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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Health Services Research
Conditions Sickle Cell Disease
Sickle Cell Anemia
Hemoglobin SS
Hemoglobin SC
Hemoglobin Beta Thalassemia
Interventions Other: Decision Aid Tool
Other: Standard Practice
Enrollment 134
Recruitment Details Participants were recruited between January 2015 and May 2016.
Pre-assignment Details Of the 134 participants who signed consent, 120 began study participation and were included in the baseline analysis.
Arm/Group Title Standard Practice Standard Practice + Decision Aid
Hide Arm/Group Description Participants received education regarding treatment consideration from their healthcare provider/team as per standard practice (usual care). Participants received standard of care teaching and discussion in addition to web-based decision aid tool access.
Period Title: Overall Study
Started 60 60
Completed 18 28
Not Completed 42 32
Reason Not Completed
Lost to Follow-up             42             32
Arm/Group Title Standard Practice Standard Practice + Decision Aid Total
Hide Arm/Group Description Participants received education regarding treatment consideration from their healthcare provider/team as per standard practice (usual care). Participants received standard of care teaching and discussion in addition to web-based decision aid tool access. Total of all reporting groups
Overall Number of Baseline Participants 60 60 120
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants 60 participants 120 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
60
 100.0%
60
 100.0%
120
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants 60 participants 120 participants
Female
46
  76.7%
45
  75.0%
91
  75.8%
Male
14
  23.3%
15
  25.0%
29
  24.2%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants 60 participants 120 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
60
 100.0%
60
 100.0%
120
 100.0%
White
0
   0.0%
0
   0.0%
0
   0.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 60 participants 60 participants 120 participants
60
 100.0%
60
 100.0%
120
 100.0%
1.Primary Outcome
Title Acceptability of Decision Aid Education Assessed by the Acceptability Survey
Hide Description 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.
Time Frame Post Visit 1 (Up to 2 Weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was completed in both the standard practice and standard practice + decision aid groups together. There were a total of 106 participants who completed the survey.
Arm/Group Title Standard Practice and Standard Practice + Decision Aid Groups
Hide Arm/Group Description:
Participants received standard of care teaching and discussion. Participants received standard of care teaching and discussion in addition to web-based decision aid tool access.
Overall Number of Participants Analyzed 106
Median (Standard Deviation)
Unit of Measure: units on a scale
Health Impact of Sickle Cell Disease 3  (.86)
Risk Factors 3  (.97)
Research 3  (1.1)
Treatment Options 3  (1.1)
Evidence Supporting Self -Care 3  (1.1)
Hydroxyurea/BMT/CBT 3  (1.0)
Evidence About Hydroxyurea/BMT/CBT 3  (1.1)
Stories About Others 3  (.64)
2.Secondary Outcome
Title Mean Decisional Self-Efficacy Scale Score
Hide Description 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.
Time Frame Month 3, Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was completed for participants who completed the scale at month 3 and month 6 visits.
Arm/Group Title Standard Practice Standard Practice + Decision Aid
Hide Arm/Group Description:
Participants received education regarding treatment consideration from their healthcare provider/team as per standard practice (usual care).
Participants received standard of care teaching and discussion in addition to web-based decision aid tool access.
Overall Number of Participants Analyzed 11 16
Mean (Standard Deviation)
Unit of Measure: units on a scale
Month 3 59.29  (22.4) 75.31  (22.1)
Month 6 71.36  (29.97) 84.84  (16.39)
3.Secondary Outcome
Title Mean Difference in Decisional Conflict Scale Scores
Hide Description 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).
Time Frame Baseline, Month 3
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was completed for participants who completed the scale at both baseline and month 3 visits.
Arm/Group Title Standard Practice Standard Practice + Decision Aid
Hide Arm/Group Description:
Participants received education regarding treatment consideration from their healthcare provider/team as per standard practice (usual care).
Participants received standard of care teaching and discussion in addition to web-based decision aid tool access.
Overall Number of Participants Analyzed 20 22
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
Total Score
1.0
(-12.6 to 14.7)
4.8
(-15.6 to 6.0)
Uncertainty
.7
(-10.4 to 21.8)
1.9
(-9.4 to 13.2)
Informed
-1.3
(-19.2 to 16.5)
-12.1
(-23.3 to -1.0)
Values Clarity
-.001
(-16 to 16)
-8.0
(-21.4 to 5.5)
Support
-.4
(-16.3 to 15.4)
4.6
(-17.7 to 8.6)
Effective Decision
1.1
(-10.8 to 13.0)
2.3
(-14.2 to 9.7)
4.Secondary Outcome
Title Mean Difference in Decisional Conflict Scale Scores
Hide Description 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).
