Clinical trial NCT04263233: Evaluation of the Optimal Transition Program
Official title: Evaluation of the Optimal Transition Program
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: ESRD
Hemodialysis
Keywords: ESRD
Hemodialysis
Education
Evaluation
Lead sponsor: Satellite Healthcare
Sponsor class: OTHER
First posted: 2020-02-10
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
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.

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Evaluation of clinical stabilization through standard clinical dialysis labs
timeFrame: On admission, week 4 and day 90
measure: Evaluation of clinical stabilization through standard clinical dialysis blood pressure measurements
timeFrame: At week one and week 4.
measure: Evaluation of clinical stabilization through standard clinical dialysis measurements of Intradialytic blood pressures
timeFrame: At week one and week 4.
measure: Evaluation of clinical stabilization through standard clinical dialysis measurements of ultrafiltration
timeFrame: At week one, week 4, day 90, day 180 and day 360.
measure: Evaluation of clinical stabilization through standard clinical dialysis measurements of weight
timeFrame: At week one and week 4, and changes between week one and week 4.
measure: Evaluation of clinical stabilization through standard clinical dialysis measurements
timeFrame: At week one and day 90
measure: Evaluation of clinical stabilization through standard clinical dialysis collection of patient hospitalizations.
timeFrame: Day 30, day 90, 6 months and 12 months
measure: Evaluation of clinical stabilization through standard clinical dialysis records.
timeFrame: Day 30, day 90, 6 months and 12 months
measure: Evaluation of clinical and psychological stabilization through a quality of life measurement.
timeFrame: Week 4
measure: Evaluation of clinical and psychological stabilization through assessment of patient symptoms.
timeFrame: Week 1 and Week 4
measure: Satisfaction with the modality options education
timeFrame: Week 1 and Week 4
measure: Type of Dialysis Modality chosen by the patient
timeFrame: Week 1 and Week 4
measure: Actual Type of Dialysis Modality used by the patient
timeFrame: week 4, month 3, 6, 12, 18 and 24
measure: Evaluation of patient knowledge of dialysis and modalities
timeFrame: Week 1, 2, 3, 4
measure: Evaluation of patient activation
timeFrame: Week 3 and month 3
measure: Evaluation of patient satisfaction
timeFrame: Week 4 or discharge from the program whichever comes first
measure: Evaluation of the program process for time utilization
timeFrame: Week 1 through week 4
measure: Evaluation of the program process for cost utilization
timeFrame: Week 1 through week 4
measure: Evaluation of the feasibility of the program
timeFrame: Week 1 through week 4
measure: Evaluation of the program efficiency
timeFrame: Week 1 through week 4
Secondary outcomes:
Other outcomes:
Locations:
city: Oakland
country: United States
facility: Satellite Healthcare Oakland
state: California
city: Sacramento
country: United States
facility: Satellite Healthcare Sacramento
state: California
city: Memphis
country: United States
facility: Satellite Healthcare Chickasaw Gardens
state: Tennessee
Study officials:
affiliation: Satellite Healthcare, Inc.
name: Wael F Hussein, MBBS
role: PRINCIPAL_INVESTIGATOR
References: