Discontinuing Inappropriate Medication in Nursing Home Residents

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by University of Groningen
Sponsor:
Collaborator:
ZonMw: The Netherlands Organisation for Health Research and Development
Information provided by (Responsible Party):
Katja Taxis, University of Groningen
ClinicalTrials.gov Identifier:
NCT01876095
First received: June 10, 2013
Last updated: June 19, 2014
Last verified: June 2014
  Purpose

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 Intervention
Polypharmacy Because of Multimorbidity in Geriatric Nursing Home Residents
Procedure: Multidisciplinary medication review

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Official Title: Discontinuing Inappropriate Medication in Nursing Home Residents (the DIM NHR Study): a Cluster Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by University of Groningen:

Primary Outcome Measures:
  • Medication discontinuation [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    the difference in proportion of residents who successfully discontinued medication between intervention and control group


Secondary Outcome Measures:
  • Drug burden index [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]
    A measure of a person's total exposure to anticholinergic and sedative medications, which has been associated with falls in nursing home patients

  • Quality of Life [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    Quality of life will be measured using a disease specific instrument (DQI (Scholzel-Dorenbosch et al, in press) for all patients and a generic instrument EQ-5D-5L for non-dementia patients (Herdman et al, 2011).

  • adverse drug withdrawal events [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]
    The rate of adverse drug withdrawal events related to the discontinued medication

  • Death [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]
    Incidence of death

  • Hospital admission [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]
    Hospital admission

  • Falling [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]
    Defined as any event in which a nursing home resident touches the ground in an unintentional sudden manner without cues of emergency

  • Bone fractures [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]
    Bone fractures caused by falling

  • Gastrointestinal bleedings [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]
    Gastrointestinal bleedings

  • no. visits to outpatient clinics / emergency rooms / by medical consultants [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]
    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:
  • Cognitive function [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    Cognitive function as assessed with standardized cognitive tests called the Severe Impairment Battery and the Mini Mental Status Examination

  • Neuropsychiatric Symptoms [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    Assessment of change in neuropsychiatric symptoms (e.g. hallucinations & delusions) with the Neuropsychiatric Inventory (NPI) (nursing home version).


Estimated Enrollment: 600
Study Start Date: June 2014
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Step #3: Reflecting on results of drug reviewing and application of Garfinkel's algorithm Step #4: Setting up a pharmacotherapeutical action plan Step #5: Implementing 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 criteria.
  • 3/4. Meeting of elderly care physician, pharmacist, nurse, and patient or caregiver. Using algorithm, 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. Implementation 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

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 of 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01876095

Contacts
Contact: Katja Taxis, PhD +31 50 363 8205 k.taxis@rug.nl
Contact: Hans Wouters, PhD +31 50 363 8496 h.wouters@rug.nl

Locations
Netherlands
University of Groningen Recruiting
Groningen, Netherlands, PO Box 72 9700 AB
Principal Investigator: Katja Taxis, PhD         
Sub-Investigator: Hans Wouters, PhD         
Sponsors and Collaborators
University of Groningen
ZonMw: The Netherlands Organisation for Health Research and Development
Investigators
Principal Investigator: Katja Taxis, PhD Groningen University
  More Information

No publications provided

Responsible Party: Katja Taxis, professor Katja Taxis, University of Groningen
ClinicalTrials.gov Identifier: NCT01876095     History of Changes
Other Study ID Numbers: DIM-NHR study
Study First Received: June 10, 2013
Last Updated: June 19, 2014
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

ClinicalTrials.gov processed this record on July 23, 2014