Evaluation of the Optimal Transition Program

September 21, 2021 updated by: Satellite Healthcare
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • California
      • Oakland, California, United States, 94609
        • Recruiting
        • Satellite Healthcare Oakland
      • Sacramento, California, United States, 95834
        • Recruiting
        • Satellite Healthcare Sacramento
    • Tennessee
      • Memphis, Tennessee, United States, 38111
        • Recruiting
        • Satellite Healthcare Chickasaw Gardens

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Other: 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: 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: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
On admission, week 4 and day 90
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.
At week one and week 4.
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.
At week one and week 4.
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.
At week one, week 4, day 90, day 180 and day 360.
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
At week one and week 4, and changes between week one and week 4.
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
At week one and day 90
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
Day 30, day 90, 6 months and 12 months
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
Day 30, day 90, 6 months and 12 months
Evaluation of clinical and psychological stabilization through a quality of life measurement.
Time Frame: Week 4
The EQ-5D tool will be used
Week 4
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
Week 1 and Week 4
Satisfaction with the modality options education
Time Frame: Week 1 and Week 4
Survey of patient experience
Week 1 and Week 4
Type of Dialysis Modality chosen by the patient
Time Frame: Week 1 and Week 4
Dialysis modality choice as reported by the patient
Week 1 and Week 4
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
week 4, month 3, 6, 12, 18 and 24
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
Week 1, 2, 3, 4
Evaluation of patient activation
Time Frame: Week 3 and month 3
Survey measuring patient activation (PAM-13) survey
Week 3 and month 3
Evaluation of patient satisfaction
Time Frame: Week 4 or discharge from the program whichever comes first
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 Frame: Week 1 through week 4
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 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.
Week 1 through week 4
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.
Week 1 through week 4
Evaluation of the program efficiency
Time Frame: Week 1 through week 4
Average length of stay for each patient in the program.
Week 1 through week 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Satellite Healthcare

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 29, 2020

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 28, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 5, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 6, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 10, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 22, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 21, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SIH124_Optional Transition

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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