Evaluation of the Optimal Transition Program
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 3
- 主要终点
- Evaluation of clinical and psychological stabilization through a quality of life measurement.
研究概览
简要总结
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.
详细描述
In this program evaluation the investigators will be reporting on the following program outcomes:
- Clinical and psychosocial stabilization: to include lab values, clinical dialysis parameters, patient-reported symptoms, quality of life, hospitalization and mortality rates.
- Dialysis modality choice with satisfaction with the modality education and continued modality use over 24 months.
- Patient knowledge, activation, and satisfaction.
- Program parameters such as time, costs, referral rate, admissions and length of stay within the program.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •Unable to meaningfully interact with staff;
- •Unable to read and understand English; or
- •Has significant cognitive impairment per the nephrologist or Principal Investigator
结局指标
主要结局
Evaluation of clinical and psychological stabilization through a quality of life measurement.
时间窗: Week 4
The EQ-5D tool will be used
Evaluation of clinical stabilization through standard clinical dialysis labs
时间窗: On admission, week 4 and day 90
Evaluation of changes in the Standard of care monthly dialysis labs
Evaluation of clinical stabilization through standard clinical dialysis blood pressure measurements
时间窗: 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.
Evaluation of clinical stabilization through standard clinical dialysis measurements of Intradialytic blood pressures
时间窗: 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.
Evaluation of clinical stabilization through standard clinical dialysis measurements of ultrafiltration
时间窗: 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.
Evaluation of clinical stabilization through standard clinical dialysis measurements of weight
时间窗: 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
Evaluation of clinical stabilization through standard clinical dialysis measurements
时间窗: At week one and day 90
Dialysis access type as reported in the dialysis treatment sheets
Evaluation of clinical stabilization through standard clinical dialysis collection of patient hospitalizations.
时间窗: Day 30, day 90, 6 months and 12 months
Hospitalization rates as reported in the standard dialysis record for all patients
Evaluation of clinical stabilization through standard clinical dialysis records.
时间窗: Day 30, day 90, 6 months and 12 months
Mortality rates as reported in the standard dialysis record for all patients
Evaluation of clinical and psychological stabilization through assessment of patient symptoms.
时间窗: Week 1 and Week 4
The ESAS-r:Renal tool will be used
Satisfaction with the modality options education
时间窗: Week 1 and Week 4
Survey of patient experience
Type of Dialysis Modality chosen by the patient
时间窗: Week 1 and Week 4
Dialysis modality choice as reported by the patient
Actual Type of Dialysis Modality used by the patient
时间窗: week 4, month 3, 6, 12, 18 and 24
Dialysis modality as reported on the standard dialysis treatment sheets
Evaluation of patient knowledge of dialysis and modalities
时间窗: 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
Evaluation of patient activation
时间窗: Week 3 and month 3
Survey measuring patient activation (PAM-13) survey
Evaluation of patient satisfaction
时间窗: Week 4 or discharge from the program whichever comes first
Survey of satisfaction with the program
Evaluation of the program process for time utilization
时间窗: Week 1 through week 4
Time per patient for visits from program start to completion for each patient
Evaluation of the program process for cost utilization
时间窗: 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.
Evaluation of the feasibility of the program
时间窗: Week 1 through week 4
Number of referrals to the program and subsequent number of admissions to the program.
Evaluation of the program efficiency
时间窗: Week 1 through week 4
Average length of stay for each patient in the program.
次要结局
未报告次要终点