Chronic Kidney Disease
Conditions
Keywords
Chronic Kidney Disease, Hemodialysis, Peritoneal Dialysis
Brief summary
Empowering Patients On Choices for Renal Replacement Therapy (EPOCH-RRT) study seeks to identify factors that matter the most to patients with kidney disease and study how they are impacted by different types of dialysis. The inclusion of patients, caregivers, and patient advocacy organizations as research partners will assure that the study addresses questions of greatest relevance to patients facing the need for dialysis. For Aim 3, the investigators are going to compare measures related to the decision-making process between patients receiving and not receiving a decision aid focusing on Peritoneal Dialysis and Hemodialysis.
Interventions
OTHERDecision Aid
Decision-making outcomes (e.g., self-efficacy) will be compared between patients who received and did not receive a decision aid. These arms were chosen because the current standard of care is for health care providers to discuss options with patients without using a decision aid.
Sponsors
University of Michigan
Henry Ford Health System
National Kidney Foundation, United States
American Association of Kidney Patients
Patient-Centered Outcomes Research Institute
Arbor Research Collaborative for Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years and older * Speaks English * Has access to the internet
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Preference for Shared Decision Making | 6 months | Measured using the scale from Degner, L. F., Sloan, J. A., & Venkatesh, P. (1996). The Control Preferences Scale. The Canadian journal of nursing research= Revue canadienne de recherche en sciences infirmieres, 29(3), 21-43. The CPS is a clinically relevant, easily administered, valid, and reliable measure of preferred roles in health-care decision-making. A pick-one approach was used to identify patient preference for an active, passive or collaborative role in dialysis treatment decision making. |
| Decisional Conflict | 6 months | Measured using the scale from O'Connor, Annette M. Validation of a Decisional Conflict Scale. Medical Decision Making 15, no. 1 (February 1, 1995): 25-30. 16 item scale, responses to each statement are scored from 1 (strongly agree) to 5 (strongly disagree), with negative statements having reverse scoring; thus high scores indicate higher decisional conflict. Mean score per participant is calculated across all items, subtract by 1 and multiplied by 25. Score range= 0-100. Mean scores across all participants in each arm are reported. |
| Decision Self-efficacy | 6 months | Measured through the scale found in Decision Self-Efficacy Ottawa: Ottawa Hospital Research Institute; © 1995 Available from: http://decisionaid.ohri.ca/docs/develop/User\_Manuals/UM\_Decision\_SelfEfficacy.pdf O'Connor 1995 Items are scored 0(not at all confident) to 4 (very confident). Scores are summed across 10 items, divided by 10 and multiplied by 25. Scores range from 0-100. A score of 0 means extremely low self efficacy and a score of 100 means extremely high self efficacy. |
| Knowledge | 6 months | Measured using scale from Cavanaugh KPatient Dialysis Knowledge Is Associated with Permanent Arteriovenous Access Use in Chronic Hemodialysis. Clinical Journal of the American Society of Nephrology 4, no. 5: 950-56) Multiple choice questions with one correct answer per questions. Number of correct questions reported as a percentage of total number of questions (23). |
| Preparation for Decision Making | 6 months | Measured using Bennett, Carol, Validation of a Preparation for Decision Making Scale. Patient Education and Counseling 78, no. 1: 130-33 10 item scale, each item scored from 1 (not at all) to 5 (a great deal). items are summed and scored, converted to a 0-100 scale by subtracting 1 from the summed score and multiplying by 25. Higher scores indicate higher perceived level of preparation for decision making. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intervention Arm These patients will receive the decision aid tool. Decision-making outcomes (e.g., self-efficacy) will be compared between patients who received and did not receive a decision aid. These arms were chosen because the current standard of care is for health care providers to discuss options with patients without using a decision aid.
Decision Aid: Decision-making outcomes (e.g., self-efficacy) will be compared between patients who received and did not receive a decision aid. These arms were chosen because the current standard of care is for health care providers to discuss options with patients without using a decision aid. | 70 |
| Control Arm These patients will not receive the decision aid tool and will be asked to test their knowledge without it. Decision-making outcomes (e.g., self-efficacy) will be compared between patients who received and did not receive a decision aid. These arms were chosen because the current standard of care is for health care providers to discuss options with patients without using a decision aid.
Decision Aid: Decision-making outcomes (e.g., self-efficacy) will be compared between patients who received and did not receive a decision aid. These arms were chosen because the current standard of care is for health care providers to discuss options with patients without using a decision aid. | 70 |
| Total | 140 |
Baseline characteristics
| Characteristic | Control Arm | Intervention Arm | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 25 Participants | 27 Participants | 52 Participants |
| Age, Categorical Between 18 and 65 years | 45 Participants | 43 Participants | 88 Participants |
| Age, Continuous | 59.44 years STANDARD_DEVIATION 14.16 | 59.16 years STANDARD_DEVIATION 14.59 | 59.30 years STANDARD_DEVIATION 14.31 |
| Region of Enrollment United States | 70 participants | 70 participants | 140 participants |
| Sex: Female, Male Female | 35 Participants | 40 Participants | 75 Participants |
| Sex: Female, Male Male | 35 Participants | 30 Participants | 65 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 117 | 0 / 117 |
| serious Total, serious adverse events | 0 / 117 | 0 / 117 |
Outcome results
Primary
Decisional Conflict
Measured using the scale from O'Connor, Annette M. Validation of a Decisional Conflict Scale. Medical Decision Making 15, no. 1 (February 1, 1995): 25-30. 16 item scale, responses to each statement are scored from 1 (strongly agree) to 5 (strongly disagree), with negative statements having reverse scoring; thus high scores indicate higher decisional conflict. Mean score per participant is calculated across all items, subtract by 1 and multiplied by 25. Score range= 0-100. Mean scores across all participants in each arm are reported.
