Trial Outcomes & Findings for Individualized Patient Decision Making for Treatment Choices Among Minorities With Lupus (NCT NCT02319525)

NCT ID: NCT02319525

Last Updated: 2017-07-18

Results Overview

Patient self-administered, validated measure of decisional conflict, most commonly used as the primary outcome in RCTs of decision aids (change score). The score ranges from 0 (no decisional conflict) to 100 (extreme decisional conflict). Decisional conflict represents a state of uncertainty about a choice or course of action and is more likely in situations involving high-stakes choices with important potential gains and losses, value tradeoffs in selecting a choice or a course of action (vs. the alternative) or uncertain outcomes.

Recruitment status

COMPLETED

Study phase

Target enrollment

301 participants

Primary outcome timeframe

Baseline and after viewing the decision-aid or the standard hand-out (pamphlet) on the same visit as the intervention (preferred) but before treatment decision-making (usually within 1 week)

Results posted on

2017-07-18

Participant Flow

Participant milestones

Participant milestones
Measure	Decision Aid Participants received decision aid tool providing information about medication choices for lupus nephritis	Pamphlet Participants received the standard American College of Rheumatology lupus pamphlet
Overall Study STARTED	153	148
Overall Study Primary Research Completion	151	147
Overall Study COMPLETED	151	147
Overall Study NOT COMPLETED	2	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Decision Aid Participants received decision aid tool providing information about medication choices for lupus nephritis	Pamphlet Participants received the standard American College of Rheumatology lupus pamphlet
Overall Study Withdrawal by Subject	2	1

Baseline Characteristics

Individualized Patient Decision Making for Treatment Choices Among Minorities With Lupus

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Decision Aid n=151 Participants Participants received decision aid tool providing information about medication choices for lupus nephritis	Pamphlet n=147 Participants Participants received the standard American College of Rheumatology lupus pamphlet	Total n=298 Participants Total of all reporting groups
Sex: Female, Male Female	151 Participants n=5 Participants	147 Participants n=7 Participants	298 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Not answered	2 participants n=5 Participants	0 participants n=7 Participants	2 participants n=5 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	148 Participants n=5 Participants	146 Participants n=7 Participants	294 Participants n=5 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Age, Continuous	37.1 Years n=5 Participants	37.6 Years n=7 Participants	37.3 Years n=5 Participants
Race/Ethnicity, Customized Asian	11 participants n=5 Participants	9 participants n=7 Participants	20 participants n=5 Participants
Race/Ethnicity, Customized Hispanic/Latino	41 participants n=5 Participants	37 participants n=7 Participants	78 participants n=5 Participants
Race/Ethnicity, Customized Non-Hispanic Black	70 participants n=5 Participants	71 participants n=7 Participants	141 participants n=5 Participants
Race/Ethnicity, Customized Non-Hispanic White	20 participants n=5 Participants	24 participants n=7 Participants	44 participants n=5 Participants
Race/Ethnicity, Customized Other	7 participants n=5 Participants	6 participants n=7 Participants	13 participants n=5 Participants
Region of Enrollment United States	151 participants n=5 Participants	147 participants n=7 Participants	298 participants n=5 Participants
Decisional conflict	33.37 units on a scale STANDARD_DEVIATION 29.55 • n=5 Participants	37.48 units on a scale STANDARD_DEVIATION 29.85 • n=7 Participants	35.4 units on a scale STANDARD_DEVIATION 29.72 • n=5 Participants
Knowledge about immunosuppressives Adequate Knowledge	90 participants n=5 Participants	89 participants n=7 Participants	179 participants n=5 Participants
Knowledge about immunosuppressives Inadequate Knowledge	61 participants n=5 Participants	58 participants n=7 Participants	119 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and after viewing the decision-aid or the standard hand-out (pamphlet) on the same visit as the intervention (preferred) but before treatment decision-making (usually within 1 week)

Population: All participants who received either the Decision Aid or Pamphlet

Outcome measures

Outcome measures
Measure	Decision Aid n=151 Participants Participants received decision aid tool providing information about medication choices for lupus nephritis	Pamphlet n=147 Participants Participants received the standard American College of Rheumatology lupus pamphlet
Change From Baseline in Decisional Conflict Scale Scores	21.80 units on a scale Standard Deviation 30.89	12.69 units on a scale Standard Deviation 24.41

PRIMARY outcome

Timeframe: After viewing the guide or standard hand-out on the same visit as the intervention (preferred) but before treatment decision-making (usually within 1 week)

Population: All participants who received either the Decision Aid or Pamphlet.

