Trial Outcomes & Findings for Shared-Decision Making for Hydroxyurea (NCT NCT03442114)
NCT ID: NCT03442114
Last Updated: 2025-06-13
Results Overview
Decisional Conflict Scale (DCS) is a 16-item parent-completed survey that measures uncertainty experienced when feeling uninformed about options, unclear about personal values, or unsupported in making a choice. Parents report their level of agreement with each item using a 5 point likert scale (0=strongly agree to 4=strongly disagree). For the total score, items are summed, divided by 16, and multiplied by 25. All subscores consist of 3 items except the Effective Decisions subcore (4 items) that are summed, divided by the number of items (3 or4) and multiplied by 25. Scores range from 0 (feels extremely certain about best choice) to 100 (feels extremely uncertain about best choice) on the total score and all subscores. Thus, a higher score indicates a high decisional conflict.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
176 participants
Primary outcome timeframe
Baseline - after shared discussion with clinician
Results posted on
2025-06-13
Participant Flow
Since children were 0-5 years of age, parents completed all measures and were considered study participants. Study participants were recruited based on how they met inclusion criteria assessed by Clinical Research Coordinators and approved by participating physicians at 12 academic medical centers between July 2018 and November 2021.
This study was originally designed as a stepped-wedge cluster randomized trial design. However, the study was amended to randomize participants instead of facilities, resulting in a parallel randomized controlled clinical trial. Of 176 enrolled participants,174 were allocated to either the Usual Care or Toolkit condition (quasi-experimental design), but only 137 completed the study. While parents completed the surveys and provided feedback, only children were enrolled in the study.
Participant milestones
| Measure |
Hydroxyurea Shared Decision Making Toolkit (H-SDM)
During the H-SDM toolkit condition, sites will develop methods for identifying Eligible Patients \& Monitoring Progress, have the opportunity to use Implementation Tools, and will use the Visit Decision Aids. The H-SDM toolkit has four visit decision aids to support parents in their decision about hydroxyurea: pre-visit brochure, in-visit issue card, after-visit booklet and video narratives {videos of parents telling their story about how they made a decision about hydroxyurea).
Hydroxyurea SDM Toolkit: Implementation tools and visit decision aids
|
Clinician Pocket Guide
In this condition, sites will provide current guidelines for offering hydroxyurea and use the American Society of Hematology (ASH) pocket guide as a reference. ASH developed 'The Hydroxyurea and Transfusion Therapy for the Treatment of Sickle Cell Disease' clinician pocket guide based on the National Heart, Lung, and Blood Institute's Evidence Based Management of Sickle Cell Disease: Expert Panel Report, 2014.'
Clinician Pocket Guide: current hydroxyurea protocol and ASH pocket guide
|
|---|---|---|
|
Overall Study
STARTED
|
94
|
80
|
|
Overall Study
COMPLETED
|
78
|
59
|
|
Overall Study
NOT COMPLETED
|
16
|
21
|
Reasons for withdrawal
| Measure |
Hydroxyurea Shared Decision Making Toolkit (H-SDM)
During the H-SDM toolkit condition, sites will develop methods for identifying Eligible Patients \& Monitoring Progress, have the opportunity to use Implementation Tools, and will use the Visit Decision Aids. The H-SDM toolkit has four visit decision aids to support parents in their decision about hydroxyurea: pre-visit brochure, in-visit issue card, after-visit booklet and video narratives {videos of parents telling their story about how they made a decision about hydroxyurea).
Hydroxyurea SDM Toolkit: Implementation tools and visit decision aids
|
Clinician Pocket Guide
In this condition, sites will provide current guidelines for offering hydroxyurea and use the American Society of Hematology (ASH) pocket guide as a reference. ASH developed 'The Hydroxyurea and Transfusion Therapy for the Treatment of Sickle Cell Disease' clinician pocket guide based on the National Heart, Lung, and Blood Institute's Evidence Based Management of Sickle Cell Disease: Expert Panel Report, 2014.'
