Cognitive ImpairmentNCT01504672
An Intervention Study to Reduce Drug-related Problems and Readmissions Among Old People With Dementia
A study testing Medication review in people with Cognitive Impairment, run by Umeå University at 2 sites in Sweden.
Trial summary
The aim of this randomized controlled study is to investigate if medication reviews performed by a clinical pharmacist as part of a ward team can reduce drug related problems and reduce readmissions to hospital among elderly patients (≥65 years) with dementia and cognitive failure. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Cognitive Impairment
- What is being tested?
- Medication review
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 460 participants
- Where
- 2 sitesSweden
- Study dates
- Jan 2012to Aug 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patients with dementia or cognitive impairment
- Patients ≥ 65 years
Who cannot join
- Patients previously admitted to the study wards during the study period
Trial locations and contacts
2 sites in 1 country.
Sweden2 sites
County hospital of Skellefteå
Skellefteå, 931 86
Umeå University Hospital
Umeå, 901 85
About this study
Official title: A Randomized Controlled Pharmacist Intervention Study to Reduce Drug-related Problems and Readmissions Among Old People With Dementia
The aim of this randomized controlled study is to investigate if medication reviews performed by a clinical pharmacist as part of a ward team can reduce drug related problems and reduce readmissions to hospital among elderly patients (≥65 years) with dementia and cognitive failure.
Four hundred and sixty patients will be recruited and randomized to control (usual care) and intervention group (enhanced service in which a pharmacist is part of the health care team).
Six months after the last patient of the 460 has been discharged the study will be closed. Data about the number of readmissions and visits to the emergency room will be collected during the six-month follow-up and also, the costs associated with each visit or admission. Time until institutionalization will be compared between intervention group and control group.
- Conditions
- Cognitive Impairment
- Being tested
- Medication review
- Keywords
- Drug related problems
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medication reviewOther
In the intervention, the pharmacist will evaluate:
- Is there an indication for the drug?
- Has the drug desired effect?
- Is the dose correct and dosing scheme correct?
- Side effects, contraindications, inappropriate drugs
- Interactions
- Treatment time
- Cost effectiveness
- Adherence to recommendation list
- Problems with handling the drugs (for example crushing of the tablets)
- Untreated indication
- Double medications
- Administration of drugs
| Study group | Role | What they receive |
|---|---|---|
| Medication review | Experimental | Not described Receives: Other: Medication review |
| Usual care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients Readmitted Because of Drug Related Reasons
Measured: Six months follow-up
Secondary outcomes (4)
Cost for Visits for Readmissions and to the Emergency Department Compared Between Patients in the Control Group and Intervention Group.
To evaluate the economic impact of clinical pharmacist engagement in hospital ward teams for medication therapy management in older patients with dementia or cognitive impairments.
Measured: Six months follow-up
Number of Participants Institutionalized After Discharge, in Control Group and Intervention Group.
Measured: Six months follow-up
Frequency of Emergency Department Visits During the 6-month Follow-up.
Measured: Six months follow-up
Change in the Number of Participants With Potentially Inappropriate Medications, According to the Swedish National Board of Health and Welfare, at Admission and Discharge Between Intervention and Control Group
Six drug-specific quality indicators as defined by the Swedish National Board of Health and Welfare were used to define use of Potentially inappropriate medications (PIMs) in this study. Four out of the six selected indicators belong to a group where drug-use should be as low as possible regardless of indication: anticholinergic drugs (as defined by the Swedish National Board of Health and Welfare, propiomazine, tramadol, and long-acting benzodiazepines. The two remaining indicators are classified as preparations for which correct and current indication is of particular importance: antipsychotic drugs (N05A except lithium) and Nonsteroidal Anti-Inflammatory Drugs (NSAIDs). In the present study, a PIM was defined as exposure to at least one of the drugs mentioned among the six quality indicators.
