The Effect of Structured Education and Decision Support on Patient Outcomes for Patients Starting Dialysis Treatment in Emergency Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 86
- Locations
- 1
- Primary Endpoint
- Clinical and biochemical outcomes
Study Overview
Brief Summary
Aim: This study aimed to develop a decision supported education program and evaluate the effect on the following dialysis patient outcomes: treatment satisfaction, treatment adherence, self-care, quality of life, depression, patient laboratory results, and clinical results.
Design: This study used a randomized controlled design. Method: Dialysis Education and Decision Tree Support application developed. Patients who started renal replacement treatment in urgent condition were placed into a Dialysis Education Program group (n=43) and Decision Tree Supported Education Program group (n=43) using the simple random sampling method. Training was provided to both groups using curriculum and training tools during two interviews. The decision tree application was used during an additional third interview with the patients in the "Decision Tree Supported Education Program" group. Data collected using the "Demographical and Clinical Data" form, the "Patient Assessment of Chronic Illness Care-Patient" Scale, the "Self-Care Ability of Chronic Dialysis Patients Assessment Scale," the "General Quality of Life Scale," and the "Patient Health Survey."
Detailed Description
Hypotheses of the study H1) A structured DTSEP improves clinical and biochemical outcomes in dialysis patients.
H2) A structured DTSEP improves treatment adherence in dialysis patients. H3) A structured DTSEP improves satisfaction in dialysis patients. H4) A structured DTSEP improves disease management in dialysis patients. H5) A structured DTSEP increases self-care competence in dialysis patients. H6) A structured DTSEP has a positive effect on patients' quality of life. H7) A structured DTSEP reduces the incidence of depression in dialysis patients.
METHOD Design and setting This experimental study used a randomized controlled design.
Participants and data collection The universe of this study consisted of patients started dialysis treatment under emergency conditions in public and private hospitals within the last one year. After predicting an effect size of 0.80 (alpha 0.05), 86 patients were included in the study. Patients were divided into a "Dialysis Education Program" (DEP) only group (n=43) and a "Decision Tree-Support Education Program" (DTSEP) group (n=43) using simple sequential sampling method. A homogenity test was performed to ensure that the patients in both groups were similar.
Inclusion criteria: Inclusion criteria required that patients: were >18 years of age, had been diagnosed with an emergent indication for dialysis treatment, displayed ESRD symptoms or signs and a glomerular filtration rate (GFR) of 5-10 mL/min/1.73 m2) (Nesrallah et al., 2014), had completed at least three hemodialysis sessions, had no problems with communication, and consented to participate in the study. Illiterate patients and those who had previously undergone RRT were excluded from the study.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •diagnosed with an emergent indication for dialysis treatment, displayed ESRD symptoms or signs and a glomerular filtration rate (GFR) of 5-10 mL/min/1.73 m2) completed at least three hemodialysis sessions, had no problems with communication, and consented to participate in the study.
Exclusion Criteria
- •Illiterate patients and Those who had previously undergone RRT were excluded from the study
Arms & Interventions
Dialysis Education Program (DEP)
Patients beginning urgent renal replacement treatment were placed into a Dialysis Education Program group (n=43) All patients in the DEP group were trained on the subjects included in the Dialysis Education Programme with two consequtive interview.
Interview 1: In this 30-minute session, the aim of the training program was explained with an overview of CKD, sparing time for potential patient questions. The second training day was scheduled according to patients' agenda and their next hemodialysis session.
Interview 2: RRT options were explained in the 30-minute training session, followed by interactive discussion with patients, ensuring that patients understood the information. When the training was completed, a guidebook ("Treatment Options in Kidney Failure-Conscious Start") was distributed to participants
Intervention: Dialysis Education for Urgent Dialysis Start Patient (Behavioral)
Decision Tree Supported Education Program group (n=43)
Patients beginning urgent renal replacement treatment were placed into a Decision Tree Supported Education Program group (n=43) All patients were trained on the subjects included in the Dialysis Education Programme with three consequtive interview.
Interview 1: In this 30-minute session, the aim of the training program was explained with an overview of CKD, sparing time for potential patient questions. The second training day was scheduled according to patients' agenda and their next hemodialysis session.
Interview 2: RRT options were explained in the 30-minute training session, followed by interactive discussion with patients, ensuring that patients understood the information. When the training was completed, a guidebook ("Treatment Options in Kidney Failure-Conscious Start") was distributed to participants Interview 3: Developed DecisionTree application ("My Life, My Choice") was performed . RRT options were assessed interactively during further discussions (30 minutes)
Intervention: Decision Aid Supported Education (Behavioral)
Outcomes
Primary Outcomes
Clinical and biochemical outcomes
Time Frame: Before intervention and one month after intervention
Clinical and biochemical outcomes include measurements of hemoglobin, hematocrit, albumin, total protein, C-reactive protein (CRP), calcium, phosphorus, parathormone, blood urea nitrogen (BUN), creatinine, blood pressure, residual urine volume, and Kt/V
Treatment adherence
Time Frame: Before intervention and one month after intervention
Treatment adherence was measured using the End Stage Renal Disease Adherence Questionnaire (ESRD-AQ), which consisted of four subgroups (adherence to total dialysis sessions, medications, fluid restrictions, and dietary recommendations), with higher scores indicating increased adherence
Patient Assessment of Chronic Illness Care Scale-Patient Form
Time Frame: Before intervention and one month after intervention
Patient Assessment of Chronic Illness Care Scale-Patient Form (Turkish PACIC): Consists of five sub-dimensions: patient participation, decision-making, goal setting/guidance, problem solving, and monitoring/coordination. Higher scale score indicates that individuals with chronic disease are satisfied with the care they receive and that chronic disease management is adequate
Self-Care Ability
Time Frame: Before intervention and one month after intervention
It is a data collection tool that used to asses ability of participant about medication, diet, hygenic care and mental state. Higher scores indicate better self-care ability of patiens
Quality of Life Measurement
Time Frame: Before intervention and one month after intervention
The EQ-5D is a general health scale used to measure quality of life. The scale consists of two parts. Part A., the EQ-5D index scale, consists of five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Part B. the EQ-5D VAS scale, is a visual analog scale in which individuals give values between 0 and 100
Psychological assessment
Time Frame: Before intervention and one month after intervention
Aims to make a psychological assessment of patients in the last two weeks of dialysis, measuring the extent to which such problems disturb patients
Secondary Outcomes
No secondary outcomes reported
Investigators
Zehra Aydin
AssistantProfessor
Atlas University
