Chronic Kidney DiseaseEPOCH-RRTNCT02488317
Empowering Patients On Choices for Renal Replacement Therapy (Aim 3) (EPOCH-RRT)
A study testing Decision Aid in people with Chronic Kidney Disease, run by Arbor Research Collaborative for Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease
- What is being tested?
- Decision Aid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 234 participants
- Where
- 1 siteUnited States
- Study dates
- May 2015to Dec 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years and older
- Speaks English
- Has access to the internet
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Arbor Research Collaborative for Health
Ann Arbor, Michigan, 48104
About this study
Official title: Empowering Patients On Choices for Renal Replacement Therapy (Aim 3)
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
- Being tested
- Decision Aid
- Keywords
- Chronic Kidney Disease, Hemodialysis, Peritoneal Dialysis
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Decision AidOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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".
Measured: 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).
Measured: 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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2015 (estimated)
- Study startMay 2015
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Enrolment
- 234 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arbor Research Collaborative for Health
- Sponsor type
- University, hospital or other
- Collaborators
- University of Michigan, Henry Ford Health System, National Kidney Foundation, United States, American Association of Kidney Patients, Patient-Centered Outcomes Research Institute
- Responsible party
- Sponsor
- Investigators
- Francesca Tentori, MD, MS, Principal investigator, Arbor Research Collaborative for Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02488317
- Sponsor's protocol ID
- 1109201303123
- Acronym
- EPOCH-RRT
- Status last verified
- Apr 2017
- First submitted
- 15 Jun 2015
- Last updated
- 10 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 30954312
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Empowering Patients On Choices for Renal Replacement Therapy (Aim 3)
- ClinicalTrials.gov ID
- NCT02488317
- Acronym / sponsor ID
- EPOCH-RRT / 1109201303123
- Conditions
- Chronic Kidney Disease
- Keywords
- Chronic Kidney Disease, Hemodialysis, Peritoneal Dialysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 234 participants (actual)
- Lead sponsor
- Arbor Research Collaborative for HealthUniversity, hospital or other
- Collaborators
- University of Michigan, Henry Ford Health System, National Kidney Foundation, United States, American Association of Kidney Patients, Patient-Centered Outcomes Research Institute
- Study start
- May 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 2 Jul 2015 (estimated)
- Results
- Posted 28 Dec 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Other | Other: Decision AidThese 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years and older
- Speaks English
- Has access to the internet
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Decision AidDecision-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 | Intervention arm |
Primary outcome
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.
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.
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".
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).
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30954312Subramanian 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francesca Tentori, MD, MS principal investigator
Arbor Research Collaborative for Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Decision Aid in people with Chronic Kidney Disease, run by Arbor Research Collaborative for Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Dec 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preference for Shared Decision Making (time frame: 6 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02488317, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2017.