Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| ZonMw: The Netherlands Organisation for Health Research and Development | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multidisciplinary medication review | Procedure | Consists of the following steps:
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Medication initiation | 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 | 4 months |
| Dose adjustment |
| Measure | Description | Time Frame |
|---|---|---|
| Cognitive function | Cognitive function as assessed with standardized cognitive tests called the Severe Impairment Battery and the Mini Mental Status Examination | 4 months |
| Neuropsychiatric Symptoms | Assessment of change in neuropsychiatric symptoms (e.g. hallucinations & delusions) with the Neuropsychiatric Inventory (NPI) (nursing home version). |
Nursing Home Wards:
Inclusion criteria:
Exclusion criteria:
Nursing Home Residents:
Inclusion criteria:
Exclusion criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Katja Taxis, PhD | Groningen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Groningen | Groningen | Provincie Groningen | PO Box 72 9700 AB | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29052691 | Derived | 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. | |
| 25296655 | Derived |
Not provided
Not provided
| Type | Date | Date Unknown |
|---|---|---|
| Release | May 29, 2018 | |
| Reset | Dec 14, 2018 |
Not provided
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 29, 2018 | Dec 14, 2018 |
Not provided
Not provided
Not provided
Not provided
|
Number of residents for whom ≥1 dose(s) are lowered or increased
| 4 months |
| Safer alternative medication | The percentage of residents for whom ≥1 medication(s) is replaced by a safer alternative | 4 months |
| Drug burden index | A measure of a person's cumulative exposure to anticholinergic and sedative medications, which has been associated with falls in nursing home patients | 4 months |
| Quality of Life | 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). | 4 months |
| adverse drug withdrawal events | The rate of adverse drug withdrawal events related to the discontinued medication | 4 months |
| Death | Incidence of death | 4 months |
| Hospital admission | Hospital admission | 4 months |
| Falling | Defined as any event in which a nursing home resident touches the ground in an unintentional sudden manner without cues of emergency | 4 months |
| Bone fractures | Bone fractures caused by falling | 4 months |
| number of visits to outpatient clinics / emergency rooms / by medical consultants | 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, | 4 months |
| 4 months |
| 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. |