Table 3.
Goals | Actions | Potential Challengesa | Solutions | Timeframe, yr |
---|---|---|---|---|
Insomnia | ||||
Test CBT and explore integration of exercise with CBT | Conduct clinical trial | CBT adaptation to dialysis setting | Expert, interdisciplinary clinical team | 4–5 |
Provider buy-in | Provider outreach to facilitate implementation and promote sustainability | |||
Exercising in dialysis clinic | Patient outreach, local champions | |||
Exercising at home | ||||
Test effectiveness of site-specific insomnia protocols including online CBT and CBT adapted for dialysis | Perform provider outreach | Health literacy of patients | Simple, accessible protocols that incorporate patient input | 3–5 |
Develop algorithms | Internet access, tablet availability | Patient outreach, local champions | ||
Develop infrastructure for treatment delivery | Patient adherence | Dialysis organization outreach | ||
Test online CBT for hemodialysis | Dialysis personnel and provider buy-in | Tablet manufacturer outreach | ||
Test safety and efficacy of at least one drug for insomnia in patients on dialysis | Select drug | Business risk to pharmaceutical companies | Pharmaceutical industry-independent funding | 2–3 |
Conduct clinical trial | Contraindications to drugs | Industry outreach | ||
Unknown patient preferences | Patient outreach, local champions | |||
Muscle cramps | ||||
Measure frequency, duration and severity of cramps to characterize problem | Investigate measures from other clinical settings | Lack of existing data | Potential KHI proposal | 1 |
Develop and pilot test an assessment tool for cramping | Language, cultural differences | Include non-English-speaking patients and patients from different cultural backgrounds | ||
Test acceptability of available, low-risk interventions (e.g., pickle juice, mustard) | Conduct pilot tests | Unknown patient preferences | Patient outreach, local champions | 3 |
Dialysis personnel buy-in | Dialysis organization outreach | |||
Lack of experience with agent | Industry partnership | |||
Test effectiveness of treatments | Select most promising interventions from pilot testing for pragmatic clinical trial | Lack of existing data | Patient outreach, local champions | 5–7 |
Conduct smaller clinical trials that incorporate physiologic measures | Dialysis personnel buy-in | Dialysis organization outreach | ||
Fatigue | ||||
Develop a standardized checklist for medical workup | Develop checklist | Need for balancing completeness and feasibility | Engage multidisciplinary partners | 1 |
High number of potential conditions for screening | Modify evidence-based algorithms from other disciplines | |||
Cost of work-up | Dialysis organization outreach | |||
Potential for duplicative testing | ||||
Ownership of findings and subsequent management | ||||
Test efficacy of standard of care versus exercise versus exercise plus CBT | Identify exercise approach | Implementation | Align with existing social work and CBT programs at partnered dialysis organizations | 3–4 |
Develop protocol with patient engagement (consider patient preferences and acceptance) | Sustainability | Early involvement of stakeholders to facilitate implementation and promote sustainability | ||
Conduct clinical trial | Facility workflows | Expert, interdisciplinary clinical team | ||
Legal | ||||
Explore psychostimulants and assess associated patient preferences and risk tolerance | Develop protocol for PK/PD modeling study | Lack of existing data | Pharmaceutical industry-independent funding | 1 |
Develop protocol for study assessing patient risk–benefit, tolerance, and preferences | Potential harm | Industry outreach | ||
Contraindications to drugs | Patient preference and risk tolerance assessment | |||
Lack of interest from pharmaceutical companies | ||||
Negative effect on sleep |
CBT, cognitive–behavioral therapy; KHI, Kidney Health Initiative, PK/PD, pharmacokinetic/pharmacodynamic.
Funding and recruitment challenges were common to all three symptoms and are excluded from the table.