Discontinuing Inappropriate Medication in Nursing Home Residents

NCT ID: NCT01876095

Last Updated: 2017-03-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 992 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2016-04-30

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.

Conditions

Polypharmacy Because of Multimorbidity in Geriatric Nursing Home Residents

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: EXPERIMENTAL

Multidisciplinary medication review

Intervention Type: 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.

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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

• 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

• 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:

• 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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ZonMw: The Netherlands Organisation for Health Research and Development

OTHER

Sponsor Role: collaborator

University of Groningen

OTHER

Sponsor Role: lead

Responsible Party

Katja Taxis

Professor of Pharmacotherapy and Clinical Pharmacy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Katja Taxis, PhD

Role: PRINCIPAL_INVESTIGATOR

Groningen University

Locations

University of Groningen

Groningen, Provincie Groningen, Netherlands

Countries

Netherlands

References

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.

Reference Type: DERIVED

PMID: 29052691 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 25296655 (View on PubMed)

Other Identifiers

DIM-NHR study

Identifier Type: -

Identifier Source: org_study_id