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. 2022 Feb 24;2022(2):CD000313. doi: 10.1002/14651858.CD000313.pub6

Lindpaintner 2013.

Study characteristics
Methods Pilot parallel randomised trial
Participants recruited between September 2008 and December 2009
Participants Patients aged ≥ 18 years who had been admitted to an internal medicine ward, taking oral anticoagulation or newly ordered insulin or more than 8 regular medicines or new diagnosis requiring at least 4 long‐term medicines, expected to live > 1 month, German‐speaking, no cognitive impairment; excluded if PCP or local visiting nurse association not involved in the study
Number of patients recruited: T = 30, C = 30
Mean age (SD): T = 75.1 years (9.49), C = 75.2 (12.4)
Sex (female): T = 15/30 (50%), C = 19/30 (63%)
Interventions Setting: teaching hospital in Baden, Switzerland
Pre‐admission assessment: no
Case finding on admission: all patients admitted to hospital were screened for eligibility
Inpatient assessment and preparation of a discharge plan based on individual patient needs: the nurse care manager assessed patients with a battery of tests
Implementation of the discharge plan: the NCM liaised with the ward team and jointly developed a discharge plan, which included self‐management techniques; the PCP and community nursing team received a copy of the discharge form, as well as a letter at the end of the intervention, and further contacts were done as needed
Monitoring: structured call 24 hours post‐discharge and home visit at the end of the intervention
Control: best usual care (no additional information provided)
Outcomes Composite endpoint (death, re‐hospitalisation, unplanned urgent medical evaluation within 5 days and 30 days of discharge, and adverse medicine reaction requiring discontinuation of the medicine), satisfaction with discharge process, caregiver burden, health‐related quality of life.
The study authors commented that: "the definitions for two components of the primary composite endpoint failed to discriminate sufficiently between adverse events and desirable medical management. Thus planned rehospitalizations and all medicine changes (such as changing a blood pressure medicine) were counted as adverse events even if they reflected medical management decisions unrelated to patient harm." (p.761, 1st column)
Notes Funding: MediService AG, Zuchwil, Switzerland
Conflicts of interest: none reported
Ethical approval: Internal Review Board
Notes: pilot study; insufficient data to be included in the pooled analysis, authors contacted but no further data obtained
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Comment: Block randomisation (p.757)
Allocation concealment (selection bias) Unclear risk Comment: Not reported
Baseline outcome data Low risk Comment: primary composite outcome of death, rehospitalisation, unplanned urgent medical evaluation within 5 days of discharge and adverse medicine reaction requiring dicontinuation of the medicine.
Baseline characteristics similar Low risk Comment: 3 patients allocated to the intervention group were receiving ongoing chemotherapy. A small study of 30 in each group.
Blinding (performance bias and detection bias)
All outcomes High risk Comment: Interview‐based data (patients, nurses, and PCP)
Incomplete outcome data (attrition bias)
All outcomes Low risk Comment: Drop‐outs accounted for, intention‐to‐treat analysis
Study adequately protected against contamination High risk Comment: The same team of physicians and nurses provided inpatient care to both groups (p.759)
Selective reporting (reporting bias) Unclear risk Comment: Not able to judge from available information
Other bias Unclear risk Comment: Not reported