Evaluation of the Optimal Transition Program

NCT ID: NCT04263233

Last Updated: 2021-09-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-29

Study Completion Date

2022-12-31

Brief Summary

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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

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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.

Conditions

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ESRD Hemodialysis

Study Design

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Observational Model Type

OTHER

Study Time Perspective

OTHER

Study Groups

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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.

Analysis using descriptive statistics of patient clinical outcomes.

Intervention Type 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.

Intervention Type 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.

Intervention Type OTHER

Data will be collected using tracking tools throughout the program.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Satellite Healthcare

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Wael F Hussein, MBBS

Role: PRINCIPAL_INVESTIGATOR

Satellite Healthcare, Inc.

Locations

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Satellite Healthcare Oakland

Oakland, California, United States

Site Status RECRUITING

Satellite Healthcare Sacramento

Sacramento, California, United States

Site Status RECRUITING

Satellite Healthcare Chickasaw Gardens

Memphis, Tennessee, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Jug Atwal

Role: CONTACT

650-404-3606

Legg Veronica, M.S.

Role: CONTACT

650-404-3736

Other Identifiers

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SIH124_Optional Transition

Identifier Type: -

Identifier Source: org_study_id

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