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Decision Aid for Therapeutic Options In Sickle Cell Disease

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ClinicalTrials.gov Identifier: NCT02326597
Recruitment Status : Completed
First Posted : December 29, 2014
Results First Posted : October 9, 2018
Last Update Posted : October 9, 2018
Sponsor:
Collaborator:
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
Lakshmanan Krishnamurti, Emory University

Tracking Information
First Submitted Date  ICMJE December 18, 2014
First Posted Date  ICMJE December 29, 2014
Results First Submitted Date  ICMJE August 4, 2017
Results First Posted Date  ICMJE October 9, 2018
Last Update Posted Date October 9, 2018
Actual Study Start Date  ICMJE January 2015
Actual Primary Completion Date April 17, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 19, 2017)
Acceptability of Decision Aid Education Assessed by the Acceptability Survey [ Time Frame: Post Visit 1 (Up to 2 Weeks) ]
Subjects will take an acceptability of education questionnaire which is a 8-item survey to assess the comprehension of education received for the decision aid tool. Each item will be scored on a scale from 1-4 where 1=poor, 2=fair, 3=good, and 4=excellent. Scores will be rated individually 1-4 according to each item. There is no overall total score.
Original Primary Outcome Measures  ICMJE
 (submitted: December 22, 2014)
Acceptability of education change from Baseline Visit to Visit 2 to Visit 3 to Visit 4 [ Time Frame: Baseline (V1), 3-4 mths (V2) and 6-8 mths (V3) 8-11 mths (V4) for crossover group ]
Subjects will take an acceptability of education questionnaire which is a 10-item survey to assess the comprehension of education received.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 19, 2017)
  • Mean Decisional Self-Efficacy Scale Score [ Time Frame: Month 3, Month 6 ]
    The Decision Self-Efficacy Scale measures self-confidence or belief in one's ability to make decisions, including participate in shared decision making. Items are scored on a scale of 0-4 where 0 is not at all confident and 4 represents very confident.Total scores range from 0 (not at all confident) to 100 (very confident). A score of 0 means 'extremely low self- efficacy' and a score of 100 means 'extremely high self-efficacy.
  • Mean Difference in Decisional Conflict Scale Scores [ Time Frame: Baseline, Month 3 ]
    Decisional Conflict scale responses are scored for the total score, uncertainty sub-score, informed sub-score, values clarity sub-score, support sub-score and effective decision sub-score. The total score ranges from 0 (no decisional conflict) to 100 (extremely high decisional conflict). The uncertainty sub-score ranges from 0 (feels extremely certain about best choice) to 100 (feels extremely uncertain about best choice). The informed sub-score ranges from 0 (feels extremely informed) to 100 (feels extremely uninformed). The values clarity sub-score ranges from 0 (feels extremely clear about personal values for benefits & risks) to 100 (feels extremely unclear about personal values). The support sub-score ranges from 0 (feels extremely supported in decision making) to 100 (feels extremely unsupported in decision making). The effective decision sub-score ranges from 0 (good decision) to 100 (bad decision).
  • Mean Difference in Decisional Conflict Scale Scores [ Time Frame: Baseline, Month 6 ]
    Decisional Conflict scale responses are scored for the total score, uncertainty sub-score, informed sub-score, values clarity sub-score, support sub-score and effective decision sub-score. The total score ranges from 0 (no decisional conflict) to 100 (extremely high decisional conflict). The uncertainty sub-score ranges from 0 (feels extremely certain about best choice) to 100 (feels extremely uncertain about best choice). The informed sub-score ranges from 0 (feels extremely informed) to 100 (feels extremely uninformed). The values clarity sub-score ranges from 0 (feels extremely clear about personal values for benefits & risks) to 100 (feels extremely unclear about personal values). The support sub-score ranges from 0 (feels extremely supported in decision making) to 100 (feels extremely unsupported in decision making). The effective decision sub-score ranges from 0 (good decision) to 100 (bad decision).
  • Mean Values Survey Score [ Time Frame: Post Visit 1 (Up to 2 Weeks) ]
    The values survey consists of 14 multiple choice questions to measure what is important to a patient when making decisions. The patient decision aid will be tested in the twelve domains of the international patient decision aid standards collaboration criteria checklist. Respondents will be asked to identify perceived importance of individual items (such as procedure related complications, decreasing complication risks, experiencing less pain) and to rate this importance on a 10 point likert scale (0-10) where 1 indicates "not important to me at all" and 10 indicates "extremely important to me". Scores are then converted it to an 11 point scale and averaged.
  • Mean Change in Preparation for Decision Making Scale Score [ Time Frame: Month 3, Month 6 ]
    Preparation for Decision Making Scale assesses a patient's perception of how useful a decision aid or other decision support intervention is in preparing the respondent to communicate with their practitioner at a consultation focused on making a health decision. The preparation for decision-making scale is scored on a 0-100 scale. Higher scores indicate a higher perceived level of preparation for decision making. The total score on the decision making scale is a continuous outcome.
  • Mean Knowledge Survey Scores [ Time Frame: Baseline, Month 3, Month 6 ]
    Knowledge Survey is a 25 multiple choice questionnaire which assesses how much knowledge is being retained after information about risks is received. The knowledge survey is scored as percent correct answers at each time point. This is a set of questions to test knowledge and understanding about sickle cell disease and treatments. As such the answers are dichotomous i.e true or false. The total score of percent correct answers is scored in the range of 0-100%.
  • Mean Decisional Regret Scale Score [ Time Frame: Visit 3 ]
    Decision Regret Scale measures distress or remorse after a health care decision. The subject rates regret using a 5 point Likert scale in answering the following questions; 1. It was the right decision 2. I regret the decision 3. I would go for the same decision if I were to do it again 4. The decision caused me a lot of harm 5. It was a wise decision. Total scores range from 0 to 100. A score of 0 means no regret; a score of 100 means high regret.
Original Secondary Outcome Measures  ICMJE
 (submitted: December 22, 2014)
  • Decision Self-Efficacy Scale change from Baseline Visit to Visit 2 to Visit 3 to Visit 4 [ Time Frame: Baseline (V1), 3-4 mths (V2) and 6-8 mths (V3) 8-11 mths (V4) for crossover group ]
    Decision Self-Efficacy Scale measures self-confidence or belief in one's ability to make decisions, including participate in shared decision making.
  • Decisional Conflict Scale change from Baseline Visit to Visit 2 to Visit 3 to Visit 4 [ Time Frame: Baseline (V1), 3-4 mths (V2) and 6-8 mths (V3) 8-11 mths (V4) for crossover group ]
    Decisional Conflict Scale measures personal perceptions of uncertainty in choosing options, modifiable factors contributing to uncertainty such as feeling uninformed, unclear about personal values and unsupported in decision making and effective decision making such as feeling the choice is informed, values-based, likely to be implemented and expressing satisfaction with the choice.
  • Values survey change from Baseline Visit to Visit 2 to Visit 3 to Visit 4 [ Time Frame: Baseline (V1), 3-4 mths (V2) and 6-8 mths (V3) 8-11 mths (V4) for crossover group ]
    Values survey consists of 14 multiple choice and 6 fill in the blank questions to measure what is important to a patient when making decisions.
  • Realistic Expectations change from Baseline Visit to Visit 2 to Visit 3 to Visit 4 [ Time Frame: Baseline (V1), 3-4 mths (V2) and 6-8 mths (V3) 8-11 mths (V4) for crossover group ]
    Realistic Expectations is a 2-item survey assessing risk.
  • Preparation for Decision Making Scale change from Baseline Visit to Visit 2 to Visit 3 to Visit 4 [ Time Frame: Baseline (V1), 3-4 mths (V2) and 6-8 mths (V3) 8-11 mths (V4) for crossover group ]
    Preparation for Decision Making Scale assesses a patient's perception of how useful a decision aid or other decision support intervention is in preparing the respondent to communicate with their practitioner at a consultation focused on making a health decision.
  • Knowledge Survey change from Baseline Visit to Visit 2 to Visit 3 to Visit 4 [ Time Frame: Baseline (V1), 3-4 mths (V2) and 6-8 mths (V3) 8-11 mths (V4) for crossover group ]
    Knowledge Survey is a 25 multiple choice questionnaire which assesses how much knowledge is being retained after information about risks is received.
  • Choice Predisposition and Decision change from Baseline Visit to Visit 2 to Visit 3 to Visit 4 [ Time Frame: Baseline (V1), 3-4 mths (V2) and 6-8 mths (V3) 8-11 mths (V4) for crossover group ]
    Choice Predisposition and Decision a multiple choice and fill in the blank assessment of a person's leaning towards or propensity to select an option and stated choice among alternatives.
  • Stage of Decision Making change from Baseline Visit to Visit 2 to Visit 3 to Visit 4 [ Time Frame: Baseline (V1), 3-4 mths (V2) and 6-8 mths (V3) 8-11 mths (V4) for crossover group ]
    Stage of Decision Making is a questionnaire consisting of 10 multiple choice question to measure your consideration of different choices.
  • Decision Regret Scale change from Baseline Visit to Visit 2 to Visit 3 to Visit 4 [ Time Frame: Baseline (V1), 3-4 mths (V2) and 6-8 mths (V3) 8-11 mths (V4) for crossover group ]
    Decision Regret Scale measures distress or remorse after a health care decision.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Decision Aid for Therapeutic Options In Sickle Cell Disease
Official Title  ICMJE Comparative Effectiveness of a Decision Aid for Therapeutic Options in Sickle Cell Disease
Brief Summary

Sickle cell disease (SCD) is an inherited disorder with chronic multi-system manifestations affecting 100,000 individuals in the US, largely of minority origin and associated with substantial morbidity, premature mortality, individual suffering, healthcare costs and loss of productivity. Disease modifying treatments such as hydroxyurea, chronic blood transfusion and curative bone marrow transplantation are offered to patients based on physician preference and current practice informed by clinical trials. Decision aids are tools that could help translate evidence from these sources into practice by helping clinicians involve patients in making deliberate choices based on accessible information about the options available and their outcomes and to help them make decisions based on their values and preferences.

