Evaluation of the Optimal Transition Program

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

Official Title
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Evaluation of the Optimal Transition Program

Conditions
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ESRD, Hemodialysis

Intervention / Treatment
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* Other: Analysis using descriptive statistics of patient clinical outcomes.
* Other: Surveys with participants using validated survey tools.
* Other: Evaluation of the program process including time, costs, referral rates, admission to the program and length of stay.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Referred for incenter hemodialysis at one of two Satellite Healthcare (SHC) participating dialysis units Without significant cognitive impairment; Able to meaningfully interact with staff; and Fluent in English (due to education material being limited to English at this time). Exclusion Criteria: Unable to meaningfully interact with staff; Unable to read and understand English; or Has significant cognitive impairment per the nephrologist or Principal Investigator

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other<br>This program, which is provided for all patients new to dialysis at the participating units, will be evaluated by assessing patient clinical outcomes and the results of surveys measuring patient-reported symptoms, quality of life, knowledge and activation. In addition, satisfaction with the program will be assessed. | Other: Analysis using descriptive statistics of patient clinical outcomes.<br>* 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.<br>Other: Surveys with participants using validated survey tools.<br>* Surveys will assess participants' Symptom index, Quality of Life, Patient Activation as well as satisfaction with the program.<br>Other: Evaluation of the program process including time, costs, referral rates, admission to the program and length of stay.<br>* Data will be collected using tracking tools throughout the program.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of clinical stabilization through standard clinical dialysis labs | Evaluation of changes in the Standard of care monthly dialysis labs | On admission, week 4 and day 90 | 
| Evaluation of clinical stabilization through standard clinical dialysis blood pressure measurements | Evaluation of any changes in the Pre and post dialysis blood pressures for each patient which are collected as part of the patient's dialysis flow sheet. | At week one and week 4. | 
| Evaluation of clinical stabilization through standard clinical dialysis measurements of Intradialytic blood pressures | Evaluation of any changes in the incidence of Intradialytic hypotension as assessed by review of the patient's dialysis flow sheet. | At week one and week 4. | 
| Evaluation of clinical stabilization through standard clinical dialysis measurements of ultrafiltration | Evaluation of interval changes in the patient's ultrafiltration rates as measured by the dialysis machine and reported on the patient's dialysis flow sheets. | At week one, week 4, day 90, day 180 and day 360. | 
| Evaluation of clinical stabilization through standard clinical dialysis measurements of weight | Target weight defined and achieved as measured by standard of care at the unit | At week one and week 4, and changes between week one and week 4. | 
| Evaluation of clinical stabilization through standard clinical dialysis measurements | Dialysis access type as reported in the dialysis treatment sheets | At week one and day 90 | 
| Evaluation of clinical stabilization through standard clinical dialysis collection of patient hospitalizations. | Hospitalization rates as reported in the standard dialysis record for all patients | Day 30, day 90, 6 months and 12 months | 
| Evaluation of clinical stabilization through standard clinical dialysis records. | Mortality rates as reported in the standard dialysis record for all patients | Day 30, day 90, 6 months and 12 months | 
| Evaluation of clinical and psychological stabilization through a quality of life measurement. | The EQ-5D tool will be used | Week 4 | 
| Evaluation of clinical and psychological stabilization through assessment of patient symptoms. | The ESAS-r:Renal tool will be used | Week 1 and Week 4 | 
| Satisfaction with the modality options education | Survey of patient experience | Week 1 and Week 4 | 
| Type of Dialysis Modality chosen by the patient | Dialysis modality choice as reported by the patient | Week 1 and Week 4 | 
| Actual Type of Dialysis Modality used by the patient | Dialysis modality as reported on the standard dialysis treatment sheets | week 4, month 3, 6, 12, 18 and 24 | 
| Evaluation of patient knowledge of dialysis and modalities | Weekly focused one on one discussion where the patient is questioned about his/her understanding of dialysis, his/her progress, questions, concerns using a questionnaire developed by the investigator | Week 1, 2, 3, 4 | 
| Evaluation of patient activation | Survey measuring patient activation (PAM-13) survey | Week 3 and month 3 | 
| Evaluation of patient satisfaction | Survey of satisfaction with the program | Week 4 or discharge from the program whichever comes first | 
| Evaluation of the program process for time utilization | Time per patient for visits from program start to completion for each patient | Week 1 through week 4 | 
| Evaluation of the program process for cost utilization | Time, and thus cost, for personnel to complete the program with each patient from entrance to completion or early termination. | Week 1 through week 4 | 
| Evaluation of the feasibility of the program | Number of referrals to the program and subsequent number of admissions to the program. | Week 1 through week 4 | 
| Evaluation of the program efficiency | Average length of stay for each patient in the program. | Week 1 through week 4 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ESRD, Hemodialysis, Education, Evaluation