Medication in Nursing Home Residents

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01876095
Recruitment Status : Completed
First Posted : June 12, 2013
Last Update Posted : March 22, 2017
ZonMw: The Netherlands Organisation for Health Research and Development
Information provided by (Responsible Party):
Katja Taxis, University of Groningen

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.

Condition or disease Intervention/treatment Phase
Polypharmacy Because of Multimorbidity in Geriatric Nursing Home Residents Procedure: Multidisciplinary medication review Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 992 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Discontinuing Inappropriate Medication in Nursing Home Residents (the DIM NHR Study): a Cluster Randomized Controlled Trial
Study Start Date : June 2014
Actual Primary Completion Date : April 2016
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Nursing Homes

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

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

Secondary Outcome Measures :
  1. 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

  2. Dose adjustment [ Time Frame: 4 months ]
    Number of residents for whom ≥1 dose(s) are lowered or increased

  3. Safer alternative medication [ Time Frame: 4 months ]
    The percentage of residents for whom ≥1 medication(s) is replaced by a safer alternative

  4. 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

  5. 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).

  6. adverse drug withdrawal events [ Time Frame: 4 months ]
    The rate of adverse drug withdrawal events related to the discontinued medication

  7. Death [ Time Frame: 4 months ]
    Incidence of death

  8. Hospital admission [ Time Frame: 4 months ]
    Hospital admission

  9. 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

  10. Bone fractures [ Time Frame: 4 months ]
    Bone fractures caused by falling

  11. 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:
  1. 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

  2. Neuropsychiatric Symptoms [ Time Frame: 4 months ]
    Assessment of change in neuropsychiatric symptoms (e.g. hallucinations & delusions) with the Neuropsychiatric Inventory (NPI) (nursing home version).

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01876095

University of Groningen
Groningen, Netherlands, PO Box 72 9700 AB
Sponsors and Collaborators
University of Groningen
ZonMw: The Netherlands Organisation for Health Research and Development
Principal Investigator: Katja Taxis, PhD Groningen University