Background
Methods/design
Study design summary
Phase I: Development of informational and financial assistance interventions
Description of informational intervention
Description of the financial assistance intervention
Phase 2: Randomized controlled trial assessing the individual and combined effectiveness of informational and financial interventions
Target population and eligibility criteria
Recruitment of participants
Reimbursement and enrollment of potential kidney donors
Randomization
Usual care group
Intervention groups
Data collection, follow-Up and outcomes
Measures assessed through interventions
PATIENT | ||||
---|---|---|---|---|
Measure | Baseline | 1 | 3 | 6 |
Month | Month | Month | ||
Current Treatment Information
| ||||
Date and Place of Initiation of Dialysis | X | |||
Presence of AV* Fistula or AV Graft | X | |||
Presence of Peritoneal Catheter | X | X | X | X |
Exposure to Information about Kidney Disease Treatment
| ||||
In Center Hemodialysis Information | X | X | X | X |
Home Hemodialysis Information | X | X | X | X |
Peritoneal Dialysis Information | X | X | X | X |
Kidney Transplant Information | X | X | X | X |
Live Donor Kidney Transplant Information | X | X | X | X |
Discussions with Health Care Providers about Kidney Disease Treatment
| ||||
Occurrence of Physician Discussions-Nephrologists | X | |||
Satisfaction with Patient-Physician Discussions | X | |||
Physician Recommendations Regarding LRT* | X | |||
Belief & Knowledge about Treatment for Kidney Failure, Interest in LRT
| ||||
Beliefs About Treatment for Kidney Failure | X | X | X | X |
Knowledge of LRT | X | X | X | X |
Interest in LRT | X | X | X | X |
Consideration of LRT (stage placement) | X | X | X | X |
Elements of Shared Decision Making
| ||||
Stage in Decision Making [43] | X | X | X | X |
Decision Self-Efficacy [43] | X | X | X | X |
Decisional Conflict Scale [44] | X | X | X | X |
Interest in Switching Renal Replacement Therapy | ||||
Pursuit of LRT, Barriers to Completing Behavior Stages
| ||||
Quality of Family Discussion | X | X | X | X |
Information on Donor | X | X | X | X |
Barriers to Patient-Family Discussion | X | X | X | X |
Barriers to Patient-Physician Discussion | X | X | X | X |
Barriers to Starting Evaluation | X | X | X | X |
Barriers to Completing Evaluation | X | X | X | X |
Mediators and Correlates of Pursuit of LRT
| ||||
X | ||||
In-Center Dialysis Care - Nephrologist Communication, Receipt of Information | X | X | X | X |
Family Functioning [46] | X | |||
Depressed Mood PRIME-MD/PHQ*[48] | X | X | X | |
Social Function - Emotional Support, Instrumental Support, Informational Support, Social Isolation [47] | X | |||
Personal Financial Well-being Scale [49] | X | |||
Charlson Comorbidity Index [55] | X | |||
Sociodemographic Information | X | |||
Assessment of Book and Video
| ||||
Assessment of Book and Video | X | X | X | |
Health Literacy and Numeracy
| ||||
Rapid Estimate of Adult Literacy in Medicine (REALM) [50] | X | |||
X |