Cognitive Impairment
Conditions
Keywords
Drug related problems
Brief 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. 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.
Interventions
OTHERMedication review
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
Sponsors
Umeå University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with dementia or cognitive impairment * Patients ≥ 65 years
Exclusion criteria
* Patients previously admitted to the study wards during the study period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Patients Readmitted Because of Drug Related Reasons | Six months follow-up |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cost for Visits for Readmissions and to the Emergency Department Compared Between Patients in the Control Group and Intervention Group. | Six months follow-up | 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. |
| 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 | Index admission (at randomization) and index discharge (duration of index admission, mean days 8.7) | 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. |
Countries
Sweden
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intervention Group An intervention as described is performed for the people in the intervention group. | 212 |
| Control Group No intervention is performed. | 217 |
| Total | 429 |
Baseline characteristics
| Characteristic | Intervention Group | Control Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 212 Participants | 217 Participants | 429 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 83.1 years STANDARD_DEVIATION 6.6 | 83.1 years STANDARD_DEVIATION 6.6 | 83.1 years STANDARD_DEVIATION 6.6 |
| Medical history Cardiac arrhythmia | 62 participants | 58 participants | 120 participants |
| Medical history COPD | 16 participants | 18 participants | 34 participants |
| Medical history Diabetes Mellitus | 61 participants | 47 participants | 108 participants |
| Medical history Heart failure | 72 participants | 54 participants | 126 participants |
| Medical history Hypertension | 116 participants | 105 participants | 221 participants |
| Medical history Malignant disease, past or present | 27 participants | 20 participants | 47 participants |
| Medical history Myocardial infarction | 36 participants | 25 participants | 61 participants |
| Medical history Stroke, past | 50 participants | 46 participants | 96 participants |
| Region of Enrollment Sweden | 212 participants | 217 participants | 429 participants |
| Sex: Female, Male Female | 133 Participants | 138 Participants | 271 Participants |
| Sex: Female, Male Male | 79 Participants | 79 Participants | 158 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 212 | 0 / 217 |
| serious Total, serious adverse events | 0 / 212 | 0 / 217 |
Outcome results
Primary
Number of Patients Readmitted Because of Drug Related Reasons
Time frame: Six months follow-up
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention Group | Number of Patients Readmitted Because of Drug Related Reasons | 40 Participants |
| Control Group | Number of Patients Readmitted Because of Drug Related Reasons | 50 Participants |
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.
Time frame: Index admission (at randomization) and index discharge (duration of index admission, mean days 8.7)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention Group | 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 | 13 Participants |
| Control Group | 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 | 5 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.
Time frame: Six months follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group | Cost for Visits for Readmissions and to the Emergency Department Compared Between Patients in the Control Group and Intervention Group. | 2340 Euro | Standard Deviation 0 |
| Control Group | Cost for Visits for Readmissions and to the Emergency Department Compared Between Patients in the Control Group and Intervention Group. | 2630 Euro | Standard Deviation 0 |
Secondary
Frequency of Emergency Department Visits During the 6-month Follow-up.
Time frame: Six months follow-up
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention Group | Frequency of Emergency Department Visits During the 6-month Follow-up. | 190 All-cause emergency department visits |
| Control Group | Frequency of Emergency Department Visits During the 6-month Follow-up. | 184 All-cause emergency department visits |
Secondary
Number of Participants Institutionalized After Discharge, in Control Group and Intervention Group.
Time frame: Six months follow-up
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention Group | Number of Participants Institutionalized After Discharge, in Control Group and Intervention Group. | 17 Participants |
| Control Group | Number of Participants Institutionalized After Discharge, in Control Group and Intervention Group. | 24 Participants |
Post Hoc
Time From Discharge to Drug-related Readmission
Time from discharge to drug-related readmission among the whole sample, post-hoc
Time frame: 30 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group | Time From Discharge to Drug-related Readmission | 29.1 days | Standard Deviation 0.3 |
| Control Group | Time From Discharge to Drug-related Readmission | 28.1 days | Standard Deviation 0.43 |