Evaluation of the Optimal Transition Program

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: Recruiting
• Conditions: Hemodialysis; ESRD
• Intervention / Treatment: 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.

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: Observational
• Enrollment (Anticipated): 20

Contacts and Locations

• Study Contact: Name: Jug Atwal; Phone Number: 650-404-3606; Email: atwalJ@satellitehealth.com
• Study Contact Backup: Name: Legg Veronica, M.S.; Phone Number: 650-404-3736; Email: leggv@satellitehealth.com

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

Eligibility Criteria

• 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

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Satellite Healthcare

Study record dates

Study Major Dates

• Study Start (Actual): January 29, 2020
• Primary Completion (Anticipated): July 28, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: February 5, 2020
• First Submitted That Met QC Criteria: February 6, 2020
• First Posted (Actual): February 10, 2020

Study Record Updates

• Last Update Posted (Actual): September 22, 2021
• Last Update Submitted That Met QC Criteria: September 21, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Evaluation; ESRD; Education; Hemodialysis
• Other Study ID 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