Using a highly innovative methodology, the Multiphase Optimization Strategy (MOST), the purpose of this study is to pilot test, an optimization trial approach to develop and refine the decision partnering skills of persons with stage 4 chronic kidney disease and their caregivers. Using a 2x2x2 full factorial design, 64 dyads (patients and one identified caregiver) will be randomized to receive one or more lay coach-delivered decision partnering training components, based on Pearlin's Stress-Health Model of Family Caregiving and Rini's Social Support Effectiveness theory. The components include: 1) caregiver coaching on effective decision support (1 vs. 3 sessions); 2) caregiver decision support communication training (1 session vs. none); and 3) patient social support effectiveness psychoeducation (yes vs. no).
Patients
Age ≥18;
EMR documented diagnosis of stage 4 CKD (2 eGFR 29-15 within 90 days);
Ability to speak and read English and complete baseline questionnaires;
Patients
Receiving hospice;
Receiving dialysis;
Medical record documentation of active unmedicated severe mental illness, moderate-severe dementia, suicidal ideation, uncorrected hearing loss, and active substance abuse.
Factorial
ImPart - Improving Chronic Kidney Disease Decisional Partnerships
BehavioralImPart is a decision support intervention developed and refined in partnership with a advisory group of patients with and caregivers of people living with Chronic Kidney Disease. The program is designed to support decision-making throughout the illness experience.
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Treatment groupsSee each treatment group below.
Acceptability of Intervention Measure
four-item measure of implementation outcomes that are often considered "leading indicators" of implementation success; higher score indicate greater acceptability (highest score - 20)
Intervention Appropriateness Measure
Four-item measure of implementation outcomes that are often considered "leading indicators" of implementation success; higher score indicate greater appropriateness (highest score - 20)
Feasibility of Intervention
Intervention completion rate (# participants completing assigned components) will be tabulated, ≥75% completion rates for assigned components will be considered evidence of feasibility
Feasibility of Data Collection
Intervention assessment completion rate (# participants completing each study assessment) will be tabulated, ≥75% completion rates for study assessments will be considered evidence of feasibility
Health-related decision process for patient as measured by the Decision Conflict Scale
16-item measure; perceptions of uncertainty in choosing options, factors contributing to uncertainty (e.g., feeling uninformed, unclear values) and feeling that decisions were informed and values-based - Scores range from 0 \[no decisional conflict\] to 100 \[extremely high decisional conflict\].
Health-related decision process for patient as measured by the Social Support Effectiveness- Questionnaire
25 item measure; perceptions of help received in last 3 months with higher scores indicating more effective support - The total possible score is 66 points
Patient and Caregiver well-being/distress as measured by the Hospital Anxiety and Depression Scale
14 items total, items measure anxiety and depressive symptoms. Higher scores=worse anxiety/depression - Scoring for each item ranges from zero to three, with three denoting highest anxiety or depression level. A total subscale score of \>8 points out of a possible 21 denotes considerable symptoms of anxiety or depression.
Patient wellbeing/quality of life as measured by the Kidney Disease Quality of Life Scale (KDQOL 36)
36 items measure three components: physical health score, mental health score, and kidney disease health score. Physical health score, mental health score, and kidney disease health score are averaged scores of sub-scales. The range of each score and each sub-scale is 0 - 100, and higher values indicate better QOL status
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University of Alabama at Birmingham
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
