Trial Outcomes & Findings for Empowering Patients On Choices for Renal Replacement Therapy (Aim 3) (EPOCH-RRT) (NCT NCT02488317)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

234 participants

Primary outcome timeframe

6 months

Results posted on

2017-05-10

Participant Flow

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	117	117
Overall Study COMPLETED	63	70
Overall Study NOT COMPLETED	54	47

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intervention Arm n=70 Participants 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.	Control Arm n=70 Participants 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.	Total n=140 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Age, Categorical Between 18 and 65 years	43 Participants n=99 Participants	45 Participants n=107 Participants	88 Participants n=206 Participants
Age, Categorical >=65 years	27 Participants n=99 Participants	25 Participants n=107 Participants	52 Participants n=206 Participants
Age, Continuous	59.16 years STANDARD_DEVIATION 14.59 • n=99 Participants	59.44 years STANDARD_DEVIATION 14.16 • n=107 Participants	59.30 years STANDARD_DEVIATION 14.31 • n=206 Participants
Sex: Female, Male Female	40 Participants n=99 Participants	35 Participants n=107 Participants	75 Participants n=206 Participants
Sex: Female, Male Male	30 Participants n=99 Participants	35 Participants n=107 Participants	65 Participants n=206 Participants
Region of Enrollment United States	70 participants n=99 Participants	70 participants n=107 Participants	140 participants n=206 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Intervention Pre-test n=70 Participants Intervention arm responses prior to accessing the decision aid (N=70)	Intervention Post-test n=63 Participants Intervention arm responses after accessing the decision aid (N=63)	Control n=70 Participants Control arm with no decision aid.
Preference for Shared Decision Making I will decide with little input from Dr.	2 participants	5 participants	0 participants
Preference for Shared Decision Making My doctor(s) and I will decide together	22 participants	19 participants	35 participants
Preference for Shared Decision Making I will decide after considering Dr's opinion	44 participants	38 participants	35 participants
Preference for Shared Decision Making My doctor will decide with little input from me	1 participants	0 participants	0 participants
Preference for Shared Decision Making My doctor will decide but will consider my opinion	1 participants	1 participants	0 participants

PRIMARY outcome

Timeframe: 6 months

Population: All participants who completed the questionnaire were included in these analyses.

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.

Outcome measures

Outcome measures
Measure	Intervention Pre-test n=63 Participants Intervention arm responses prior to accessing the decision aid (N=70)	Intervention Post-test n=70 Participants Intervention arm responses after accessing the decision aid (N=63)	Control Control arm with no decision aid.
Decisional Conflict Intervention pre-test	43.6 scores on a scale Standard Deviation 15.9	42.5 scores on a scale Standard Deviation 17.1	—
Decisional Conflict Intervention post-test	29.1 scores on a scale Standard Deviation 13.7	42.5 scores on a scale Standard Deviation 17.1	—

PRIMARY outcome

Timeframe: 6 months

Population: All participants who completed the questionnaire were included in these analyses.

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".

Outcome measures

Outcome measures
Measure	Intervention Pre-test n=63 Participants Intervention arm responses prior to accessing the decision aid (N=70)	Intervention Post-test n=70 Participants Intervention arm responses after accessing the decision aid (N=63)	Control Control arm with no decision aid.
Decision Self-efficacy Intervention post-test	82.0 scores on a scale Standard Deviation 18.4	79.9 scores on a scale Standard Deviation 17.6	—
Decision Self-efficacy Intervention pre-test	82.8 scores on a scale Standard Deviation 18.0	79.9 scores on a scale Standard Deviation 17.6	—

PRIMARY outcome

Timeframe: 6 months

Population: All participants who completed the questionnaire were included in these analyses.

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).

Outcome measures

Outcome measures
Measure	Intervention Pre-test n=63 Participants Intervention arm responses prior to accessing the decision aid (N=70)	Intervention Post-test n=70 Participants Intervention arm responses after accessing the decision aid (N=63)	Control Control arm with no decision aid.
Knowledge	90.3 scores on a scale Standard Deviation 11.9	76.5 scores on a scale Standard Deviation 15.3	—

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Intervention Pre-test n=63 Participants Intervention arm responses prior to accessing the decision aid (N=70)	Intervention Post-test Intervention arm responses after accessing the decision aid (N=63)	Control Control arm with no decision aid.
Preparation for Decision Making	76.39 units on a scale Standard Deviation 18.86	—	—

Adverse Events

Intervention Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Francesca Tentori

Arbor Research Collaborative for Health

Phone: 7346654108

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place