Clinician Pocket Guide: current hydroxyurea protocol and ASH pocket guide
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
13
|
13
|
|
Overall Study
Physician Decision
|
2
|
2
|
|
Overall Study
Protocol Violation
|
0
|
2
|
|
Overall Study
Withdrawal by Subject
|
1
|
3
|
|
Overall Study
Guardianship Change
|
0
|
1
|
Baseline Characteristics
Baseline measure stratified into parents and children.
Baseline characteristics by cohort
| Measure |
Clinician Pocket Guide
n=166 Participants
In this condition, sites will provide current guidelines for offering hydroxyurea and use the American Society of Hematology (ASH) pocket guide as a reference. ASH developed 'The Hydroxyurea and Transfusion Therapy for the Treatment of Sickle Cell Disease' clinician pocket guide based on the National Heart, Lung, and Blood Institute's Evidence Based Management of Sickle Cell Disease: Expert Panel Report, 2014.'
Clinician Pocket Guide: current hydroxyurea protocol and ASH pocket guide
|
Hydroxyurea SDM Toolkit (H-SDM)
n=126 Participants
During the H-SDM toolkit condition, sites will develop methods for identifying Eligible Patients \& Monitoring Progress, have the opportunity to use Implementation Tools, and will use the Visit Decision Aids. The H-SDM toolkit has four visit decision aids to support parents in their decision about hydroxyurea: pre-visit brochure, in-visit issue card, after-visit booklet and video narratives {videos of parents telling their story about how they made a decision about hydroxyurea).
Hydroxyurea SDM Toolkit: Implementation tools and visit decision aids
|
Total
n=292 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
Parent/Guardian
|
30.00 years
STANDARD_DEVIATION 6.891 • n=83 Participants • Baseline measure stratified into parents and children.
|
30.32 years
STANDARD_DEVIATION 7.980 • n=63 Participants • Baseline measure stratified into parents and children.
|
30.13 years
STANDARD_DEVIATION 7.345 • n=146 Participants • Baseline measure stratified into parents and children.
|
|
Age, Continuous
Child
|
1.05 years
STANDARD_DEVIATION 1.333 • n=83 Participants • Baseline measure stratified into parents and children.
|
1.20 years
STANDARD_DEVIATION 1.547 • n=63 Participants • Baseline measure stratified into parents and children.
|
1.11 years
STANDARD_DEVIATION 1.425 • n=146 Participants • Baseline measure stratified into parents and children.
|
|
Sex: Female, Male
Parent/Guardian · Female
|
76 Participants
n=83 Participants • Gender data not collected for one child and one parent in the "H-SDM" Arm.
|
60 Participants
n=62 Participants • Gender data not collected for one child and one parent in the "H-SDM" Arm.
|
136 Participants
n=145 Participants • Gender data not collected for one child and one parent in the "H-SDM" Arm.
|
|
Sex: Female, Male
Parent/Guardian · Male
|
7 Participants
n=83 Participants • Gender data not collected for one child and one parent in the "H-SDM" Arm.
|
2 Participants
n=62 Participants • Gender data not collected for one child and one parent in the "H-SDM" Arm.
|
9 Participants
n=145 Participants • Gender data not collected for one child and one parent in the "H-SDM" Arm.
|
|
Sex: Female, Male
Child · Female
|
45 Participants
n=83 Participants • Gender data not collected for one child and one parent in the "H-SDM" Arm.
|
32 Participants
n=62 Participants • Gender data not collected for one child and one parent in the "H-SDM" Arm.
|
77 Participants
n=145 Participants • Gender data not collected for one child and one parent in the "H-SDM" Arm.
|
|
Sex: Female, Male
Child · Male
|
38 Participants
n=83 Participants • Gender data not collected for one child and one parent in the "H-SDM" Arm.
|
30 Participants
n=62 Participants • Gender data not collected for one child and one parent in the "H-SDM" Arm.
|
68 Participants
n=145 Participants • Gender data not collected for one child and one parent in the "H-SDM" Arm.
|
|
Race (NIH/OMB)
Parent/Guardian · American Indian or Alaska Native
|
0 Participants
n=83 Participants • Baseline measure stratified into parents and children.
|
0 Participants
n=63 Participants • Baseline measure stratified into parents and children.
|
0 Participants
n=146 Participants • Baseline measure stratified into parents and children.
