Methods |
Study design: RCT; 186 assessed for eligibility,160 participants randomised
Study duration: 6 weeks
Study follow‐up: 12 weeks
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Participants |
Country: China
Setting: community, dialysis unit
Maintenance PD patients
Number (randomised/completed): intervention group (80/69); control group (80/66)
Mean age ± SD (years): intervention group (57.4 ± 12.8); control group (55.2 ± 11.9)
Sex (M/F): intervention group (42/27); control group (37/29)
Exclusion criteria: Tenchkoff catheters in situ for less than 3 months; receiving intermittent PD or HD and those with planned admissions for special treatment procedures; psychosis or dementia; dying or unable to communicate; being transferred to another unit during their hospital stay
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Interventions |
Intervention group
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Telephone support
Comprehensive discharge planning protocol prior to discharge and standardised 6‐week post‐discharge nurse‐led telephone support intervention
Patients physical, social, cognitive and emotional needs assessed and comprehensively and individualised education program conducted prior to discharge
After discharge nurse case managers began telephone contact with patients weekly for 6 consecutive weeks. First call within first 72 hours after discharge to assess status and give advice
Content of each telephone call guided by the protocol and specific problems identified in predischarge assessment
Case manager discussed issues patients encountered and if necessary made appropriate referrals
Control group
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Standard care
Talking to doctor about special points that need attention when returning home
Telephone hotline service
Set of free self‐help printed materials on maintaining healthy lifestyle
Reminder to attend outpatient appointments
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Outcomes |
QoL: KDQoL‐SF (baseline, 6 weeks, 12 weeks)
Complications (oedema, weight gain, peritonitis, catheter infections, biochemistry (urea, creatinine, sodium, K, PO4, albumin), self reported and validated against hospital records (measured weeks 6‐12)
Healthcare utilisation: self reported and hospital records (days between index discharge and readmission were extracted from the hospital information systems) (measured weeks 6‐12)
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Notes |
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Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Low risk |
Computer generated numbers |
Allocation concealment (selection bias) |
Unclear risk |
Insufficient information to permit judgement |
Blinding of participants and personnel (performance bias)
Blinding of participants |
High risk |
Unable to be blinded |
Blinding of participants and personnel (performance bias)
Blinding of personnel |
Unclear risk |
No mention but probably not blinded because of nature of intervention |
Blinding of outcome assessment (detection bias)
Objective outcome |
Low risk |
Hospital records are objective |
Blinding of outcome assessment (detection bias)
Subjective outcomes |
Unclear risk |
No mention of whether blinded, some measures (QoL) used validated measures, while others (health service utilisation) was self‐reported |
Incomplete outcome data (attrition bias)
All outcomes |
Unclear risk |
Dropout (13.7% to 17.5%), no mention of whether these drop outs significantly different; only those with full outcome data included in study; reasons for drop outs similar across both groups |
Selective reporting (reporting bias) |
High risk |
Insufficient information to permit judgement |
Other bias |
High risk |
Small sample size, short duration ‐ not generalisable under powered |