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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Medication review | Experimental |
| |
| Usual care | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Medication review | Other | In the intervention, the pharmacist will evaluate:
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients Readmitted Because of Drug Related Reasons | Six months follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Six months follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hugo Lövheim, MD, PhD | Umeå University, Umeå, Sweden | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| County hospital of Skellefteå | Skellefteå | 931 86 | Sweden | |||
| Umeå University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28391409 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention Group | Medication review: In the intervention, the pharmacist will evaluate:
|
| FG001 | Control Group | Usual Care where no medication review is performed by clinical pharmacists |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention Group | An intervention as described is performed for the people in the intervention group. |
| BG001 | Control Group | No intervention is performed. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Patients Readmitted Because of Drug Related Reasons | Posted | Number | Participants | Six months follow-up |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention Group | Medication review: In the intervention, the pharmacist will evaluate:
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Maria Gustafsson | Umeå University | 0046703978717 | maria.gustafsson@umu.se |
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| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000090143 | Medication Review |
| ID | Term |
|---|---|
| D008509 | Medication Systems |
| D009934 | Organization and Administration |
| D006298 | Health Services Administration |
| D010346 | Patient Care Management |
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|
| Number of Participants Institutionalized After Discharge, in Control Group and Intervention Group. |
| Six months follow-up |
| Frequency of Emergency Department Visits During the 6-month Follow-up. | 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. | Index admission (at randomization) and index discharge (duration of index admission, mean days 8.7) |
| Umeå |
| 901 85 |
| Sweden |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Medical history | Number | participants |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | Euro | Six months follow-up |
|
|
|
| Secondary | Number of Participants Institutionalized After Discharge, in Control Group and Intervention Group. | Of the 460 people included in this study, 31 deceased before discharge. Of the remaining 429 persons, 146+158=304 persons lived at home, and these were included in the analysis. The remaining 125 were already living in nursing homes and were not included in the analysis. | Posted | Count of Participants | Participants | Six months follow-up |
|
|
|
| Secondary | Frequency of Emergency Department Visits During the 6-month Follow-up. | Posted | Number | All-cause emergency department visits | Six months follow-up |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | Index admission (at randomization) and index discharge (duration of index admission, mean days 8.7) |
|
|
|
| Post-Hoc | Time From Discharge to Drug-related Readmission | Time from discharge to drug-related readmission among the whole sample, post-hoc | Posted | Mean | Standard Deviation | days | 30 days |
|
|
|
| 0 |
| 212 |
| 0 |
| 212 |
| EG001 | Control Group | Usual Care where no medication review is performed by clinical pharmacists | 0 | 217 | 0 | 217 |
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