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Completed

NCT Number: NCT01876095

Discontinuing Inappropriate Medication in Nursing Home Residents

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.

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Key information

Conditions

Polypharmacy Because of Multimorbidity in Geriatric Nursing Home Residents

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Groningen

Groningen, Provincie Groningen, PO Box 72 9700 AB, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Multidisciplinary medication review

Procedure

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.

Primary outcomes

  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 outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

University of Groningen

Other

Collaborators

  • ZonMw: The Netherlands Organisation for Health Research and Development

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jun 12, 2013
Registry last updated
Mar 22, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.