Table 1 Primary and secondary outcomes
Primary outcome: Medication Appropriateness Index (MAI) | ||
Number | Item | Weighted score [34] |
1 | Is there an indication for the drug? | 3 |
2 | Is the medication effective for the condition? | 3 |
3 | Is the dosage correct? | 2 |
4 | Are the directions correct? | 2 |
5 | Are the directions practical? | 2 |
6 | Are there clinically significant drug-drug interactions? | 2 |
7 | Are there clinically significant drug-disease/condition interactions? | 1 |
8 | Is there unnecessary duplication with other drugs? | 1 |
9 | Is the duration of the therapy acceptable? | 1 |
10 | Is this drug the least expensive alternative compared to others of equal utility? | 1 |
Range of the MAI sum-score per drug: 0 (fully appropriate) – 18 (fully inappropriate) | ||
MAI-Sum per NHR (dependent on the number of drugs): summation of the weighted MAI sum-scores per drug | ||
MAI-Mean (independent on the number of drugs): division of MAI-Sum by the number of drugs; range 0–18 | ||
Mean difference (“mean MAI change”): mean difference [28] of MAI-Sum between times of measurement | ||
Secondary outcomes | ||
Outcome | Measuring method | Description of measuring method |
Cognitive performance | Mini Mental State Examination (MMSE) [35] Dementia Screening Scale (DSS) [36] | Direct testing of patients; < 25 points → cognitive impairment (range 0–30) Proxy-tool, answering of questions related to the patient by nurses; ≥3 points → cognitive impairment (range 0–14) |
Clinical signs of delirium | Delirium Observation Screening Scale (DOS) [37] | Proxy-tool, screening instrument for identifying risk patients; ≥3 points → delirium presumable (range 0–13) |
Agitation if MMSE < 18 (moderate - severe cognitive impairment) [38] | Cohen Mansfield Agitation Inventory (CMAI-D) [39] | Proxy-tool, related to resident’s behavior in last 2 weeks; four dimensions (physically/verbally aggressive, physically/verbally not aggressive) plus additional item apathy |
Mobility/tendency of falls | Timed Get Up and Go test (TUG) [40] | Walking test of patients; ≥10 s. → impaired mobility |
Number of drugs | Electronic health records of NHs | Total number of prescribed drugs |
Number of severe DDIs | UpToDate [41] | Severe DDIs = category X |
Appropriateness of recorded analgesics | Medication Appropriateness Index (MAI) [33] | MAI-Sum and MAI-Mean were calculated as for the primary endpoint but only including prescribed analgesics (ATC classes M01, N02A, N02B) |