search
Back to results

Empowering Patients On Choices for Renal Replacement Therapy (Aim 3) (EPOCH-RRT) (EPOCH-RRT)

Primary Purpose

Chronic Kidney Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Decision Aid
Sponsored by
Arbor Research Collaborative for Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Chronic Kidney Disease focused on measuring Chronic Kidney Disease, Hemodialysis, Peritoneal Dialysis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 18 years and older
  • Speaks English
  • Has access to the internet

Exclusion Criteria:

Sites / Locations

  • Arbor Research Collaborative for Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

No Intervention

Arm Label

Intervention arm

Control arm

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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".
Knowledge
Measured using scale from Cavanaugh K"Patient 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
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.

Secondary Outcome Measures

Full Information

First Posted
June 15, 2015
Last Updated
April 4, 2017
Sponsor
Arbor Research Collaborative for Health
Collaborators
University of Michigan, Henry Ford Health System, National Kidney Foundation, American Association of Kidney Patients, Patient-Centered Outcomes Research Institute
search

1. Study Identification

Unique Protocol Identification Number
NCT02488317
Brief Title
Empowering Patients On Choices for Renal Replacement Therapy (Aim 3) (EPOCH-RRT)
Acronym
EPOCH-RRT
Official Title
Empowering Patients On Choices for Renal Replacement Therapy (Aim 3)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
May 2015 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Arbor Research Collaborative for Health
Collaborators
University of Michigan, Henry Ford Health System, National Kidney Foundation, American Association of Kidney Patients, Patient-Centered Outcomes Research Institute

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease
Keywords
Chronic Kidney Disease, Hemodialysis, Peritoneal Dialysis

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Allocation
Randomized
Enrollment
234 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention arm
Arm Type
Other
Arm Description
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.
Arm Title
Control arm
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Decision Aid
Intervention Description
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.
Primary Outcome Measure Information:
Title
Preference for Shared Decision Making
Description
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
Title
Decisional Conflict
Description
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
Title
Decision Self-efficacy
Description
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
Title
Knowledge
Description
Measured using scale from Cavanaugh K"Patient 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
Title
Preparation for Decision Making
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18 years and older Speaks English Has access to the internet Exclusion Criteria:
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francesca Tentori, MD, MS
Organizational Affiliation
Arbor Research Collaborative for Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Arbor Research Collaborative for Health
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48104
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
30954312
Citation
Subramanian L, Zhao J, Zee J, Knaus M, Fagerlin A, Perry E, Swartz J, McCall M, Bryant N, Tentori F. Use of a Decision Aid for Patients Considering Peritoneal Dialysis and In-Center Hemodialysis: A Randomized Controlled Trial. Am J Kidney Dis. 2019 Sep;74(3):351-360. doi: 10.1053/j.ajkd.2019.01.030. Epub 2019 Apr 4.
Results Reference
derived

Learn more about this trial

Empowering Patients On Choices for Renal Replacement Therapy (Aim 3) (EPOCH-RRT)

We'll reach out to this number within 24 hrs