Sickle Cell DiseaseNCT03037021
Improving Sickle Cell Disease (SCD) Care Using Web-based Guidelines
An observational study of Sickle Cell Disease, run by Duke University at 1 site in United States.
Trial summary
The overall goal of this proposed project is to 1) increase co-management between sickle cell specialists and primary care providers (PCP's); 2) increase the use of hydroxyurea (HU) which prevents Vaso-Occlusive Episode (VOE), EDs and subsequent hospitalizations, and death; 3) identify and link patients not receiving… Read more about this study
- Who is it for?
- Ages 15 to 45 years
- Conditions the study is for
- Sickle Cell Disease
- How many people
- 213 participants
- Where
- 1 siteUnited States
- Study dates
- 31 May 2017to 7 Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 45 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: The target population includes 15-45 year olds with and SCD, parents of 15-20 year olds with SCD and healthcare providers of patients with SCD residing in 31 specified counties in Central North Carolina.
Who may be able to join
- SCD patients in the 31 geographic counties surrounding Duke with genotypes Hemoglobin SS, SC, Sβ° or, Sβ+.
- and -Parents of 15-20 year old SCD patients in the 31 geographic counties surrounding Duke with genotypes Hemoglobin SS, SC, Sβ° or Sβ+.
- and
- -Healthcare providers of sickle cell patients in the 31 geographic counties surrounding Duke
Who cannot join
- Non-English speaking
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Improving Sickle Cell Disease (SCD) Care Using Web-based Guidelines, Nurse Care Managers and Peer Mentors in Primary Care and Emergency Departments in Central North Carolina
The overall goal of this proposed project is to 1) increase co-management between sickle cell specialists and primary care providers (PCP's); 2) increase the use of hydroxyurea (HU) which prevents Vaso-Occlusive Episode (VOE), EDs and subsequent hospitalizations, and death; 3) identify and link patients not receiving primary or SCD specialty care to care, and 4) shift healthcare use from EDs and hospitalizations to primary and specialty co-management. Many persons with SCD experience a poor quality of life, serious medical complications and frequent painful events that require treatment from SCD specialty care, primary care and emergency department (ED) providers. There are two dominating models of care in the United States; neither are ideal. Many people with SCD have all of their healthcare needs addressed by sickle cell specialists who do not typically provide primary care and are often geographically distant from the patients' home. Other sickle cell patients receive all of their care in EDs. Both models are inadequate and result in an alarmingly high number of ED visits for many patients. Current care models are neither cost efficient nor promoting optimal patient outcomes. To improve outcomes, the investigators will implement a new model of care for SCD using nurse care managers, web based-interactive algorithms, and test if additional patient provided coaching can improve outcomes.
Read the detailed description
To inform the model, the investigators will conduct an initial in-depth multi-level assessment of the barriers to care and implementation of the NHLBI "Evidence-Based Management of Sickle Cell Disease". With barriers and facilitators identified at the patient, provider, healthcare organization and community levels, the investigators will develop another study evaluation interventions that may improve the barriers.
- Conditions
- Sickle Cell Disease
- Keywords
- Sickle Cell Disease, Needs Assessment, Barriers to care, Access to care, Primary care
- Medical subject headings
- Anemia, Sickle Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| SCD Adult Patients | Focus group or individual interview and survey | |
| SCD Adolescent Patients | Focus group or individual interview and survey | |
| SCD Healthcare Providers | Focus group or individual interview and survey | |
| Parents of SCD Adolescents | Focus group or individual interview and survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Barriers to primary care as measured by Focus Groups./interviews
Qualitative analysis will be used to analyze interviews and focus groups.
Measured: 60 Minutes after focus group or interview
Barriers to specialty care as measured by Focus Groups./interviews
Qualitative analysis will be used to analyze interviews and focus groups.
Measured: 60 Minutes after focus group or interview
Barriers to ED care as measured by Focus Groups./interviews
Qualitative analysis will be used to analyze interviews and focus groups.
Measured: 60 Minutes after focus group or interview
Barriers to primary care as measured by Survey
Descriptive statistics will be used to summarize the survey data.
Measured: Approximately 30-45 minutes
Barriers to specialty care as measured by Survey
Descriptive statistics will be used to summarize the survey data.
Measured: Approximately 30-45 minutes
Barriers to ED care as measured by Survey
Descriptive statistics will be used to summarize the survey data.