|
|
Race (NIH/OMB)
Parent/Guardian · Asian
|
0 Participants
n=83 Participants • Baseline measure stratified into parents and children.
|
1 Participants
n=63 Participants • Baseline measure stratified into parents and children.
|
1 Participants
n=146 Participants • Baseline measure stratified into parents and children.
|
|
Race (NIH/OMB)
Parent/Guardian · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=83 Participants • Baseline measure stratified into parents and children.
|
0 Participants
n=63 Participants • Baseline measure stratified into parents and children.
|
0 Participants
n=146 Participants • Baseline measure stratified into parents and children.
|
|
Race (NIH/OMB)
Parent/Guardian · Black or African American
|
74 Participants
n=83 Participants • Baseline measure stratified into parents and children.
|
56 Participants
n=63 Participants • Baseline measure stratified into parents and children.
|
130 Participants
n=146 Participants • Baseline measure stratified into parents and children.
|
|
Race (NIH/OMB)
Parent/Guardian · White
|
1 Participants
n=83 Participants • Baseline measure stratified into parents and children.
|
1 Participants
n=63 Participants • Baseline measure stratified into parents and children.
|
2 Participants
n=146 Participants • Baseline measure stratified into parents and children.
|
|
Race (NIH/OMB)
Parent/Guardian · More than one race
|
6 Participants
n=83 Participants • Baseline measure stratified into parents and children.
|
3 Participants
n=63 Participants • Baseline measure stratified into parents and children.
|
9 Participants
n=146 Participants • Baseline measure stratified into parents and children.
|
|
Race (NIH/OMB)
Parent/Guardian · Unknown or Not Reported
|
2 Participants
n=83 Participants • Baseline measure stratified into parents and children.
|
2 Participants
n=63 Participants • Baseline measure stratified into parents and children.
|
4 Participants
n=146 Participants • Baseline measure stratified into parents and children.
|
|
Race (NIH/OMB)
Child · American Indian or Alaska Native
|
0 Participants
n=83 Participants • Baseline measure stratified into parents and children.
|
0 Participants
n=63 Participants • Baseline measure stratified into parents and children.
|
0 Participants
n=146 Participants • Baseline measure stratified into parents and children.
|
|
Race (NIH/OMB)
Child · Asian
|
0 Participants
n=83 Participants • Baseline measure stratified into parents and children.
|
0 Participants
n=63 Participants • Baseline measure stratified into parents and children.
|
0 Participants
n=146 Participants • Baseline measure stratified into parents and children.
|
|
Race (NIH/OMB)
Child · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=83 Participants • Baseline measure stratified into parents and children.
|
0 Participants
n=63 Participants • Baseline measure stratified into parents and children.
|
0 Participants
n=146 Participants • Baseline measure stratified into parents and children.
|
|
Race (NIH/OMB)
Child · Black or African American
|
79 Participants
n=83 Participants • Baseline measure stratified into parents and children.
|
57 Participants
n=63 Participants • Baseline measure stratified into parents and children.
|
136 Participants
n=146 Participants • Baseline measure stratified into parents and children.
|
|
Race (NIH/OMB)
Child · White
|
0 Participants
n=83 Participants • Baseline measure stratified into parents and children.
|
1 Participants
n=63 Participants • Baseline measure stratified into parents and children.
|
1 Participants
n=146 Participants • Baseline measure stratified into parents and children.
|
|
Race (NIH/OMB)
Child · More than one race
|
4 Participants
n=83 Participants • Baseline measure stratified into parents and children.
|
4 Participants
n=63 Participants • Baseline measure stratified into parents and children.
|
8 Participants
n=146 Participants • Baseline measure stratified into parents and children.
|
|
Race (NIH/OMB)
Child · Unknown or Not Reported
|
0 Participants
n=83 Participants • Baseline measure stratified into parents and children.
|
1 Participants
n=63 Participants • Baseline measure stratified into parents and children.
|
1 Participants
n=146 Participants • Baseline measure stratified into parents and children.
|
|
Region of Enrollment
United States
|
166 participants
n=166 Participants
|
126 participants
n=126 Participants
|
292 participants
n=292 Participants
|
PRIMARY outcome
Timeframe: Baseline - after shared discussion with clinicianPopulation: All parents with data for baseline measures (146) were included in the analyses, whether or not they attended the follow-up visit or completed additional measures.
