Polypharmacy Because of Multimorbidity in Geriatric Nursing Home ResidentsNCT01876095
Discontinuing Inappropriate Medication in Nursing Home Residents
A study testing Multidisciplinary medication review in people with Polypharmacy Because of Multimorbidity in Geriatric Nursing Home Residents, run by University of Groningen at 1 site in Netherlands.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Polypharmacy Because of Multimorbidity in Geriatric Nursing Home Residents
- What is being tested?
- Multidisciplinary medication review
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 992 participants
- Where
- 1 siteNetherlands
- Study dates
- Jun 2014to Apr 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
University of Groningen
Groningen, Provincie Groningen, PO Box 72 9700 AB
About this study
Official title: Discontinuing Inappropriate Medication in Nursing Home Residents (the DIM NHR Study): a Cluster Randomized Controlled Trial
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.
- Being tested
- Multidisciplinary medication review
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multidisciplinary medication reviewProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful medication discontinuation
The number of residents for whom ≥1 inappropriate medication(s) are succesfully discontinued i.e. without relapse or severe withdrawal effects
Measured: 4 months
Secondary outcomes (11)
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
Measured: 4 months
Dose adjustment
Number of residents for whom ≥1 dose(s) are lowered or increased
Measured: 4 months
Safer alternative medication
The percentage of residents for whom ≥1 medication(s) is replaced by a safer alternative
Measured: 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
Measured: 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).
Measured: 4 months
adverse drug withdrawal events
The rate of adverse drug withdrawal events related to the discontinued medication
Measured: 4 months
Death
Incidence of death
Measured: 4 months
Hospital admission
Hospital admission
Measured: 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
Measured: 4 months
Bone fractures
Bone fractures caused by falling
Measured: 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,
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2013 (estimated)
- Study startJun 2014
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Polypharmacy Because of Multimorbidity in Geriatric Nursing Home ResidentsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 992 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Groningen
- Sponsor type
- University, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Responsible party
- Principal investigator, Katja Taxis, University of Groningen
- Investigators
- Katja Taxis, PhD, Principal investigator, Groningen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01876095
- Sponsor's protocol ID
- DIM-NHR study
- Status last verified
- Mar 2017
- First submitted
- 10 Jun 2013
- Last updated
- 22 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 29052691Wouters 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.
PubMed 25296655
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Discontinuing Inappropriate Medication in Nursing Home Residents (the DIM NHR Study): a Cluster Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01876095
- Acronym / sponsor ID
- DIM-NHR study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 992 participants (actual)
- Lead sponsor
- University of GroningenUniversity, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Study start
- Jun 2014
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 12 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multidisciplinary medication review | Experimental | Procedure: Multidisciplinary medication reviewThe 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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).
- Refusal of treatment with medicines.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multidisciplinary medication reviewConsists 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. | Procedure or surgery | Multidisciplinary medication review |
Primary outcome
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
11 secondary outcomes
Medication initiation
Time frame: 4 months
Dose adjustment
Time frame: 4 months
Safer alternative medication
Time frame: 4 months
Drug burden index
Time frame: 4 months
Quality of Life
Time frame: 4 months
adverse drug withdrawal events
Time frame: 4 months
Death
Time frame: 4 months
Hospital admission
Time frame: 4 months
Falling
Time frame: 4 months
Bone fractures
Time frame: 4 months
number of visits to outpatient clinics / emergency rooms / by medical consultants
Time frame: 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2017.
- Derived from this study: PubMed 29052691Wouters 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.
- Derived from this study: PubMed 25296655Wouters 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katja Taxis, PhD principal investigator
Groningen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multidisciplinary medication review in people with Polypharmacy Because of Multimorbidity in Geriatric Nursing Home Residents, run by University of Groningen at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful medication discontinuation (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01876095, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2017.