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. 2020 May 8;2020(5):CD012419. doi: 10.1002/14651858.CD012419.pub2

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
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
Interventions Group 13D (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 2Usual 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
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)
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
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"