Marusic 2013.
| Study characteristics | ||
| Methods |
Aim of study: to evaluate the effect of hospital pharmacotherapeutic counselling on rates and causes of 30‐day post‐discharge hospital re‐admissions and ED visits Study design: RCT (individual allocation) Number of arms/groups: 2 |
|
| Participants |
Description: patient/consumer Geographic location: Croatia Setting: hospital discharge Inclusion criteria: ≥ 65 years, hospital discharge to community with prescription for ≥ 2 medications for treatment of chronic disease Exclusion criteria: cognitive or perceptual problems, diagnosis of terminal illness with life expectancy < 1 month, discharge to long‐term care facility, inability to be followed up Number of participants randomised: 160 Number of participants included in analysis: 160 (80 and 80) Age: mean ± SD (range): 74.0 ± 6.7 (65 to 88) vs 73.9 ± 5.5 (65 to 87) Gender: female n (%): 43 (53.8%) vs 47 (58.8%) Ethnicity: not specified Number of medications: prescribed medication mean ± SD (range): 6.6 ± 2.4 (2 to 13) vs 6.2 ± 2.6 (2 to 13) Frailty/Functional impairment: not specified Cognitive impairment: cognition problems excluded Comorbidities: number of discharge diagnoses: 4.4 ± 1.6 (1 to 8) vs 3.9 ± 1.5 (2 to 8) |
|
| Interventions |
Group 1 ‐ Pharmacotherapeutic discharge counselling: pre‐discharge counselling (30 minutes) by qualified physician, specialist in clinical pharmacology, provided within 24 hours before discharge. Counselling included indications, dosage and admin times, importance of compliance, possible consequences of non‐compliance, possible ADRs Group 2 ‐ Usual care (including discharge letter to be handed to GP) Co‐intervention: N/A Provider: physician (specialist in clinical pharmacology) Where: hospital When and how often: once within 24 hours of discharge Intervention personalised: yes |
|
| Outcomes |
Timing of outcome assessment: 30 days Medication adherence (objective) : pill count ‐ patients asked to bring all remaining medications and empty packaging to follow‐up visit. Compliance = total number of doses taken by the patient since discharge/total number of doses to be taken since discharge × 100. Reported as percentage of participants who are compliant (80% to 110%). If participants could not attend hospital, then visit was arranged at home Adverse clinical health outcomes (objective): hospital re‐admission/ED visit: number of patients with re‐admission or ED visit Adverse clinical health outcomes (objective): number of patients with ADRs: the probability that an ADR was drug related was estimated using the Naranjo ADR probability scale. ADRs that were fatal or life threatening or required hospital admission were considered serious ADRs |
|
| Notes | Trial registration: N/A Consumer involvement: not specified Funding source: no external funding Dropout: nil mentioned |
|
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Manual shuffle of 80 intervention and 80 control cards in envelopes |
| Allocation concealment (selection bias) | Unclear risk | Sealed, unmarked envelope contained card with 'intervention' or 'control'. Unclear if opaque envelopes |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Patients and physicians were not blinded |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Outcomes assessed by research assistant blinded to treatment assignment |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | No attrition |
| Selective reporting (reporting bias) | Low risk | Reported as per methods |
| Other bias | Low risk | Sample size 80/group |