Evaluation of the Optimal Transition Program
1 other identifier
observational
20
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jan 2020
Typical duration for all trials
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 29, 2020
CompletedFirst Submitted
Initial submission to the registry
February 5, 2020
CompletedFirst Posted
Study publicly available on registry
February 10, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 28, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2022
CompletedSeptember 22, 2021
September 1, 2021
2.5 years
February 5, 2020
September 21, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (20)
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
Study Arms (1)
Other
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.
Interventions
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.
Surveys will assess participants' Symptom index, Quality of Life, Patient Activation as well as satisfaction with the program.
Data will be collected using tracking tools throughout the program.
Eligibility Criteria
All patients referred by their treating nephrologist to one of the two Satellite Healthcare (SHC) participating centers who are new to dialysis and meet the inclusion/exclusion criteria.
You may qualify if:
- 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).
You may not qualify if:
- Unable to meaningfully interact with staff;
- Unable to read and understand English; or
- Has significant cognitive impairment per the nephrologist or Principal Investigator
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Satellite Healthcare Oakland
Oakland, California, 94609, United States
Satellite Healthcare Sacramento
Sacramento, California, 95834, United States
Satellite Healthcare Chickasaw Gardens
Memphis, Tennessee, 38111, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Wael F Hussein, MBBS
Satellite Healthcare, Inc.
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- OTHER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 5, 2020
First Posted
February 10, 2020
Study Start
January 29, 2020
Primary Completion
July 28, 2022
Study Completion
December 31, 2022
Last Updated
September 22, 2021
Record last verified: 2021-09
Data Sharing
- IPD Sharing
- Will not share