Concordance between values related (for or against starting) immunosuppressive drugs with patients' decision (to start or not start) immunosuppressive drugs, in those with adequate knowledge about benefits/harms of immunosuppressive drugs, assessed using validated instruments for values regarding immunosuppressive drugs, knowledge about immunosuppressive drugs, and treatment decision-making (patient's decision to start immunosuppressive drug).

Outcome measures

Outcome measures
Measure	Decision Aid n=151 Participants Participants received decision aid tool providing information about medication choices for lupus nephritis	Pamphlet n=147 Participants Participants received the standard American College of Rheumatology lupus pamphlet
Informed Choice (Validated Instruments for Values Regarding Immunosuppressives, Knowledge About Immunosuppressives, and Treatment Decision-making) No Informed Choice	89 participants	101 participants
Informed Choice (Validated Instruments for Values Regarding Immunosuppressives, Knowledge About Immunosuppressives, and Treatment Decision-making) Informed Choice Made	62 participants	46 participants

SECONDARY outcome

Timeframe: After viewing the guide or standard hand-out on the same visit as the intervention (preferred) but before treatment decision-making (usually within 1 week)

Population: Only participants having a current lupus nephritis and requiring immunosuppressive medication change/initiation or participants with newly diagnosed lupus nephritis starting an immunosuppressive medication.

This scale assessed how much decision-making control they would like to have versus actually experienced. There are 5 responses for 5 control options: active, active shared, collaborative, passive shared and passive, which were collapsed into active (active, active shared), collaborative, and passive (passive shared and passive), as previously (and pre-specified). Concordance was assessed between desired and actual role played by each patient. We present these data for patients with current flare only, since only they were making a decision about the immunosuppressive drugs; patients with past lupus flare were not included in the denominator.

Outcome measures

Outcome measures
Measure	Decision Aid n=35 Participants Participants received decision aid tool providing information about medication choices for lupus nephritis	Pamphlet n=33 Participants Participants received the standard American College of Rheumatology lupus pamphlet
Control Preferences Scale: Patient Participation in Decision-making No concordance between roles	2 participants	5 participants
Control Preferences Scale: Patient Participation in Decision-making Concordance between roles	33 participants	28 participants

SECONDARY outcome

Timeframe: After viewing the guide or standard hand-out on the same visit as the intervention (preferred) (usually within 1 week)

Population: All participants who received either the Decision Aid or Pamphlet.

This was assessed using the interpersonal processes of care (IPC), an 18-item validated patient-reported measure of patient-physician communication and care processes. The score ranges from 18 (worst) to 90 (best) and the scale is a patient-reported measure of patient-physician communication and care processes.

Outcome measures

Outcome measures
Measure	Decision Aid n=149 Participants Participants received decision aid tool providing information about medication choices for lupus nephritis	Pamphlet n=147 Participants Participants received the standard American College of Rheumatology lupus pamphlet
Patient Physician Communication (Interpersonal Processes of Care (IPC)	83.64 units on a scale Standard Deviation 7.69	83.06 units on a scale Standard Deviation 7.28

SECONDARY outcome

Timeframe: After viewing the guide or standard hand-out on the same visit as the intervention (preferred) (usually within 1 week)

This was done by analyzing the audio-recorded patient-physician discussion in patients with current lupus nephritis flare. The APCC is a validated instrument to measure 'active patient participation.' APCC assesses indicators and facilitators of patient participation. The unit of coding is the utterance, the oral analogue of a sentence. The range is 0 to unlimited. Patient participation is measured by the number of questions, number of concerns expressed, and act of assertiveness (e.g., preferences, introducing topics, making requests). These are 'active' forms of participation because of their influence on clinician behavior and the structure and content of the consultation. The APPC also assess clinician behaviors that facilitate and support patient participation, partnership-building and supportive talk (e.g., reassurance, empathy). We present doctor patient-centered communication. higher scores indicates better patient participation and communication.