Time Frame Baseline, Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was completed for participants who completed the scale at both baseline and month 6 visits.
Arm/Group Title Standard Practice Standard Practice + Decision Aid
Hide Arm/Group Description:
Participants received education regarding treatment consideration from their healthcare provider/team as per standard practice (usual care).
Participants received standard of care teaching and discussion in addition to web-based decision aid tool access.
Overall Number of Participants Analyzed 16 20
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
Total Score
4.6
(-12.0 to 21.1)
-5.0
(-22.4 to 12.4)
Uncertainty
7.2
(-10.5 to 25.0)
.8
(-16.2 to 14.6)
Informed
1.7
(-18.7 to 22.0)
10.0
(-32.2 to 12.2)
Values Clarity
6.7
(-9.5 to 22.9)
-11.7
(-33.1 to 9.8)
Support
.6
(-18.2 to 19.4)
1.3
(-18.1 to 15.6)
Effective Decision
6.4
(-11.2 to 24.0)
-2.4
(-19.7 to 14.9)
5.Secondary Outcome
Title Mean Values Survey Score
Hide Description 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.
Time Frame Post Visit 1 (Up to 2 Weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis includes all participants who completed the survey.
Arm/Group Title Standard Practice Standard Practice + Decision Aid
Hide Arm/Group Description:
Participants received education regarding treatment consideration from their healthcare provider/team as per standard practice (usual care).
Participants received standard of care teaching and discussion in addition to web-based decision aid tool access.
Overall Number of Participants Analyzed 20 22
Mean (Standard Deviation)
Unit of Measure: units on a scale
10.2  (2) 10  (1.7)
6.Secondary Outcome
Title Mean Change in Preparation for Decision Making Scale Score
Hide Description 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.
Time Frame Month 3, Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis includes all participants who completed the survey.
Arm/Group Title Standard Practice Standard Practice + Decision Aid
Hide Arm/Group Description:
Participants received education regarding treatment consideration from their healthcare provider/team as per standard practice (usual care).
Participants received standard of care teaching and discussion in addition to web-based decision aid tool access.
Overall Number of Participants Analyzed 11 16
Mean (Standard Deviation)
Unit of Measure: units on a scale
.48  (.89) .38  (.74)
7.Secondary Outcome
Title Mean Knowledge Survey Scores
Hide Description 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%.
Time Frame Baseline, Month 3, Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis includes all participants who completed the survey.
Arm/Group Title Standard Practice Standard Practice + Decision Aid
Hide Arm/Group Description:
Participants received education regarding treatment consideration from their healthcare provider/team as per standard practice (usual care).
Participants received standard of care teaching and discussion in addition to web-based decision aid tool access.
Overall Number of Participants Analyzed 38 39
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 38  (49.87) 39  (49.83)
Month 3 19  (52.90) 23  (52.90)
Month 6 46.79  (51.18) 22  (55.54)
8.Secondary Outcome
Title Mean Decisional Regret Scale Score
Hide Description 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.
Time Frame Visit 3
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants who completed the scale.
Arm/Group Title Standard Practice + Decision Aid
Hide Arm/Group Description:
Participants received standard of care teaching and discussion in addition to web-based decision aid tool access.
Overall Number of Participants Analyzed 7
Mean (Standard Deviation)
Unit of Measure: units on a scale
27.5  (23.2)
Time Frame Adverse events were collected throughout the duration of the study (2 years).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Standard Practice Standard Practice + Decision Aid
Hide Arm/Group Description Participants received education regarding treatment consideration from their healthcare provider/team as per standard practice (usual care). Participants received standard of care teaching and discussion in addition to web-based decision aid tool access.
All-Cause Mortality
Standard Practice Standard Practice + Decision Aid
Affected / at Risk (%) Affected / at Risk (%)
Total   0/60 (0.00%)   0/60 (0.00%) 
Hide Serious Adverse Events
Standard Practice Standard Practice + Decision Aid
Affected / at Risk (%) Affected / at Risk (%)
Total   0/60 (0.00%)   0/60 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Standard Practice Standard Practice + Decision Aid
Affected / at Risk (%) Affected / at Risk (%)
Total   0/60 (0.00%)   0/60 (0.00%) 
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: Lakshmanan Krishnamurti, MD
Organization: Emory University
Phone: 4047270710
EMail: lkrishn@emory.edu
Publications:
Layout table for additonal information
Responsible Party: Lakshmanan Krishnamurti, Emory University
ClinicalTrials.gov Identifier: NCT02326597    
Other Study ID Numbers: IRB00076096a
First Submitted: December 18, 2014
First Posted: December 29, 2014
Results First Submitted: August 4, 2017
Results First Posted: October 9, 2018
Last Update Posted: October 9, 2018