Time frame: 6 months
Population: All participants who completed the questionnaire were included in these analyses.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Pre-test | Decisional Conflict | Intervention pre-test | 43.6 scores on a scale | Standard Deviation 15.9 |
| Intervention Pre-test | Decisional Conflict | Intervention post-test | 29.1 scores on a scale | Standard Deviation 13.7 |
| Intervention Post-test | Decisional Conflict | Intervention pre-test | 42.5 scores on a scale | Standard Deviation 17.1 |
| Intervention Post-test | Decisional Conflict | Intervention post-test | 42.5 scores on a scale | Standard Deviation 17.1 |
Primary
Decision Self-efficacy
Measured through the scale found in Decision Self-Efficacy Ottawa: Ottawa Hospital Research Institute; © 1995 Available from: http://decisionaid.ohri.ca/docs/develop/User\_Manuals/UM\_Decision\_SelfEfficacy.pdf O'Connor 1995 Items are scored 0(not at all confident) to 4 (very confident). Scores are summed across 10 items, divided by 10 and multiplied by 25. Scores range from 0-100. A score of 0 means extremely low self efficacy and a score of 100 means extremely high self efficacy.
Time frame: 6 months
Population: All participants who completed the questionnaire were included in these analyses.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Pre-test | Decision Self-efficacy | Intervention pre-test | 82.8 scores on a scale | Standard Deviation 18 |
| Intervention Pre-test | Decision Self-efficacy | Intervention post-test | 82.0 scores on a scale | Standard Deviation 18.4 |
| Intervention Post-test | Decision Self-efficacy | Intervention pre-test | 79.9 scores on a scale | Standard Deviation 17.6 |
| Intervention Post-test | Decision Self-efficacy | Intervention post-test | 79.9 scores on a scale | Standard Deviation 17.6 |
Primary
Knowledge
Measured using scale from Cavanaugh KPatient Dialysis Knowledge Is Associated with Permanent Arteriovenous Access Use in Chronic Hemodialysis. Clinical Journal of the American Society of Nephrology 4, no. 5: 950-56) Multiple choice questions with one correct answer per questions. Number of correct questions reported as a percentage of total number of questions (23).
Time frame: 6 months
Population: All participants who completed the questionnaire were included in these analyses.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Pre-test | Knowledge | 90.3 scores on a scale | Standard Deviation 11.9 |
| Intervention Post-test | Knowledge | 76.5 scores on a scale | Standard Deviation 15.3 |
Primary
Preference for Shared Decision Making
Measured using the scale from Degner, L. F., Sloan, J. A., & Venkatesh, P. (1996). The Control Preferences Scale. The Canadian journal of nursing research= Revue canadienne de recherche en sciences infirmieres, 29(3), 21-43. The CPS is a clinically relevant, easily administered, valid, and reliable measure of preferred roles in health-care decision-making. A pick-one approach was used to identify patient preference for an active, passive or collaborative role in dialysis treatment decision making.
Time frame: 6 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Intervention Pre-test | Preference for Shared Decision Making | My doctor will decide but will consider my opinion | 1 participants |
| Intervention Pre-test | Preference for Shared Decision Making | My doctor will decide with little input from me | 1 participants |
| Intervention Pre-test | Preference for Shared Decision Making | My doctor(s) and I will decide together | 22 participants |
| Intervention Pre-test | Preference for Shared Decision Making | I will decide after considering Dr's opinion | 44 participants |
| Intervention Pre-test | Preference for Shared Decision Making | I will decide with little input from Dr. | 2 participants |
| Intervention Post-test | Preference for Shared Decision Making | My doctor will decide with little input from me | 0 participants |
| Intervention Post-test | Preference for Shared Decision Making | My doctor(s) and I will decide together | 19 participants |
| Intervention Post-test | Preference for Shared Decision Making | I will decide after considering Dr's opinion | 38 participants |
| Intervention Post-test | Preference for Shared Decision Making | My doctor will decide but will consider my opinion | 1 participants |
| Intervention Post-test | Preference for Shared Decision Making | I will decide with little input from Dr. | 5 participants |
| Control | Preference for Shared Decision Making | I will decide with little input from Dr. | 0 participants |
| Control | Preference for Shared Decision Making | My doctor will decide but will consider my opinion | 0 participants |
| Control | Preference for Shared Decision Making | My doctor(s) and I will decide together | 35 participants |
| Control | Preference for Shared Decision Making | My doctor will decide with little input from me | 0 participants |
| Control | Preference for Shared Decision Making | I will decide after considering Dr's opinion | 35 participants |
Primary
Preparation for Decision Making
Measured using Bennett, Carol, Validation of a Preparation for Decision Making Scale. Patient Education and Counseling 78, no. 1: 130-33 10 item scale, each item scored from 1 (not at all) to 5 (a great deal). items are summed and scored, converted to a 0-100 scale by subtracting 1 from the summed score and multiplying by 25. Higher scores indicate higher perceived level of preparation for decision making.
Time frame: 6 months
Population: This was a comparison of the intervention group before and after using the decision aid to assess its impact on preparing the participant for decision making. The question was therefore not administered to the control group since a similar pre/post comparison could not be tested in this group that was not exposed to the intervention.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Pre-test | Preparation for Decision Making | 76.39 units on a scale | Standard Deviation 18.86 |