Decisional Conflict Scale (DCS) is a 16-item parent-completed survey that measures uncertainty experienced when feeling uninformed about options, unclear about personal values, or unsupported in making a choice. Parents report their level of agreement with each item using a 5 point likert scale (0=strongly agree to 4=strongly disagree). For the total score, items are summed, divided by 16, and multiplied by 25. All subscores consist of 3 items except the Effective Decisions subcore (4 items) that are summed, divided by the number of items (3 or4) and multiplied by 25. Scores range from 0 (feels extremely certain about best choice) to 100 (feels extremely uncertain about best choice) on the total score and all subscores. Thus, a higher score indicates a high decisional conflict.
Outcome measures
| Measure |
Clinician Pocket Guide
n=83 Participants
In this condition, sites will provide current guidelines for offering hydroxyurea and use the American Society of Hematology (ASH) pocket guide as a reference. ASH developed 'The Hydroxyurea and Transfusion Therapy for the Treatment of Sickle Cell Disease' clinician pocket guide based on the National Heart, Lung, and Blood Institute's Evidence Based Management of Sickle Cell Disease: Expert Panel Report, 2014.'
Clinician Pocket Guide: current hydroxyurea protocol and ASH pocket guide
|
Hydroxyurea SDM Toolkit (H-SDM)
n=63 Participants
During the H-SDM toolkit condition, sites will develop methods for identifying Eligible Patients \& Monitoring Progress, have the opportunity to use Implementation Tools, and will use the Visit Decision Aids. The H-SDM toolkit has four visit decision aids to support parents in their decision about hydroxyurea: pre-visit brochure, in-visit issue card, after-visit booklet and video narratives {videos of parents telling their story about how they made a decision about hydroxyurea).
Hydroxyurea SDM Toolkit: Implementation tools and visit decision aids
|
|---|---|---|
|
Decisional Conflict
Support
|
21.2 score on a scale
Standard Deviation 24.4
|
17.9 score on a scale
Standard Deviation 16.8
|
|
Decisional Conflict
DCS Total Score
|
22.9 score on a scale
Standard Deviation 20.3
|
19.8 score on a scale
Standard Deviation 17.1
|
|
Decisional Conflict
Uncertainty
|
26.9 score on a scale
Standard Deviation 25.4
|
23.5 score on a scale
Standard Deviation 21.5
|
|
Decisional Conflict
Informed
|
20.8 score on a scale
Standard Deviation 20.2
|
16.8 score on a scale
Standard Deviation 14.4
|
|
Decisional Conflict
Values Clarity
|
23.3 score on a scale
Standard Deviation 24.4
|
21.0 score on a scale
Standard Deviation 21.1
|
|
Decisional Conflict
Effective Decisions
|
22.3 score on a scale
Standard Deviation 21.0
|
19.6 score on a scale
Standard Deviation 20.3
|
PRIMARY outcome
Timeframe: Baseline visit - after shared discussion with clinicianPopulation: 145 parents with data for baseline measures were included in the analyses whether or not they attended the follow-up visit or completed additional measures.
Dyadic OPTION describes clinician behaviors to involve a patient/parent in decision-making. A total score is calculated which ranges from 0 (no involvement) to 100 (maximal involvement). Dyadic OPTION scores correlate well with OPTION scale (Melbourne et al., 2011); 1 item "My doctor and I made the decision together"(Légaré et al., 2010). Higher scores indicate that the patient/parent has higher shared decision making competencies.
Outcome measures
| Measure |
Clinician Pocket Guide
n=82 Participants
In this condition, sites will provide current guidelines for offering hydroxyurea and use the American Society of Hematology (ASH) pocket guide as a reference. ASH developed 'The Hydroxyurea and Transfusion Therapy for the Treatment of Sickle Cell Disease' clinician pocket guide based on the National Heart, Lung, and Blood Institute's Evidence Based Management of Sickle Cell Disease: Expert Panel Report, 2014.'
