ESRDNCT04263233
Evaluation of the Optimal Transition Program
An observational study of ESRD and Hemodialysis, run by Satellite Healthcare at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ESRD, Hemodialysis
- What is being tested?
- Analysis using descriptive statistics of patient clinical outcomes., Surveys with participants using validated survey tools. and Evaluation of the program process including time, costs, referral rates, admission to the program and length of stay.
- How many people
- 20 participants
- Where
- 3 sitesUnited States
- Study dates
- 29 Jan 2020to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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).
Who cannot join
- Unable to meaningfully interact with staff;
- Unable to read and understand English; or
- Has significant cognitive impairment per the nephrologist or Principal Investigator
Trial locations and contacts
3 sites in 1 country.
United States3 sites, 3 recruiting
- Recruiting
Satellite Healthcare Chickasaw Gardens
Memphis, Tennessee, 38111
- Recruiting
Satellite Healthcare Oakland
Oakland, California, 94609
- Recruiting
Satellite Healthcare Sacramento
Sacramento, California, 95834
About this study
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.
Read the detailed description
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.
- Conditions
- ESRD, Hemodialysis
- Being tested
- Analysis using descriptive statistics of patient clinical outcomes., Surveys with participants using validated survey tools., Evaluation of the program process including time, costs, referral rates, admission to the program and length of stay.
- Keywords
- ESRD, Hemodialysis, Education, Evaluation
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Analysis using descriptive statistics of patient clinical outcomes.Other
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 with participants using validated survey tools.Other
Surveys will assess participants' Symptom index, Quality of Life, Patient Activation as well as satisfaction with the program.
Evaluation of the program process including time, costs, referral rates, admission to the program and length of stay.Other
Data will be collected using tracking tools throughout the program.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of clinical stabilization through standard clinical dialysis labs
Evaluation of changes in the Standard of care monthly dialysis labs
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Week 4
Evaluation of clinical and psychological stabilization through assessment of patient symptoms.
The ESAS-r:Renal tool will be used
Measured: Week 1 and Week 4
Satisfaction with the modality options education
Survey of patient experience
Measured: Week 1 and Week 4
Type of Dialysis Modality chosen by the patient
Dialysis modality choice as reported by the patient
Measured: Week 1 and Week 4
Actual Type of Dialysis Modality used by the patient
Dialysis modality as reported on the standard dialysis treatment sheets
Measured: 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
Measured: Week 1, 2, 3, 4
Evaluation of patient activation
Survey measuring patient activation (PAM-13) survey
Measured: Week 3 and month 3
Evaluation of patient satisfaction
Survey of satisfaction with the program
Measured: 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
Measured: 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.
Measured: 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.
Measured: Week 1 through week 4
Evaluation of the program efficiency
Average length of stay for each patient in the program.
Measured: Week 1 through week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2020
- Study start29 Jan 2020
- Primary completion28 Jul 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ESRDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Satellite Healthcare
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wael F Hussein, MBBS, Principal investigator, Satellite Healthcare, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04263233
- Sponsor's protocol ID
- SIH124_Optional Transition
- Status last verified
- Sep 2021
- First submitted
- 5 Feb 2020
- Last updated
- 22 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Optimal Transition Program
- ClinicalTrials.gov ID
- NCT04263233
- Acronym / sponsor ID
- SIH124_Optional Transition
- Conditions
- ESRD, Hemodialysis
- Keywords
- ESRD, Hemodialysis, Education, Evaluation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Satellite HealthcareUniversity, hospital or other
- Study start
- 29 Jan 2020 (actual)
- Primary completion
- 28 Jul 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 10 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Other | – | 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.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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (3 listed)
- Unable to meaningfully interact with staff;
- Unable to read and understand English; or
- Has significant cognitive impairment per the nephrologist or Principal Investigator
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | 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 | 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. | Other | Other |
Primary outcome
Evaluation of clinical stabilization through standard clinical dialysis labs
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Week 4
The EQ-5D tool will be used
Evaluation of clinical and psychological stabilization through assessment of patient symptoms.
Time frame: Week 1 and Week 4
The ESAS-r:Renal tool will be used
Satisfaction with the modality options education
Time frame: Week 1 and Week 4
Survey of patient experience
Type of Dialysis Modality chosen by the patient
Time frame: Week 1 and Week 4
Dialysis modality choice as reported by the patient
Actual Type of Dialysis Modality used by the patient
Time frame: 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
Time frame: 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
Time frame: Week 3 and month 3
Survey measuring patient activation (PAM-13) survey
Evaluation of patient satisfaction
Time frame: Week 4 or discharge from the program whichever comes first
Survey of satisfaction with the program
Evaluation of the program process for time utilization
Time frame: 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
Time frame: 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
Time frame: Week 1 through week 4
Number of referrals to the program and subsequent number of admissions to the program.
Evaluation of the program efficiency
Time frame: Week 1 through week 4
Average length of stay for each patient in the program.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wael F Hussein, MBBS principal investigator
Satellite Healthcare, Inc.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ESRD and Hemodialysis, run by Satellite Healthcare at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jug Atwal (650-404-3606, atwalJ@satellitehealth.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of clinical stabilization through standard clinical dialysis labs (time frame: On admission, week 4 and day 90). The study lists 20 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2021.