Transplant Trial Watch

Telemedically-supported case management of living-donor renal transplant recipients to optimize routine evidence-based aftercare: A single-center randomized controlled trial.

Schmid A, Hils S, et al.

American Journal of Transplantation 2016 [record in progress]


Aims
To assess the effectiveness of standard aftercare versus telemedically supported case management in improving long-term outcomes among living-donor renal transplant recipients.

Interventions
Participants were randomised to receive either standard care, versus interventional aftercare consisting of telemedically supported case management.

Participants
46 adult living-donor renal transplant recipients.

Outcomes
The primary outcome measured was unplanned admission rate, and the secondary outcome measured was the length of unplanned stay. Other outcomes measured included unplanned patient care costs, rejection rate, length of time prior to rejection therapy initiation, estimated glomerular filtration rate, ambulatory care visit rate, composite adherence score and percentage grade, quality of life scores and working time percentage.

Follow-up
1 year

CET Conclusions
This trial compared a standard aftercare programme combined with telemedically-supported case management with standard aftercare alone for 46 living-donor renal transplant recipients during their first year posttransplant. Patients were randomised using a computer-generated randomisation sequence with allocation concealment. Telemedically-supported case management consisted of initiation of chronic care case management after discharge, case management in acute care situations, and a telemedically equipped team comprising a transplant nurse case manager and two senior transplant physicians (nephrologist and surgeon). The primary outcome was the unplanned admission rate and the sensitivity power analysis showed that 46 participants were needed to provide 80% power. The intention-to-treat analysis revealed that the intervention group showed significantly lower admission rates and shorter lengths of unplanned hospitalisation at 12 months and better adherence to the immunosuppressive regimen. Clinical outcomes were assessed but the incidences were too low for meaningful comparison.

Jadad score
3

Data analysis
Strict intention-to-treat analysis

Allocation concealment
Yes

Trial registration
German Clinical Trials Register - DKRS00007634

Funding source
Industry & non-industry funded