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

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ClinicalTrials.gov Identifier: NCT02488317
Recruitment Status : Completed
First Posted : July 2, 2015
Results First Posted : December 28, 2016
Last Update Posted : May 10, 2017
Sponsor:
Collaborators:
University of Michigan
Henry Ford Health System
National Kidney Foundation
American Association of Kidney Patients
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
Arbor Research Collaborative for Health

Study Description
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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.


Condition or disease Intervention/treatment Phase
Chronic Kidney Disease Other: Decision Aid Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 234 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Other
Official Title: Empowering Patients On Choices for Renal Replacement Therapy (Aim 3)
Study Start Date : May 2015
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.
 Other: 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.
No Intervention: 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.


Outcome Measures
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Primary Outcome Measures :
  1. Preference for Shared Decision Making [ Time Frame: 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.

  2. Decisional Conflict [ Time Frame: 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.

  3. Decision Self-efficacy [ Time Frame: 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".

  4. Knowledge [ Time Frame: 6 months ]
    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).

  5. Preparation for Decision Making [ Time Frame: 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.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02488317


Locations
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United States, Michigan
Arbor Research Collaborative for Health
Ann Arbor, Michigan, United States, 48104
Sponsors and Collaborators
Arbor Research Collaborative for Health
University of Michigan
Henry Ford Health System
National Kidney Foundation
American Association of Kidney Patients
Patient-Centered Outcomes Research Institute
Investigators
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Principal Investigator: Francesca Tentori, MD, MS Arbor Research Collaborative for Health
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Arbor Research Collaborative for Health
ClinicalTrials.gov Identifier: NCT02488317    
Other Study ID Numbers: 1109201303123
First Posted: July 2, 2015    Key Record Dates
Results First Posted: December 28, 2016
Last Update Posted: May 10, 2017
Last Verified: April 2017
Keywords provided by Arbor Research Collaborative for Health:
Chronic Kidney Disease
Hemodialysis
Peritoneal Dialysis
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
 Male Urogenital Diseases
Renal Insufficiency
Chronic Disease
Disease Attributes
Pathologic Processes