Evaluation of the Optimal Transition Program
- Conditions
- HemodialysisESRD
- Interventions
- 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.
- Registration Number
- NCT04263233
- Lead Sponsor
- Satellite Healthcare
- Brief 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 20
- 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).
- Unable to meaningfully interact with staff;
- Unable to read and understand English; or
- Has significant cognitive impairment per the nephrologist or Principal Investigator
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Other Evaluation of the program process including time, costs, referral rates, admission to the program and length of stay. 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. 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 Surveys with participants using validated survey tools. 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.
- Primary Outcome Measures
Name Time Method Evaluation of clinical stabilization through standard clinical dialysis labs On admission, week 4 and day 90 Evaluation of changes in the Standard of care monthly dialysis labs
Evaluation of clinical stabilization through standard clinical dialysis blood pressure measurements At week one and week 4. 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.
Evaluation of clinical stabilization through standard clinical dialysis measurements of Intradialytic blood pressures At week one and week 4. Evaluation of any changes in the incidence of Intradialytic hypotension as assessed by review of the patient's dialysis flow sheet.
Evaluation of clinical stabilization through standard clinical dialysis measurements of ultrafiltration At week one, week 4, day 90, day 180 and day 360. 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.
Evaluation of clinical stabilization through standard clinical dialysis measurements of weight At week one and week 4, and changes between week one and week 4. Target weight defined and achieved as measured by standard of care at the unit
Evaluation of clinical stabilization through standard clinical dialysis measurements At week one and day 90 Dialysis access type as reported in the dialysis treatment sheets
Evaluation of clinical stabilization through standard clinical dialysis collection of patient hospitalizations. Day 30, day 90, 6 months and 12 months Hospitalization rates as reported in the standard dialysis record for all patients
Evaluation of clinical stabilization through standard clinical dialysis records. Day 30, day 90, 6 months and 12 months Mortality rates as reported in the standard dialysis record for all patients
Evaluation of clinical and psychological stabilization through a quality of life measurement. Week 4 The EQ-5D tool will be used
Evaluation of clinical and psychological stabilization through assessment of patient symptoms. Week 1 and Week 4 The ESAS-r:Renal tool will be used
Satisfaction with the modality options education Week 1 and Week 4 Survey of patient experience
Type of Dialysis Modality chosen by the patient Week 1 and Week 4 Dialysis modality choice as reported by the patient
Actual Type of Dialysis Modality used by the patient week 4, month 3, 6, 12, 18 and 24 Dialysis modality as reported on the standard dialysis treatment sheets
Evaluation of patient knowledge of dialysis and modalities Week 1, 2, 3, 4 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
Evaluation of patient activation Week 3 and month 3 Survey measuring patient activation (PAM-13) survey
Evaluation of patient satisfaction Week 4 or discharge from the program whichever comes first Survey of satisfaction with the program
Evaluation of the program process for time utilization Week 1 through week 4 Time per patient for visits from program start to completion for each patient
Evaluation of the program process for cost utilization Week 1 through week 4 Time, and thus cost, for personnel to complete the program with each patient from entrance to completion or early termination.
Evaluation of the feasibility of the program Week 1 through week 4 Number of referrals to the program and subsequent number of admissions to the program.
Evaluation of the program efficiency Week 1 through week 4 Average length of stay for each patient in the program.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (3)
Satellite Healthcare Oakland
🇺🇸Oakland, California, United States
Satellite Healthcare Chickasaw Gardens
🇺🇸Memphis, Tennessee, United States
Satellite Healthcare Sacramento
🇺🇸Sacramento, California, United States