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Evaluation of the Optimal Transition Program

Evaluation of the Optimal Transition Program

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04263233
Enrollment
20
Registered
2020-02-10
Start date
2020-01-29
Completion date
2022-12-31
Last updated
2021-09-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ESRD, Hemodialysis

Keywords

ESRD, Hemodialysis, Education, Evaluation

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.

Interventions

OTHERAnalysis 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.

OTHERSurveys with participants using validated survey tools.

Surveys will assess participants' Symptom index, Quality of Life, Patient Activation as well as satisfaction with the program.

OTHEREvaluation 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.

Sponsors

Satellite Healthcare
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Evaluation of clinical stabilization through standard clinical dialysis labsOn admission, week 4 and day 90Evaluation of changes in the Standard of care monthly dialysis labs
Evaluation of clinical stabilization through standard clinical dialysis blood pressure measurementsAt 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 pressuresAt 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 ultrafiltrationAt 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 weightAt 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 measurementsAt week one and day 90Dialysis 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 monthsHospitalization 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 monthsMortality rates as reported in the standard dialysis record for all patients
Evaluation of clinical and psychological stabilization through a quality of life measurement.Week 4The EQ-5D tool will be used
Evaluation of clinical and psychological stabilization through assessment of patient symptoms.Week 1 and Week 4The ESAS-r:Renal tool will be used
Satisfaction with the modality options educationWeek 1 and Week 4Survey of patient experience
Type of Dialysis Modality chosen by the patientWeek 1 and Week 4Dialysis modality choice as reported by the patient
Actual Type of Dialysis Modality used by the patientweek 4, month 3, 6, 12, 18 and 24Dialysis modality as reported on the standard dialysis treatment sheets
Evaluation of patient knowledge of dialysis and modalitiesWeek 1, 2, 3, 4Weekly 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 activationWeek 3 and month 3Survey measuring patient activation (PAM-13) survey
Evaluation of patient satisfactionWeek 4 or discharge from the program whichever comes firstSurvey of satisfaction with the program
Evaluation of the program process for time utilizationWeek 1 through week 4Time per patient for visits from program start to completion for each patient
Evaluation of the program process for cost utilizationWeek 1 through week 4Time, 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 programWeek 1 through week 4Number of referrals to the program and subsequent number of admissions to the program.
Evaluation of the program efficiencyWeek 1 through week 4Average length of stay for each patient in the program.

Countries

United States

Contacts

Primary ContactJug Atwal
atwalJ@satellitehealth.com650-404-3606
Backup ContactLegg Veronica, M.S.
leggv@satellitehealth.com650-404-3736

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026