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Trial record 10 of 906 for:    Lupus

Individualized Patient Decision Making for Treatment Choices Among Minorities With Lupus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02319525
Recruitment Status : Completed
First Posted : December 18, 2014
Results First Posted : January 31, 2017
Last Update Posted : July 18, 2017
Sponsor:
Collaborator:
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
Jasvinder Singh, MD, MPH, University of Alabama at Birmingham

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Supportive Care
Condition Systemic Lupus Erythematosus
Interventions Other: Computerized patient decision-aid
Other: Usual care (lupus pamphlet)
Enrollment 301
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Decision Aid Pamphlet
Hide Arm/Group Description Participants received decision aid tool providing information about medication choices for lupus nephritis Participants received the standard American College of Rheumatology lupus pamphlet
Period Title: Overall Study
Started 153 148
Primary Research Completion 151 147
Completed 151 147
Not Completed 2 1
Reason Not Completed
Withdrawal by Subject             2             1
Arm/Group Title Decision Aid Pamphlet Total
Hide Arm/Group Description Participants received decision aid tool providing information about medication choices for lupus nephritis Participants received the standard American College of Rheumatology lupus pamphlet Total of all reporting groups
Overall Number of Baseline Participants 151 147 298
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 151 participants 147 participants 298 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
148
  98.0%
146
  99.3%
294
  98.7%
>=65 years
3
   2.0%
1
   0.7%
4
   1.3%
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 151 participants 147 participants 298 participants
37.1
(19 to 69)
37.6
(19 to 66)
37.3
(19 to 69)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 151 participants 147 participants 298 participants
Female
151
 100.0%
147
 100.0%
298
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 151 participants 147 participants 298 participants
Not answered 2 0 2
Asian 11 9 20
Hispanic/Latino 41 37 78
Non-Hispanic Black 70 71 141
Non-Hispanic White 20 24 44
Other 7 6 13
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 151 participants 147 participants 298 participants
151 147 298
Decisional conflict   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 151 participants 147 participants 298 participants
33.37  (29.55) 37.48  (29.85) 35.4  (29.72)
[1]
Measure Description: The Decisional Conflict Scale is a patient self-administered, validated measure of decisional conflict, a state of uncertainty about a course of action. Scores range from 0 (no decisional conflict) to 100 (extremely high decisional conflict).
Knowledge about immunosuppressives   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 151 participants 147 participants 298 participants
Adequate Knowledge 90 89 179
Inadequate Knowledge 61 58 119
[1]
Measure Description: Patients were asked 20 true/false questions regarding lupus nephritis and immunosuppressive drugs. Patients answering at least 75% of questions correctly were considered to have "adequate" knowledge about immunosuppressives. Those answering fewer than 75% of questions correctly were considered to have "inadequate" knowledge.
1.Primary Outcome
Title Change From Baseline in Decisional Conflict Scale Scores
Hide Description 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.
Time Frame 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)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received either the Decision Aid or Pamphlet
Arm/Group Title Decision Aid Pamphlet
Hide Arm/Group Description:
Participants received decision aid tool providing information about medication choices for lupus nephritis
Participants received the standard American College of Rheumatology lupus pamphlet
Overall Number of Participants Analyzed 151 147
Mean (Standard Deviation)
Unit of Measure: units on a scale
21.80  (30.89) 12.69  (24.41)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Decision Aid, Pamphlet
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.005
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
2.Primary Outcome
Title Informed Choice (Validated Instruments for Values Regarding Immunosuppressives, Knowledge About Immunosuppressives, and Treatment Decision-making)
Hide Description 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).
Time Frame 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)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received either the Decision Aid or Pamphlet.