Clinician Pocket Guide: current hydroxyurea protocol and ASH pocket guide
|
Hydroxyurea SDM Toolkit (H-SDM)
n=63 Participants
During the H-SDM toolkit condition, sites will develop methods for identifying Eligible Patients \& Monitoring Progress, have the opportunity to use Implementation Tools, and will use the Visit Decision Aids. The H-SDM toolkit has four visit decision aids to support parents in their decision about hydroxyurea: pre-visit brochure, in-visit issue card, after-visit booklet and video narratives {videos of parents telling their story about how they made a decision about hydroxyurea).
Hydroxyurea SDM Toolkit: Implementation tools and visit decision aids
|
|---|---|---|
|
Dyadic OPTION
|
39.8 score on a scale
Standard Deviation 6.7
|
40.3 score on a scale
Standard Deviation 5.8
|
SECONDARY outcome
Timeframe: From date of randomization until the date of first documented offering or prescription, whichever came first, assessed up to 7 monthsPopulation: 143 children with data for baseline measures were included in the analyses whether or not they attended the follow-up visit or completed additional measures.
1 of 3 responses - completed by the research coordinator based on review of electronic medical record (EMR) data: hydroxyurea was not offered, offered, or previously prescribed.
Outcome measures
| Measure |
Clinician Pocket Guide
n=83 Participants
In this condition, sites will provide current guidelines for offering hydroxyurea and use the American Society of Hematology (ASH) pocket guide as a reference. ASH developed 'The Hydroxyurea and Transfusion Therapy for the Treatment of Sickle Cell Disease' clinician pocket guide based on the National Heart, Lung, and Blood Institute's Evidence Based Management of Sickle Cell Disease: Expert Panel Report, 2014.'
Clinician Pocket Guide: current hydroxyurea protocol and ASH pocket guide
|
Hydroxyurea SDM Toolkit (H-SDM)
n=60 Participants
During the H-SDM toolkit condition, sites will develop methods for identifying Eligible Patients \& Monitoring Progress, have the opportunity to use Implementation Tools, and will use the Visit Decision Aids. The H-SDM toolkit has four visit decision aids to support parents in their decision about hydroxyurea: pre-visit brochure, in-visit issue card, after-visit booklet and video narratives {videos of parents telling their story about how they made a decision about hydroxyurea).
Hydroxyurea SDM Toolkit: Implementation tools and visit decision aids
|
|---|---|---|
|
Hydroxyurea Offered
Offered
|
61 Participants
|
32 Participants
|
|
Hydroxyurea Offered
Not Offered
|
19 Participants
|
25 Participants
|
|
Hydroxyurea Offered
Previously Prescribed
|
3 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Baseline after the shared discussionPopulation: 145 parents with data for baseline measures were included in the analyses whether or not they attended the follow-up visit or completed additional measures.
Eight-item survey adapted from the Satisfaction With Decision scale 41 (4 items) and the Agency for Healthcare Research and Quality's Consumer Assessment of Healthcare Providers and Systems survey related to patient experience of care (4 items). 42 Items are summed to obtain a total score ranging from 0 to 28, with higher scores indicating higher satisfaction.
Outcome measures
| Measure |
Clinician Pocket Guide
n=82 Participants
In this condition, sites will provide current guidelines for offering hydroxyurea and use the American Society of Hematology (ASH) pocket guide as a reference. ASH developed 'The Hydroxyurea and Transfusion Therapy for the Treatment of Sickle Cell Disease' clinician pocket guide based on the National Heart, Lung, and Blood Institute's Evidence Based Management of Sickle Cell Disease: Expert Panel Report, 2014.'
Clinician Pocket Guide: current hydroxyurea protocol and ASH pocket guide
|
Hydroxyurea SDM Toolkit (H-SDM)
n=63 Participants
During the H-SDM toolkit condition, sites will develop methods for identifying Eligible Patients \& Monitoring Progress, have the opportunity to use Implementation Tools, and will use the Visit Decision Aids. The H-SDM toolkit has four visit decision aids to support parents in their decision about hydroxyurea: pre-visit brochure, in-visit issue card, after-visit booklet and video narratives {videos of parents telling their story about how they made a decision about hydroxyurea).
Hydroxyurea SDM Toolkit: Implementation tools and visit decision aids
|
|---|---|---|
|
Satisfaction With Decision-Making
|
13.5 score on a scale
Standard Deviation 5.5
|
13.2 score on a scale
Standard Deviation 6.3
|
SECONDARY outcome
Timeframe: After discussion with clinicianPopulation: The data of 120 children with baseline measures were included in the analyses whether or not they attended the follow-up visit or completed additional measures.
This questionnaire is a reliable, accurate developmental and social-emotional screener for children between birth and 6 years of age, with a Cronbach α = .60 to .85. Scores range from 0 to 60, with higher scores indicating that the child's development is on schedule.
Outcome measures
| Measure |
Clinician Pocket Guide
n=75 Participants
In this condition, sites will provide current guidelines for offering hydroxyurea and use the American Society of Hematology (ASH) pocket guide as a reference. ASH developed 'The Hydroxyurea and Transfusion Therapy for the Treatment of Sickle Cell Disease' clinician pocket guide based on the National Heart, Lung, and Blood Institute's Evidence Based Management of Sickle Cell Disease: Expert Panel Report, 2014.'
Clinician Pocket Guide: current hydroxyurea protocol and ASH pocket guide
|
Hydroxyurea SDM Toolkit (H-SDM)
n=45 Participants
During the H-SDM toolkit condition, sites will develop methods for identifying Eligible Patients \& Monitoring Progress, have the opportunity to use Implementation Tools, and will use the Visit Decision Aids. The H-SDM toolkit has four visit decision aids to support parents in their decision about hydroxyurea: pre-visit brochure, in-visit issue card, after-visit booklet and video narratives {videos of parents telling their story about how they made a decision about hydroxyurea).
Hydroxyurea SDM Toolkit: Implementation tools and visit decision aids
|
|---|---|---|
|
Ages & Stages Questionnaire - Gross Motor Subscale
|
50.9 score on a scale
Standard Deviation 14.0
|
51.9 score on a scale
Standard Deviation 11.0
|
SECONDARY outcome
Timeframe: After shared discussion with clinicianPopulation: 121 children with data for baseline measures were included in the analyses whether or not they attended the follow-up visit or completed additional measures.
Parent report of sickle cell disease (SCD)-specific quality of life (QOL) and pain, as measured by the Pediatric Quality of Life (PedsQL) SCD Module, which assesses several domains of health-related quality of life (HRQOL), including pain impact, fatigue, pain management, emotions, communication, and treatment adherence. Scores range from 0 to 100, with higher scores indicating higher HRQOL or higher functioning.
Outcome measures
| Measure |
Clinician Pocket Guide
n=74 Participants
In this condition, sites will provide current guidelines for offering hydroxyurea and use the American Society of Hematology (ASH) pocket guide as a reference. ASH developed 'The Hydroxyurea and Transfusion Therapy for the Treatment of Sickle Cell Disease' clinician pocket guide based on the National Heart, Lung, and Blood Institute's Evidence Based Management of Sickle Cell Disease: Expert Panel Report, 2014.'
Clinician Pocket Guide: current hydroxyurea protocol and ASH pocket guide
|
Hydroxyurea SDM Toolkit (H-SDM)
n=47 Participants
During the H-SDM toolkit condition, sites will develop methods for identifying Eligible Patients \& Monitoring Progress, have the opportunity to use Implementation Tools, and will use the Visit Decision Aids. The H-SDM toolkit has four visit decision aids to support parents in their decision about hydroxyurea: pre-visit brochure, in-visit issue card, after-visit booklet and video narratives {videos of parents telling their story about how they made a decision about hydroxyurea).
Hydroxyurea SDM Toolkit: Implementation tools and visit decision aids
|
|---|---|---|
|
Pediatric Quality of Life Inventory - Sickle Cell Disease Module (Peds QL - SCD Module) - Total Score
|
82.5 score on a scale
Standard Deviation 15.5
|
82.0 score on a scale
Standard Deviation 15.5
|
SECONDARY outcome
Timeframe: After shared discussion with clinicianPopulation: 145 parents with data for baseline measures were included in the analyses whether or not they attended the follow-up visit or completed additional measures.