The overarching goal of this project is to implement a web based decision aid individualized to patient characteristics to help patients with SCD achieve more accurate perception of risks and benefits of treatment options and make decisions in congruence with their values and preferences. Investigators will use a randomized controlled trial of the effectiveness of a web-based decision aid to give patients accurate information about risks and benefits of therapies that enable patients to make decisions based on their individual values and preferences.

Detailed Description

Sickle cell disease (SCD) is an inherited disorder with chronic multi-system manifestations affecting 100,000 individuals in the US, largely of minority origin and associated with substantial morbidity, premature mortality, individual suffering, healthcare costs and loss of productivity. Disease modifying treatments such as hydroxyurea, chronic blood transfusion and curative bone marrow transplantation are offered to patients based on physician preference and current practice informed by clinical trials. Decision aids are tools that could help translate evidence from these sources into practice by helping clinicians involve patients in making deliberate choices based on accessible information about the options available and their outcomes and to help them make decisions based on their values and preferences.

There are minimal data about patient-related barriers to and attitudes towards, the use of curative therapies in SCD. Thus significant gaps remain in the understanding of patient perspectives, in the provision of accurate information about risks and benefits of therapies and of incorporating patients' values and preferences in offering treatment options. There is a need for research that helps to understand patient values and preferences and determines how to help patients make informed treatment decision in congruence with their values and preferences.

The overarching goal of this project is to implement a web based decision aid individualized to patient characteristics to help patients with SCD achieve more accurate perception of risks and benefits of treatment options and make decisions in congruence with their values and preferences. Investigators will use a randomized controlled trial of the effectiveness of a web-based decision aid to give patients accurate information about risks and benefits of therapies that enable patients to make decisions based on their individual values and preferences.

Investigators hypothesize that a web based decision aid individualized to patient characteristics can improve knowledge and help patients with SCD achieve more accurate perception of risks and benefits of treatment options and is associated with lower decisional conflict than standard care.

The aims of the study are to estimate the effectiveness of the decision aid tailored to individual patient characteristics on patient knowledge, patient involvement in decision-making and decision-making quality, when compared with usual care.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Condition  ICMJE
  • Sickle Cell Disease
  • Sickle Cell Anemia
  • Hemoglobin SS
  • Hemoglobin SC
  • Hemoglobin Beta Thalassemia
Intervention  ICMJE
  • Other: Decision Aid Tool
    The tool is a web based decision aid that provides information about the risks and benefits associated with sickle cell disease therapies. Participants will be provided a unique access ID and password to access the information.
  • Other: Standard Practice
    Standard of care teaching and discussion regarding treatment options given by patient's healthcare provider.
Study Arms  ICMJE
  • Active Comparator: Standard Practice
    Participants will receive education regarding treatment consideration from their healthcare provider/team as per standard practice (usual care).
    Intervention: Other: Standard Practice
  • Experimental: Standard Practice + Decision Aid
    Participants will receive standard of care teaching and discussion in addition to web-based decision aid tool access.
    Interventions:
    • Other: Decision Aid Tool
    • Other: Standard Practice
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 19, 2017)
134
Original Estimated Enrollment  ICMJE
 (submitted: December 22, 2014)
120
Actual Study Completion Date  ICMJE April 17, 2017
Actual Primary Completion Date April 17, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Individuals with sickle cell disease ages 8 to 80 years, inclusive OR
  • Parent/legal guardian of patients (age < 18 years) with sickle cell disease who are directly involved in decision making regarding sickle cell disease healthcare treatment OR
  • Health care provider directly involved in care of individuals with sickle cell disease, including child of parent/legal guardian enrolled in study
  • Patients/parents/caregivers who have made a past decision to not obtain treatment of the considered option or who have not obtained treatment of the chosen option in past 12 months.
  • All participants will be able to comprehend English
  • Patients/Parent/Legal guardian will have access to the internet from iPad, smart phone or personal computer

Exclusion Criteria:

  • Family Members/Individuals/Caregivers not directly involved in decision-making regarding sickle cell disease healthcare.
  • Patient/parent/legal guardian who has already made a decision to begin and has started the treatment option.
  • Child < 18 years of parent/legal guardian who is participating in Cohort A of this study and randomized to the control arm and not the decision aid arm.
  • Spouse, significant other, or other family member involved in decision making for child <18 years if parent/legal guardian of child already enrolled into this study.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 8 Years to 80 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02326597
Other Study ID Numbers  ICMJE IRB00076096a
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Lakshmanan Krishnamurti, Emory University
Study Sponsor  ICMJE Emory University
Collaborators  ICMJE Patient-Centered Outcomes Research Institute
Investigators  ICMJE
Principal Investigator: Lakshmanan Krishnamurti, MD Emory University
PRS Account Emory University
Verification Date December 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP