Manning 2007.
Study characteristics | ||
Methods |
Aim of study: to determine whether the 3D tool is better than the Medication Discharge Worksheet in terms of patient satisfaction, understanding, and safety Study design: RCT (exploratory RCT; 4 medical units; individual allocation) Number of arms/groups: 2 |
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Participants |
Description: patient/consumer Geographic location: USA Setting: hospital discharge Inclusion criteria: > 20 years, ≥ 3 discharge medications, returning to self‐care at home (or to care of a relative) Exclusion criteria: discharge to nursing home, hospital, or assisted living facility; unable to speak or read English; unable to hear over the telephone to participate in follow‐up; pregnant Number of participants randomised: 337 Number of participants included in analysis: 138 (78 and 60) Age: mean ± SD 68.1 ± 5.65 intervention vs 67.6 ± 13.06 control (total range 24 to 100) Gender: unclear: % or mean (SD): Table 1: 0.51 ± 0.50 vs 0.38 ± 0.49 Ethnicity: not specified Number of medications: not specified (discharge medications): 10.0 ± 4.42 vs 8.7 ± 3.93 (total range 4 to 31) Frailty/Functional impairment: not specified Cognitive impairment: not specified Comorbidities: not specified |
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Interventions |
Group 1 ‐ 3D (durable display at discharge) medication discharge education tool: 3D tool including purpose, time to take medications, comments and cautions, and space for durable display (patients encouraged to affix tablet/capsule of each medication onto the 3D tool in column labelled "Display"). Plus a section for "home medications you should no longer take". Participants randomised to 3D upon returning home and after filling any new prescriptions were encouraged to affix (with clear adhesive tape) a tablet or capsule of each medication onto the 3D adjacent to the medication name and under the column labelled "Display" Group 2 ‐ Usual care ‐ medication discharge worksheet (MDW) Co‐intervention: before hospital dismissal, the primary nurse conducted her/his usual patient education session including usage of either MDW or 3D (per randomisation) Provider: 3D medication sheets (generated by study recruiter, reviewed by principal investigator or pharmacist co‐investigator. Nurse provided patient education) Where: hospital discharge When and how often: once Intervention personalised: yes |
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Outcomes |
Timing of outcome assessment: 7 to 14 days after discharge Medication taking ability (subjective) : self‐reported safety in taking medications: "since discharge, how many mistakes have you made taking your medications (score 0‐4)?" Knowledge about medicines (objective): assessment of knowledge of indication, dosage frequency, and special comments or cautions: 0 (for no correct responses) to 3 (all correct responses) Satisfaction with intervention (subjective): how satisfied were you with the form you received from the nurse when she/he was talking to you about your medications? 5‐point Likert scale: 1 (low) to 5 (high) |
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Notes | Trial registration: N/A Consumer involvement: not specified Funding source: Mayo Clinic Rochester MIDAS Grant; Mayo Foundation for Education and Research, small grants programme Dropout: 38 (did not remember form ‐ so were not interviewed), 126 lost to follow‐up (93 could not be reached, 12 excluded post discharge, 4 could not hear during call, 5 incorrect phone number, 2 did not receive MDW, 5 too ill, 4 refused, 1 no English) Fidelity: compliance with affixing medications to 3D is uncertain |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated random number algorithm |
Allocation concealment (selection bias) | Unclear risk | Not specified |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Not possible to blind |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Research assistant conducting follow‐up call was blinded to both study hypotheses and participant randomisation |
Incomplete outcome data (attrition bias) All outcomes | High risk | Loss to follow‐up high. 176/337 randomised were contacted by telephone, 38 did not remember the tool so were excluded from analysis, only 41% of randomised patients (138/337) were included in analysis. No statistically significant differences in patient loss at each level |
Selective reporting (reporting bias) | Low risk | Hypotheses and outcomes listed as per methods |
Other bias | Unclear risk | "Patient compliance with affixing medications to 3D is uncertain" ‐ "analysed on intention‐to‐influence basis with knowledge that any non‐compliance might diminish the apparent 3D benefit" |