Eight-item survey developed based on the existing literature, the Ottawa Knowledge User Manual, and parent and clinician stakeholders and used in our pilot work. Items are summed to obtain a total score ranging from 0 to 9, with higher scores indicating more knowledge.
Outcome measures
| Measure |
Clinician Pocket Guide
n=82 Participants
In this condition, sites will provide current guidelines for offering hydroxyurea and use the American Society of Hematology (ASH) pocket guide as a reference. ASH developed 'The Hydroxyurea and Transfusion Therapy for the Treatment of Sickle Cell Disease' clinician pocket guide based on the National Heart, Lung, and Blood Institute's Evidence Based Management of Sickle Cell Disease: Expert Panel Report, 2014.'
Clinician Pocket Guide: current hydroxyurea protocol and ASH pocket guide
|
Hydroxyurea SDM Toolkit (H-SDM)
n=63 Participants
During the H-SDM toolkit condition, sites will develop methods for identifying Eligible Patients \& Monitoring Progress, have the opportunity to use Implementation Tools, and will use the Visit Decision Aids. The H-SDM toolkit has four visit decision aids to support parents in their decision about hydroxyurea: pre-visit brochure, in-visit issue card, after-visit booklet and video narratives {videos of parents telling their story about how they made a decision about hydroxyurea).
Hydroxyurea SDM Toolkit: Implementation tools and visit decision aids
|
|---|---|---|
|
Hydroxyurea Knowledge
|
6.3 score on a scale
Standard Deviation 1.7
|
6.1 score on a scale
Standard Deviation 1.5
|
Adverse Events
Clinician Pocket Guide
Serious events: 5 serious events
Other events: 3 other events
Deaths: 0 deaths
Hydroxyurea SDM Toolkit (H-SDM)
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Clinician Pocket Guide
n=94 participants at risk
In this condition, sites will provide current guidelines for offering hydroxyurea and use the American Society of Hematology (ASH) pocket guide as a reference. ASH developed 'The Hydroxyurea and Transfusion Therapy for the Treatment of Sickle Cell Disease' clinician pocket guide based on the National Heart, Lung, and Blood Institute's Evidence Based Management of Sickle Cell Disease: Expert Panel Report, 2014.'
Clinician Pocket Guide: current hydroxyurea protocol and ASH pocket guide
|
Hydroxyurea SDM Toolkit (H-SDM)
n=80 participants at risk
During the H-SDM toolkit condition, sites will develop methods for identifying Eligible Patients \& Monitoring Progress, have the opportunity to use Implementation Tools, and will use the Visit Decision Aids. The H-SDM toolkit has four visit decision aids to support parents in their decision about hydroxyurea: pre-visit brochure, in-visit issue card, after-visit booklet and video narratives {videos of parents telling their story about how they made a decision about hydroxyurea).
Hydroxyurea SDM Toolkit: Implementation tools and visit decision aids
|
|---|---|---|
|
Blood and lymphatic system disorders
Hospitalization
|
5.3%
5/94 • Number of events 5 • Clinical Research Coordinators reported any adverse event data that occurred for the child with sickle cell disease enrolled between baseline and follow-up visits, which took place anywhere between 3 to 7 months. Numbers reported are based on all children enrolled in the overall study, not just those with data available for analyses (n=146).
An adverse events survey was filled out by each participating site's Clinical Research Coordinator(s) during the follow-up visit. Mortality and Adverse Events were not monitored/assessed in the parent population.
|
1.2%
1/80 • Number of events 1 • Clinical Research Coordinators reported any adverse event data that occurred for the child with sickle cell disease enrolled between baseline and follow-up visits, which took place anywhere between 3 to 7 months. Numbers reported are based on all children enrolled in the overall study, not just those with data available for analyses (n=146).
