NCT04263233

Evaluation of the Optimal Transition Program

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 20 (estimated)
• Sponsor: Satellite Healthcare · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an evaluation of a program developed by a team of nephrologists, operations experts and researchers. The goal is to provide CKD patients with a better way to transition to life on dialysis - one that emphasizes even more individual clinical, psychosocial and lifestyle needs. On top of high-quality clinical care, the 4-week Optimal Transition program supports patients as they adjust to treatment and learn to live the best life possible. This is done through a robust education curriculum and a trust-building approach.

Detailed description

In this program evaluation the investigators will be reporting on the following program outcomes: 1. Clinical and psychosocial stabilization: to include lab values, clinical dialysis parameters, patient-reported symptoms, quality of life, hospitalization and mortality rates. 2. Dialysis modality choice with satisfaction with the modality education and continued modality use over 24 months. 3. Patient knowledge, activation, and satisfaction. 4. Program parameters such as time, costs, referral rate, admissions and length of stay within the program.

Conditions

• ESRD
• Hemodialysis

Interventions

Type	Name	Description
OTHER	Analysis using descriptive statistics of patient clinical outcomes.	Evaluation of the following: * Laboratory values at admission, week 4, and day 90. * Pre and post blood pressure at week one and week 4. * Intradialytic hypotension at week one and week 4. * Ultrafiltration rates at week one, week 4, day 90, day 180, and day 360. * Target weight defined and achievement in week one and week 4 and changes between week one and week 4. * Dialysis access type at week one and day 90. * Hospitalization and mortality rates.
OTHER	Surveys with participants using validated survey tools.	Surveys will assess participants' Symptom index, Quality of Life, Patient Activation as well as satisfaction with the program.
OTHER	Evaluation of the program process including time, costs, referral rates, admission to the program and length of stay.	Data will be collected using tracking tools throughout the program.

Timeline

• Start date: 2020-01-29
• Primary completion: 2022-07-28
• Completion: 2022-12-31
• First posted: 2020-02-10
• Last updated: 2021-09-22

Locations

3 sites across 1 country: United States