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

NCT02488317 | Completed Results

• 1 other identifier: 1109201303123
• Study Type: interventional
• Target: 234
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Kidney Disease

Keywords

Chronic Kidney Disease; Hemodialysis; Peritoneal Dialysis

Outcome Measures

Primary Outcomes (5)

• 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.

  6 months

• 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.

  6 months

• 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".

  6 months

• 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).

  6 months

• 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.

  6 months

Study Arms (2)

Intervention arm

OTHER

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

Control arm

NO INTERVENTION

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.

Interventions

Decision Aid OTHER

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 arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

• Arbor Research Collaborative for Health: lead
• University of Michigan: collaborator
• Henry Ford Health System: collaborator
• National Kidney Foundation, United States: collaborator
• American Association of Kidney Patients: collaborator
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (1)

Arbor Research Collaborative for Health

Ann Arbor, Michigan, 48104, United States

Location

Related Publications (1)

• 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.

  PMID: 30954312 DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Decision Support Techniques

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Investigative Techniques

Results Point of Contact

• Title: Dr. Francesca Tentori
• Organization: Arbor Research Collaborative for Health

francesca.tentori@arborresearch.org

7346654108

Study Officials

• Francesca Tentori, MD, MS

  Arbor Research Collaborative for Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2015
• First Posted: July 2, 2015
• Study Start: May 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: May 10, 2017
• Results First Posted: December 28, 2016

Record last verified: 2017-04

Locations

US (1)