An adverse events survey was filled out by each participating site's Clinical Research Coordinator(s) during the follow-up visit. Mortality and Adverse Events were not monitored/assessed in the parent population.
|
Other adverse events
| Measure |
Clinician Pocket Guide
n=94 participants at risk
In this condition, sites will provide current guidelines for offering hydroxyurea and use the American Society of Hematology (ASH) pocket guide as a reference. ASH developed 'The Hydroxyurea and Transfusion Therapy for the Treatment of Sickle Cell Disease' clinician pocket guide based on the National Heart, Lung, and Blood Institute's Evidence Based Management of Sickle Cell Disease: Expert Panel Report, 2014.'
Clinician Pocket Guide: current hydroxyurea protocol and ASH pocket guide
|
Hydroxyurea SDM Toolkit (H-SDM)
n=80 participants at risk
During the H-SDM toolkit condition, sites will develop methods for identifying Eligible Patients \& Monitoring Progress, have the opportunity to use Implementation Tools, and will use the Visit Decision Aids. The H-SDM toolkit has four visit decision aids to support parents in their decision about hydroxyurea: pre-visit brochure, in-visit issue card, after-visit booklet and video narratives {videos of parents telling their story about how they made a decision about hydroxyurea).
Hydroxyurea SDM Toolkit: Implementation tools and visit decision aids
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Blood and lymphatic system disorders
Emergency Department (ED) Visit
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1.1%
1/94 • Number of events 1 • Clinical Research Coordinators reported any adverse event data that occurred for the child with sickle cell disease enrolled between baseline and follow-up visits, which took place anywhere between 3 to 7 months. Numbers reported are based on all children enrolled in the overall study, not just those with data available for analyses (n=146).
An adverse events survey was filled out by each participating site's Clinical Research Coordinator(s) during the follow-up visit. Mortality and Adverse Events were not monitored/assessed in the parent population.
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1.2%
1/80 • Number of events 1 • Clinical Research Coordinators reported any adverse event data that occurred for the child with sickle cell disease enrolled between baseline and follow-up visits, which took place anywhere between 3 to 7 months. Numbers reported are based on all children enrolled in the overall study, not just those with data available for analyses (n=146).
An adverse events survey was filled out by each participating site's Clinical Research Coordinator(s) during the follow-up visit. Mortality and Adverse Events were not monitored/assessed in the parent population.
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Blood and lymphatic system disorders
ED visit for Vasoocclusive Sickle Cell Crisis
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0.00%
0/94 • Clinical Research Coordinators reported any adverse event data that occurred for the child with sickle cell disease enrolled between baseline and follow-up visits, which took place anywhere between 3 to 7 months. Numbers reported are based on all children enrolled in the overall study, not just those with data available for analyses (n=146).
An adverse events survey was filled out by each participating site's Clinical Research Coordinator(s) during the follow-up visit. Mortality and Adverse Events were not monitored/assessed in the parent population.
|
1.2%
1/80 • Number of events 1 • Clinical Research Coordinators reported any adverse event data that occurred for the child with sickle cell disease enrolled between baseline and follow-up visits, which took place anywhere between 3 to 7 months. Numbers reported are based on all children enrolled in the overall study, not just those with data available for analyses (n=146).
An adverse events survey was filled out by each participating site's Clinical Research Coordinator(s) during the follow-up visit. Mortality and Adverse Events were not monitored/assessed in the parent population.
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Blood and lymphatic system disorders
Hospitalization
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2.1%
2/94 • Number of events 2 • Clinical Research Coordinators reported any adverse event data that occurred for the child with sickle cell disease enrolled between baseline and follow-up visits, which took place anywhere between 3 to 7 months. Numbers reported are based on all children enrolled in the overall study, not just those with data available for analyses (n=146).
An adverse events survey was filled out by each participating site's Clinical Research Coordinator(s) during the follow-up visit. Mortality and Adverse Events were not monitored/assessed in the parent population.
|
0.00%
0/80 • Clinical Research Coordinators reported any adverse event data that occurred for the child with sickle cell disease enrolled between baseline and follow-up visits, which took place anywhere between 3 to 7 months. Numbers reported are based on all children enrolled in the overall study, not just those with data available for analyses (n=146).
An adverse events survey was filled out by each participating site's Clinical Research Coordinator(s) during the follow-up visit. Mortality and Adverse Events were not monitored/assessed in the parent population.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place