NCT01876095

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
992

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 10, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 12, 2013

Completed
12 months until next milestone

Study Start

First participant enrolled

June 1, 2014

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

March 22, 2017

Status Verified

March 1, 2017

Enrollment Period

1.8 years

First QC Date

June 10, 2013

Last Update Submit

March 20, 2017

Conditions

Polypharmacy Because of Multimorbidity in Geriatric Nursing Home Residents

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (11)

  • Medication initiation

    4 months

  • Dose adjustment

    4 months

  • Safer alternative medication

    4 months

  • Drug burden index

    4 months

  • Quality of Life

    4 months

  • +6 more secondary outcomes

Other Outcomes (2)

  • Cognitive function

    4 months

  • Neuropsychiatric Symptoms

    4 months

Study Arms (2)

Multidisciplinary medication review

EXPERIMENTAL

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

usual care

NO INTERVENTION

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

Interventions

Multidisciplinary medication reviewPROCEDURE

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.

Multidisciplinary medication review

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Long stay ward
  • Capability and commitment to perform a multidisciplinary multistep medication review.

You may not qualify if:

  • 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:
  • 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.
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Groningen

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

Location

Related Publications (2)

  • 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.

    PMID: 29052691DERIVED

  • 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.

    PMID: 25296655DERIVED

Study Officials

  • Katja Taxis, PhD

    Groningen University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Pharmacotherapy and Clinical Pharmacy

Study Record Dates

First Submitted

June 10, 2013

First Posted

June 12, 2013

Study Start

June 1, 2014

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

March 22, 2017

Record last verified: 2017-03

Locations

NL(1)