Individualized Patient Decision Making for Treatment Choices Among Minorities With Lupus

NCT02319525 | Completed Results

• 1 other identifier: CE-1304-6631
• Study Type: interventional
• Target: 301
• Locations: 1 country
• Sites: 1

Brief Summary

The study will compare the efficacy of the usual education materials to individualized computerized decision guide on decision conflict of patients with lupus nephritis making treatment decisions regarding immunosuppressive therapies.

Conditions

Systemic Lupus Erythematosus

Keywords

lupus nephritis; lupus; decision-making; minorities; immunosuppressive medications; decision-aid; treatment; Decision conflict; SLE

Outcome Measures

Primary Outcomes (2)

• Change From Baseline in Decisional Conflict Scale Scores

  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.

  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)

• Informed Choice (Validated Instruments for Values Regarding Immunosuppressives, Knowledge About Immunosuppressives, and Treatment Decision-making)

  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).

  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)

Secondary Outcomes (5)

• Control Preferences Scale: Patient Participation in Decision-making

  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)

• Patient Physician Communication (Interpersonal Processes of Care (IPC)

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

• Analysis of Audiotaped Physician-patient Interaction (Using the Active Patient Participation Coding Scheme (APPC)): Doctor Patient-centered Communication

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

• Acceptability (Number of Participants Rating Each Statement as "Excellent")

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

• Feasibility (Number of Participants Rating the Feasibility of Using Decision-aid or Pamphlet- Referred to as Education Guide in This Statement)

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

Study Arms (2)

Computerized patient decision-aid

EXPERIMENTAL

A computerized decision-aid showing benefits and harms of medications in words patients prefer

Other: Computerized patient decision-aid

Usual care (lupus pamphlet)

ACTIVE COMPARATOR

A handout/pamphlet from a non-profit organization on lupus and lupus medications (American College of Rheumatology \[ACR\])

Other: Usual care (lupus pamphlet)

Interventions

Computerized patient decision-aid OTHER

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.

Computerized patient decision-aid

Usual care (lupus pamphlet) OTHER

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

Usual care (lupus pamphlet)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adult female lupus nephritis patients, currently having a flare of lupus nephritis and considering change or initiation of an immunosuppressive medication (current flare) or had had flare of lupus nephritis in the past and at risk for a future lupus nephritis flare (future flare)

You may not qualify if:

• male; lupus but no lupus nephritis; change in lupus immunosuppressive treatment already made for current flare; end stage renal disease on dialysis; renal transplant or candidate for a renal transplant

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Related Publications (2)

• Singh JA, Fraenkel L, Green C, Alarcon GS, Barton JL, Saag KG, Hanrahan LM, Raymond SC, Kimberly RP, Leong AL, Reyes E, Street RL Jr, Suarez-Almazor ME, Eakin GS, Marrow L, Morgan CJ, Caro B, Sloan JA, Jandali B, Garcia SR, Grossman J, Winthrop KL, Trupin L, Dall'Era M, Meara A, Rizvi T, Chatham WW, Yazdany J. Individualized decision aid for diverse women with lupus nephritis (IDEA-WON): A randomized controlled trial. PLoS Med. 2019 May 8;16(5):e1002800. doi: 10.1371/journal.pmed.1002800. eCollection 2019 May.

  PMID: 31067237 DERIVED

• Singh JA, Shah N, Green C. Individualized patient decision-aid for immunosuppressive drugs in women with lupus nephritis: study protocol of a randomized, controlled trial. BMC Musculoskelet Disord. 2017 Jan 31;18(1):53. doi: 10.1186/s12891-017-1408-5.

  PMID: 28143529 DERIVED

MeSH Terms

Conditions

Lupus Erythematosus, Systemic; Lupus Nephritis

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Limitations and Caveats

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

Results Point of Contact

• Title: Dr. Jasvinder Singh, Principal Investigator
• Organization: UAB

jasvinder.md@gmail.com

2059343235

Study Officials

• Jasvinder Singh, MBBS, MPH

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 5, 2014
• First Posted: December 18, 2014
• Study Start: January 1, 2014
• Primary Completion: November 1, 2016
• Study Completion: December 1, 2016
• Last Updated: July 18, 2017
• Results First Posted: January 31, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)