Measured: Approximately 30-45 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2017 (estimated)
- Study start31 May 2017
- Primary completion7 Dec 2017
- Study completion7 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sickle Cell DiseaseStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 213 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Paula Tanabe, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03037021
- Sponsor's protocol ID
- Pro00073506
- Other IDs
- 1U01HL133964-01
- Status last verified
- Aug 2018
- First submitted
- 14 Dec 2016
- Last updated
- 1 Nov 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Sickle Cell Disease (SCD) Care Using Web-based Guidelines, Nurse Care Managers and Peer Mentors in Primary Care and Emergency Departments in Central North Carolina
- ClinicalTrials.gov ID
- NCT03037021
- Acronym / sponsor ID
- Pro00073506
- Conditions
- Sickle Cell Disease
- Keywords
- Sickle Cell Disease, Needs Assessment, Barriers to care, Access to care, Primary care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 213 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 31 May 2017 (actual)
- Primary completion
- 7 Dec 2017 (actual)
- Study completion
- 7 Dec 2017 (actual)
- First posted
- 31 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overall goal of this proposed project is to 1) increase co-management between sickle cell specialists and primary care providers (PCP's); 2) increase the use of hydroxyurea (HU) which prevents Vaso-Occlusive Episode (VOE), EDs and subsequent hospitalizations, and death; 3) identify and link patients not receiving primary or SCD specialty care to care, and 4) shift healthcare use from EDs and hospitalizations to primary and specialty co-management. Many persons with SCD experience a poor quality of life, serious medical complications and frequent painful events that require treatment from SCD specialty care, primary care and emergency department (ED) providers. There are two dominating models of care in the United States; neither are ideal. Many people with SCD have all of their healthcare needs addressed by sickle cell specialists who do not typically provide primary care and are often geographically distant from the patients' home. Other sickle cell patients receive all of their care in EDs. Both models are inadequate and result in an alarmingly high number of ED visits for many patients. Current care models are neither cost efficient nor promoting optimal patient outcomes. To improve outcomes, the investigators will implement a new model of care for SCD using nurse care managers, web based-interactive algorithms, and test if additional patient provided coaching can improve outcomes.
Detailed description
To inform the model, the investigators will conduct an initial in-depth multi-level assessment of the barriers to care and implementation of the NHLBI "Evidence-Based Management of Sickle Cell Disease". With barriers and facilitators identified at the patient, provider, healthcare organization and community levels, the investigators will develop another study evaluation interventions that may improve the barriers.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| SCD Adult Patients | – | –Focus group or individual interview and survey |
| SCD Adolescent Patients | – | –Focus group or individual interview and survey |
| SCD Healthcare Providers | – | –Focus group or individual interview and survey |
| Parents of SCD Adolescents | – | –Focus group or individual interview and survey |
Who may qualify
- Ages
- 15 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- The target population includes 15-45 year olds with and SCD, parents of 15-20 year olds with SCD and healthcare providers of patients with SCD residing in 31 specified counties in Central North Carolina.
Key inclusion criteria (4 listed)
- SCD patients in the 31 geographic counties surrounding Duke with genotypes Hemoglobin SS, SC, Sβ° or, Sβ+.
- and -Parents of 15-20 year old SCD patients in the 31 geographic counties surrounding Duke with genotypes Hemoglobin SS, SC, Sβ° or Sβ+.
- and
- -Healthcare providers of sickle cell patients in the 31 geographic counties surrounding Duke
Key exclusion criteria (1 listed)
- Non-English speaking
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Barriers to primary care as measured by Focus Groups./interviews
Time frame: 60 Minutes after focus group or interview
Qualitative analysis will be used to analyze interviews and focus groups.
Barriers to specialty care as measured by Focus Groups./interviews
Time frame: 60 Minutes after focus group or interview
Qualitative analysis will be used to analyze interviews and focus groups.
Barriers to ED care as measured by Focus Groups./interviews
Time frame: 60 Minutes after focus group or interview
Qualitative analysis will be used to analyze interviews and focus groups.
Barriers to primary care as measured by Survey
Time frame: Approximately 30-45 minutes
Descriptive statistics will be used to summarize the survey data.
Barriers to specialty care as measured by Survey
Time frame: Approximately 30-45 minutes
Descriptive statistics will be used to summarize the survey data.
Barriers to ED care as measured by Survey
Time frame: Approximately 30-45 minutes
Descriptive statistics will be used to summarize the survey data.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paula Tanabe, PhD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sickle Cell Disease, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Barriers to primary care as measured by Focus Groups./interviews (time frame: 60 Minutes after focus group or interview). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2023.