Arm/Group Title Decision Aid Pamphlet
Hide Arm/Group Description:
Participants received decision aid tool providing information about medication choices for lupus nephritis
Participants received the standard American College of Rheumatology lupus pamphlet
Overall Number of Participants Analyzed 151 147
Measure Type: Number
Unit of Measure: participants
Informed Choice Made 62 46
No Informed Choice 89 101
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Decision Aid, Pamphlet
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.08
Comments We compared informed choice vs. no informed choice made between the decision aid and the pamphlet groups.
Method Chi-squared
Comments [Not Specified]
3.Secondary Outcome
Title Control Preferences Scale: Patient Participation in Decision-making
Hide Description 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.
Time Frame 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)
Hide Outcome Measure Data
Hide Analysis Population Description
Only participants having a current lupus nephritis and requiring immunosuppressive medication change/initiation or participants with newly diagnosed lupus nephritis starting an immunosuppressive medication.
Arm/Group Title Decision Aid Pamphlet
Hide Arm/Group Description:
Participants received decision aid tool providing information about medication choices for lupus nephritis
Participants received the standard American College of Rheumatology lupus pamphlet
Overall Number of Participants Analyzed 35 33
Measure Type: Number
Unit of Measure: participants
Concordance between roles 33 28
No concordance between roles 2 5
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Decision Aid, Pamphlet
Comments We compared concordance between preferred and actual roles vs. no concordance between roles between decision aid and pamphlet.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.252
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
4.Secondary Outcome
Title Patient Physician Communication (Interpersonal Processes of Care (IPC)
Hide Description 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.
Time Frame After viewing the guide or standard hand-out on the same visit as the intervention (preferred) (usually within 1 week)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received either the Decision Aid or Pamphlet.
Arm/Group Title Decision Aid Pamphlet
Hide Arm/Group Description:
Participants received decision aid tool providing information about medication choices for lupus nephritis
Participants received the standard American College of Rheumatology lupus pamphlet
Overall Number of Participants Analyzed 149 147
Mean (Standard Deviation)
Unit of Measure: units on a scale
83.64  (7.69) 83.06  (7.28)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Decision Aid, Pamphlet
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.504
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
5.Secondary Outcome
Title Analysis of Audiotaped Physician-patient Interaction (Using the Active Patient Participation Coding Scheme (APPC)): Doctor Patient-centered Communication
Hide Description 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.
Time Frame After viewing the guide or standard hand-out on the same visit as the intervention (preferred) (usually within 1 week)
Hide Outcome Measure Data
Hide Analysis Population Description
Only participants having a current lupus nephritis and requiring immunosuppressive medication change/initiation or participants with newly diagnosed lupus nephritis starting an immunosuppressive medication, who also agreed for an audio-recorded conversation.
Arm/Group Title Decision Aid Pamphlet
Hide Arm/Group Description:
Participants received decision aid tool providing information about medication choices for lupus nephritis
Participants received the standard American College of Rheumatology lupus pamphlet
Overall Number of Participants Analyzed 16 17
Mean (Standard Deviation)
Unit of Measure: units on a scale
5.1  (2.1) 3.7  (1.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Decision Aid, Pamphlet
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.06
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
6.Secondary Outcome
Title Acceptability (Number of Participants Rating Each Statement as "Excellent")
Hide Description 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.
