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
|Condition or disease||Intervention/treatment||Phase|
|Systemic Lupus Erythematosus||Other: Computerized patient decision-aid Other: Usual care (lupus pamphlet)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||301 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Individualized Patient Decision Making for Treatment Choices Among Minorities With Lupus|
|Actual Study Start Date :||January 2014|
|Actual Primary Completion Date :||November 2016|
|Actual Study Completion Date :||December 2016|
Experimental: Computerized patient decision-aid
A computerized decision-aid showing benefits and harms of medications in words patients prefer
Other: Computerized patient decision-aid
The decision-aid contained information regarding lupus and lupus nephritis, its impact on patient lives and benefits and harms of lupus nephritis treatments, focused on immunosuppressive medications compared to each other. The content of the decision-aid allowed individualization based on patient preference for details on certain aspects, as well as the desire to view additional, optional sections of the decision-aid.
Active Comparator: Usual care (lupus pamphlet)
A handout/pamphlet from a non-profit organization on lupus and lupus medications (American College of Rheumatology [ACR])
Other: Usual care (lupus pamphlet)
Patient received the standard handout/pamphlet from a non-profit organization (American College of Rheumatology [ACR]) regarding lupus and its treatments, that explained risks and benefits of various treatments
- Change From Baseline in Decisional Conflict Scale Scores [ 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) ]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.
- Informed Choice (Validated Instruments for Values Regarding Immunosuppressives, Knowledge About Immunosuppressives, and Treatment Decision-making) [ 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) ]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).
- Control Preferences Scale: Patient Participation in Decision-making [ 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) ]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.
- Patient Physician Communication (Interpersonal Processes of Care (IPC) [ Time Frame: After viewing the guide or standard hand-out on the same visit as the intervention (preferred) (usually within 1 week) ]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.
- Analysis of Audiotaped Physician-patient Interaction (Using the Active Patient Participation Coding Scheme (APPC)): Doctor Patient-centered Communication [ Time Frame: 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.
- Acceptability (Number of Participants Rating Each Statement as "Excellent") [ Time Frame: 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.
- Feasibility (Number of Participants Rating the Feasibility of Using Decision-aid or Pamphlet- Referred to as Education Guide in This Statement) [ Time Frame: After viewing the guide or standard hand-out on the same visit as the intervention (preferred) (usually within 1 week) ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02319525
|United States, Alabama|
|University of Alabama at Birmingham|
|Birmingham, Alabama, United States, 35294|
|Principal Investigator:||Jasvinder Singh, MBBS, MPH||University of Alabama at Birmingham|