Trial Outcomes & Findings for An Intervention Study to Reduce Drug-related Problems and Readmissions Among Old People With Dementia (NCT NCT01504672)
NCT ID: NCT01504672
Last Updated: 2021-11-09
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
460 participants
Primary outcome timeframe
Six months follow-up
Results posted on
2021-11-09
Participant Flow
Participant milestones
| Measure |
Intervention Group
Medication 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
|
Control Group
Usual Care where no medication review is performed by clinical pharmacists
|
|---|---|---|
|
Overall Study
STARTED
|
230
|
230
|
|
Overall Study
COMPLETED
|
212
|
217
|
|
Overall Study
NOT COMPLETED
|
18
|
13
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
An Intervention Study to Reduce Drug-related Problems and Readmissions Among Old People With Dementia
Baseline characteristics by cohort
| Measure |
Intervention Group
n=212 Participants
An intervention as described is performed for the people in the intervention group.
|
Control Group
n=217 Participants
No intervention is performed.
|
Total
n=429 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
212 Participants
n=5 Participants
|
217 Participants
n=7 Participants
|
429 Participants
n=5 Participants
|
|
Age, Continuous
|
83.1 years
STANDARD_DEVIATION 6.6 • n=5 Participants
|
83.1 years
STANDARD_DEVIATION 6.6 • n=7 Participants
|
83.1 years
STANDARD_DEVIATION 6.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
133 Participants
n=5 Participants
|
138 Participants
n=7 Participants
|
271 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
79 Participants
n=5 Participants
|
79 Participants
n=7 Participants
|
158 Participants
n=5 Participants
|
|
Region of Enrollment
Sweden
|
212 participants
n=5 Participants
|
217 participants
n=7 Participants
|
429 participants
n=5 Participants
|
|
Medical history
Heart failure
|
72 participants
n=5 Participants
|
54 participants
n=7 Participants
|
126 participants
n=5 Participants
|
|
Medical history
Hypertension
|
116 participants
n=5 Participants
|
105 participants
n=7 Participants
|
221 participants
n=5 Participants
|
|
Medical history
Cardiac arrhythmia
|
62 participants
n=5 Participants
|
58 participants
n=7 Participants
|
120 participants
n=5 Participants
|
|
Medical history
Diabetes Mellitus
|
61 participants
n=5 Participants
|
47 participants
n=7 Participants
|
108 participants
n=5 Participants
|
|
Medical history
COPD
|
16 participants
n=5 Participants
|
18 participants
n=7 Participants
|
34 participants
n=5 Participants
|
|
Medical history
Malignant disease, past or present
|
27 participants
n=5 Participants
|
20 participants
n=7 Participants
|
47 participants
n=5 Participants
|
|
Medical history
Myocardial infarction
|
36 participants
n=5 Participants
|
25 participants
n=7 Participants
|
61 participants
n=5 Participants
|
|
Medical history
Stroke, past
|
50 participants
n=5 Participants
|
46 participants
n=7 Participants
|
96 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Six months follow-upOutcome measures
| Measure |
Intervention Group
n=212 Participants
Medication 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
|
Control Group
n=217 Participants
Usual Care where no medication review is performed by clinical pharmacists
|
|---|---|---|
|
Number of Patients Readmitted Because of Drug Related Reasons
|
40 Participants
|
50 Participants
|
SECONDARY outcome
Timeframe: Six months follow-upTo evaluate the economic impact of clinical pharmacist engagement in hospital ward teams for medication therapy management in older patients with dementia or cognitive impairments.
Outcome measures
| Measure |
Intervention Group
n=212 Participants
Medication 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
|
Control Group
n=217 Participants
Usual Care where no medication review is performed by clinical pharmacists
|
|---|---|---|
|
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
|
2630 Euro
Standard Deviation 0
|
SECONDARY outcome
Timeframe: Six months follow-upPopulation: 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.
Outcome measures
| Measure |
Intervention Group
n=146 Participants
Medication 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
|
Control Group
n=158 Participants
Usual Care where no medication review is performed by clinical pharmacists
|
|---|---|---|
|
Number of Participants Institutionalized After Discharge, in Control Group and Intervention Group.
|
17 Participants
|
24 Participants
|
SECONDARY outcome
Timeframe: Six months follow-upOutcome measures
| Measure |
Intervention Group
n=212 Participants
Medication 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
|
Control Group
n=217 Participants
Usual Care where no medication review is performed by clinical pharmacists
|
|---|---|---|
|
Frequency of Emergency Department Visits During the 6-month Follow-up.
|
190 All-cause emergency department visits
|
184 All-cause emergency department visits
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Intervention Group
n=212 Participants
Medication 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
|
Control Group
n=217 Participants
Usual Care where no medication review is performed by clinical pharmacists
|
|---|---|---|
|
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
|
5 Participants
|
POST_HOC outcome
Timeframe: 30 daysTime from discharge to drug-related readmission among the whole sample, post-hoc
Outcome measures
| Measure |
Intervention Group
n=212 Participants
Medication 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
|
Control Group
n=217 Participants
Usual Care where no medication review is performed by clinical pharmacists
|
|---|---|---|
|
Time From Discharge to Drug-related Readmission
|
29.1 days
Standard Deviation 0.30
|
28.1 days
Standard Deviation 0.43
|
Adverse Events
Intervention Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place