Time Frame After viewing the guide or standard hand-out on the same visit as the intervention (preferred) (usually within 1 week)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Decision Aid Pamphlet
Hide Arm/Group Description:
Participants received decision aid tool providing information about medication choices for lupus nephritis
Participants received the standard American College of Rheumatology lupus pamphlet
Overall Number of Participants Analyzed 151 147
Measure Type: Count of Participants
Unit of Measure: Participants
Impact of lupus nephritis
74
  49.0%
49
  33.3%
Risk factors
64
  42.4%
40
  27.2%
Medication options
76
  50.3%
49
  33.3%
Evidence about medications
71
  47.0%
35
  23.8%
Studies about other patients
64
  42.4%
32
  21.8%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Decision Aid, Pamphlet
Comments statistical analysis comparing the decision-aid vs. pamphlet for patient rating of acceptability of information and presentation related to the "Impact of lupus nephritis"
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.006
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Decision Aid, Pamphlet
Comments statistical analysis comparing the decision-aid vs. pamphlet for patient rating of acceptability of information and presentation related to the "Risk factors"
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.006
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Decision Aid, Pamphlet
Comments statistical analysis comparing the decision-aid vs. pamphlet for patient rating of acceptability of information and presentation related to the "medication options"
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.003
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Decision Aid, Pamphlet
Comments statistical analysis comparing the decision-aid vs. pamphlet for patient rating of acceptability of information and presentation related to the "evidence about medications"
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Decision Aid, Pamphlet
Comments statistical analysis comparing the decision-aid vs. pamphlet for patient rating of acceptability of information and presentation related to the "study about other patients"
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
7.Secondary Outcome
Title Feasibility (Number of Participants Rating the Feasibility of Using Decision-aid or Pamphlet- Referred to as Education Guide in This Statement)
Hide Description 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.
Time Frame After viewing the guide or standard hand-out on the same visit as the intervention (preferred) (usually within 1 week)
Hide Outcome Measure Data
Hide Analysis Population Description
One patient from pamphlet group did not respond to this question, therefore valid responses from pamphlet were 146, not 147
Arm/Group Title Decision Aid Pamphlet
Hide Arm/Group Description:
Participants received decision aid tool providing information about medication choices for lupus nephritis
Participants received the standard American College of Rheumatology lupus pamphlet
Overall Number of Participants Analyzed 151 146
Measure Type: Count of Participants
Unit of Measure: Participants
Strongly Disagree
1
   0.7%
3
   2.1%
Disagree
1
   0.7%
13
   8.9%
Neither Agree nor Disagree
73
  48.3%
74
  50.7%
Agree
75
  49.7%
55
  37.7%
Strongly Agree
1
   0.7%
1
   0.7%
Missing
0
   0.0%
1
   0.7%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Decision Aid, Pamphlet
Comments The test of significance compared all the rows, i.e., all response options for the statement.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.006
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Time Frame 3 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Decision Aid Pamphlet
Hide Arm/Group Description Participants received decision aid tool providing information about medication choices for lupus nephritis Participants received the standard American College of Rheumatology lupus pamphlet
All-Cause Mortality
Decision Aid Pamphlet
Affected / at Risk (%) Affected / at Risk (%)
Total   1/151 (0.66%)      1/147 (0.68%)    
Show Serious Adverse Events Hide Serious Adverse Events
Decision Aid Pamphlet
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/151 (0.66%)      1/147 (0.68%)    
Vascular disorders     
Right ventricular failure * [1]  1/151 (0.66%)  1 0/147 (0.00%)  0
Subarachnoid hemorrhage * [2]  0/151 (0.00%)  0 1/147 (0.68%)  1
*
Indicates events were collected by non-systematic assessment
[1]
1. Decision-aid: Patient with mitral regurgitation died due of right ventricular failure after cardiovascular surgery (Day 53).
[2]
1. Pamphlet: Subarachnoid hemorrhage from posterior circulation aneurysm. Patient died due to central herniation (Day 22)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Decision Aid Pamphlet
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/151 (0.00%)      0/147 (0.00%)    
  1. Study findings may not be generalizable to men with lupus, since we studied only women
  2. It remains to be seen whether our decision-aid can be used by lupus patients with non-renal manifestations
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Jasvinder Singh, Principal Investigator
Organization: UAB
Phone: 2059343235
EMail: jasvinder.md@gmail.com
Layout table for additonal information
Responsible Party: Jasvinder Singh, MD, MPH, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT02319525     History of Changes
Other Study ID Numbers: CE-1304-6631
First Submitted: November 5, 2014
First Posted: December 18, 2014
Results First Submitted: December 29, 2016
Results First Posted: January 31, 2017
Last Update Posted: July 18, 2017