Evaluation of the Optimal Transition Program

Hemodialysis Clinical Trial

Official title:

Evaluation of the Optimal Transition Program

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04263233
• Other study ID #: SIH124_Optional Transition
• Status: Recruiting
• Start date: January 29, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: September 2021
• Source: Satellite Healthcare
• Contact: Jug Atwal
• Phone: 650-404-3606
• Email: atwalJ[@]satellitehealth.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 31, 2022
• Est. primary completion date: July 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• ESRD
• Hemodialysis

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	Satellite Healthcare Chickasaw Gardens	Memphis	Tennessee
United States	Satellite Healthcare Oakland	Oakland	California
United States	Satellite Healthcare Sacramento	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
Satellite Healthcare

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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
Primary	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
Primary	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
Primary	Evaluation of clinical and psychological stabilization through a quality of life measurement.	The EQ-5D tool will be used	Week 4
Primary	Evaluation of clinical and psychological stabilization through assessment of patient symptoms.	The ESAS-r:Renal tool will be used	Week 1 and Week 4
Primary	Satisfaction with the modality options education	Survey of patient experience	Week 1 and Week 4
Primary	Type of Dialysis Modality chosen by the patient	Dialysis modality choice as reported by the patient	Week 1 and Week 4
Primary	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
Primary	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
Primary	Evaluation of patient activation	Survey measuring patient activation (PAM-13) survey	Week 3 and month 3
Primary	Evaluation of patient satisfaction	Survey of satisfaction with the program	Week 4 or discharge from the program whichever comes first
Primary	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
Primary	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
Primary	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
Primary	Evaluation of the program efficiency	Average length of stay for each patient in the program.	Week 1 through week 4