Measured: Index admission (at randomization) and index discharge (duration of index admission, mean days 8.7)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2012 (estimated)
- Study startJan 2012
- Primary completionJun 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cognitive ImpairmentStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 460 participants (actual)
Sponsor and investigators
- Lead sponsor
- Umeå University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hugo Lovheim, Umeå University
- Investigators
- Hugo Lövheim, MD, PhD, Principal investigator, Umeå University, Umeå, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01504672
- Sponsor's protocol ID
- UmU-2011-148-31M
- Status last verified
- Oct 2021
- First submitted
- 3 Jan 2012
- Last updated
- 9 Nov 2021
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Gustafsson M, Sjolander M, Pfister B, Jonsson J, Schneede J, Lovheim H. Pharmacist participation in hospital ward teams and hospital readmission rates among people with dementia: a randomized controlled trial. Eur J Clin Pharmacol. 2017 Jul;73(7):827-835. doi: 10.1007/s00228-017-2249-8. Epub 2017 Apr 8.
PubMed 28391409
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Pharmacist Intervention Study to Reduce Drug-related Problems and Readmissions Among Old People With Dementia
- ClinicalTrials.gov ID
- NCT01504672
- Acronym / sponsor ID
- UmU-2011-148-31M
- Conditions
- Cognitive Impairment
- Keywords
- Drug related problems
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 460 participants (actual)
- Lead sponsor
- Umeå UniversityUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Jun 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 5 Jan 2012 (estimated)
- Results
- Posted 9 Nov 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this randomized controlled study is to investigate if medication reviews performed by a clinical pharmacist as part of a ward team can reduce drug related problems and reduce readmissions to hospital among elderly patients (≥65 years) with dementia and cognitive failure.
Four hundred and sixty patients will be recruited and randomized to control (usual care) and intervention group (enhanced service in which a pharmacist is part of the health care team).
Six months after the last patient of the 460 has been discharged the study will be closed. Data about the number of readmissions and visits to the emergency room will be collected during the six-month follow-up and also, the costs associated with each visit or admission. Time until institutionalization will be compared between intervention group and control group.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Medication review | Experimental | Other: Medication review |
| Usual care | No intervention | – |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Patients with dementia or cognitive impairment
- Patients ≥ 65 years
Key exclusion criteria (1 listed)
- Patients previously admitted to the study wards during the study period
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 |
|---|---|---|
| Medication reviewIn the intervention, the pharmacist will evaluate: * Is there an indication for the drug? * Has the drug desired effect? * Is the dose correct and dosing scheme correct? * Side effects, contraindications, inappropriate drugs * Interactions * Treatment time * Cost effectiveness * Adherence to recommendation list * Problems with handling the drugs (for example crushing of the tablets) * Untreated indication * Double medications * Administration of drugs | Other | Medication review |
Primary outcome
Number of Patients Readmitted Because of Drug Related Reasons
Time frame: Six months follow-up
4 secondary outcomes
Cost for Visits for Readmissions and to the Emergency Department Compared Between Patients in the Control Group and Intervention Group.
Time frame: Six months follow-up
Number of Participants Institutionalized After Discharge, in Control Group and Intervention Group.
Time frame: Six months follow-up
Frequency of Emergency Department Visits During the 6-month Follow-up.
Time frame: Six months follow-up
Change in the Number of Participants With Potentially Inappropriate Medications, According to the Swedish National Board of Health and Welfare, at Admission and Discharge Between Intervention and Control Group
Time frame: Index admission (at randomization) and index discharge (duration of index admission, mean days 8.7)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28391409Gustafsson M, Sjolander M, Pfister B, Jonsson J, Schneede J, Lovheim H. Pharmacist participation in hospital ward teams and hospital readmission rates among people with dementia: a randomized controlled trial. Eur J Clin Pharmacol. 2017 Jul;73(7):827-835. doi: 10.1007/s00228-017-2249-8. Epub 2017 Apr 8.
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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.
Hugo Lövheim, MD, PhD principal investigator
Umeå University, Umeå, Sweden
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medication review in people with Cognitive Impairment, run by Umeå University at 2 sites in Sweden.
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 2 inclusion and 1 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 9 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. 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?
Yes. Results are posted in the registry (first posted 9 Nov 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Patients Readmitted Because of Drug Related Reasons (time frame: Six months follow-up). 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 NCT01504672, which also lists 1 linked publication.
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 9 Nov 2021.