Outcome measures

Outcome measures
Measure	Decision Aid n=16 Participants Participants received decision aid tool providing information about medication choices for lupus nephritis	Pamphlet n=17 Participants Participants received the standard American College of Rheumatology lupus pamphlet
Analysis of Audiotaped Physician-patient Interaction (Using the Active Patient Participation Coding Scheme (APPC)): Doctor Patient-centered Communication	5.1 units on a scale Standard Deviation 2.1	3.7 units on a scale Standard Deviation 1.9

SECONDARY outcome

Timeframe: After viewing the guide or standard hand-out on the same visit as the intervention (preferred) (usually within 1 week)

Acceptability of the decision-aid (information quality and quantity, presentation style and usefulness) was assessed using a validated acceptability survey on 4-point scale ranging from "excellent" to "poor" (response options were: excellent, good, fair and poor). The number of patients rating each of the five statements as "excellent" (vs. other ratings) was compared between the two treatment arms.

Outcome measures

Outcome measures
Measure	Decision Aid n=151 Participants Participants received decision aid tool providing information about medication choices for lupus nephritis	Pamphlet n=147 Participants Participants received the standard American College of Rheumatology lupus pamphlet
Acceptability (Number of Participants Rating Each Statement as "Excellent") Impact of lupus nephritis	74 Participants	49 Participants
Acceptability (Number of Participants Rating Each Statement as "Excellent") Risk factors	64 Participants	40 Participants
Acceptability (Number of Participants Rating Each Statement as "Excellent") Medication options	76 Participants	49 Participants
Acceptability (Number of Participants Rating Each Statement as "Excellent") Evidence about medications	71 Participants	35 Participants
Acceptability (Number of Participants Rating Each Statement as "Excellent") Studies about other patients	64 Participants	32 Participants

SECONDARY outcome

Timeframe: After viewing the guide or standard hand-out on the same visit as the intervention (preferred) (usually within 1 week)

Population: One patient from pamphlet group did not respond to this question, therefore valid responses from pamphlet were 146, not 147

Feasibility of the decision-aid vs. pamphlet was assessed using a single statement "The education guide was easy to use". Patients rated this on 5-point ordinal scale ranging from "strongly agree" to "strongly disagree" (response options were: strongly agree, agree, neither agree nor disagree, disagree, strongly disagree). The number of patients was compared between the two treatment arms.

Outcome measures

Outcome measures
Measure	Decision Aid n=151 Participants Participants received decision aid tool providing information about medication choices for lupus nephritis	Pamphlet n=146 Participants Participants received the standard American College of Rheumatology lupus pamphlet
Feasibility (Number of Participants Rating the Feasibility of Using Decision-aid or Pamphlet- Referred to as Education Guide in This Statement) Neither Agree nor Disagree	73 Participants	74 Participants
Feasibility (Number of Participants Rating the Feasibility of Using Decision-aid or Pamphlet- Referred to as Education Guide in This Statement) Strongly Disagree	1 Participants	3 Participants
Feasibility (Number of Participants Rating the Feasibility of Using Decision-aid or Pamphlet- Referred to as Education Guide in This Statement) Disagree	1 Participants	13 Participants
Feasibility (Number of Participants Rating the Feasibility of Using Decision-aid or Pamphlet- Referred to as Education Guide in This Statement) Agree	75 Participants	55 Participants
Feasibility (Number of Participants Rating the Feasibility of Using Decision-aid or Pamphlet- Referred to as Education Guide in This Statement) Strongly Agree	1 Participants	1 Participants
Feasibility (Number of Participants Rating the Feasibility of Using Decision-aid or Pamphlet- Referred to as Education Guide in This Statement) Missing	0 Participants	1 Participants

Adverse Events

Decision Aid

Serious events: 1 serious events

Other events: 0 other events

Deaths: 1 deaths

Pamphlet

Serious events: 1 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Decision Aid n=151 participants at risk Participants received decision aid tool providing information about medication choices for lupus nephritis	Pamphlet n=147 participants at risk Participants received the standard American College of Rheumatology lupus pamphlet
Vascular disorders Right ventricular failure	0.66% 1/151 • Number of events 1 • 3 months	0.00% 0/147 • 3 months
Vascular disorders Subarachnoid hemorrhage	0.00% 0/151 • 3 months	0.68% 1/147 • Number of events 1 • 3 months

Other adverse events

Adverse event data not reported

Additional Information

Dr. Jasvinder Singh, Principal Investigator

UAB

Phone: 2059343235

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place