Sickle Cell DiseaseNCT03253211
Disseminating NIH Evidence Based Sickle Cell Recommendations in North Carolina
An observational study of Sickle Cell Disease, run by Duke University at 1 site in United States.
Trial summary
This project will improve the efficiency and quality of healthcare for persons with sickle cell disease, an under-served and at risk population by implementing a co-management model of care. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Sickle Cell Disease
- How many people
- 4,392 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Nov 2018to 15 Dec 2019
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with a diagnosis of sickle cell disease (not trait) are eligible for inclusion. Additionally, we will survey primary care and emergency department clinicians. Patients must be from North Carolina or Georgetown, SC. Clinicians must practice in NC or SC.
Who may be able to join
- patient with diagnosis of sickle cell disease, emergency department clinician, or primary care clinician in the state of NC or part of SC
Who cannot join
- Non-English speaking, non-resident of NC or SC
Trial locations and contacts
1 site in 1 country.
United States1 site
Community Care of North Carolina
Raleigh, North Carolina, 27607
About this study
This project will improve the efficiency and quality of healthcare for persons with sickle cell disease, an under-served and at risk population by implementing a co-management model of care. Many patients with sickle cell disease (SCD) receive care primarily from specialty physicians and emergency departments (ED), thus resulting in a lack of primary care and a high number of ED visits and hospitalizations. The goal is to improve PCP and SCD specialist co-management. The overall purpose of this dissemination project is to evaluate utilization data, as well as patient and provider reported outcomes associated with the dissemination of a toolbox of decision support tools to PCP's and ED providers across NC and SC.
Read the detailed description
The investigators will achieve the goals stated above through three aims.
- Examine the effects of decision support tools on study outcomes during the 12 months prior to project start and across the 3.5 years of the project in NC and SC. The investigators will also determine which patient and practice level characteristics predict study outcomes.
- Evaluate individual provider-reported awareness, use and preference of health maintenance tables and algorithms amongst PCPs and ED providers in NC and SC at project start and yearly across the project. Additionally, the investigators will explore patient reported awareness of and satisfaction with co-management model of care in NC and SC.
- The investigators will conduct an exploratory cost analysis of the dissemination and implementation of the SCD co-management model and its effect on healthcare resource utilization.
- Conditions
- Sickle Cell Disease
- Keywords
- Co-management model of care, Primary Care, Specialty Care, Decision support tools, Emergency Department Clinicians, Co-management
- 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 |
|---|---|---|
| State | North Carolina | |
| SCD Patients | Not described | |
| Providers | Primary care and emergency department clinicians | |
| Year | Baseline, year 2, year 3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
HU refills
number of hydroxyurea prescription refills per patient
Measured: 12 months
Co-management visits
number of co-management visits per patient
Measured: 12 months
Secondary outcomes (7)
ED visits
number of visits to the emergency department per patient
Measured: 12 months
In-patient hospitalizations
number of in-patient hospitalizations per patient
Measured: 12 months
Re-admission to hospital within 30 days
number of re-admissions per patient over the course of one year
Measured: 12 months
Primary care visits
number of visits to primary care provider per patient
Measured: 12 months
Specialty visits
number of specialty care visits per patient
Measured: 12 months
Transcranial doppler screening
number of transcranial doppler screenings per patient
Measured: 12 months
Opioid prescription fills
number of opioid prescription fill days per patient
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2017
- Study start6 Nov 2018
- Primary completion15 Dec 2019
- Study completion15 Dec 2019
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4,392 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Sponsor
- Investigators
- Paula Tanabe, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03253211
- Sponsor's protocol ID
- PRO00076048
- Status last verified
- Mar 2020
- First submitted
- 2 Aug 2017
- Last updated
- 27 Mar 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Disseminating NIH Evidence Based Sickle Cell Recommendations in North Carolina
- ClinicalTrials.gov ID
- NCT03253211
- Acronym / sponsor ID
- PRO00076048
- Conditions
- Sickle Cell Disease
- Keywords
- Co-management model of care, Primary Care, Specialty Care, Decision support tools, Emergency Department Clinicians, Co-management
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,392 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Study start
- 6 Nov 2018 (actual)
- Primary completion
- 15 Dec 2019 (actual)
- Study completion
- 15 Dec 2019 (actual)
- First posted
- 17 Aug 2017 (actual)
- 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.
This project will improve the efficiency and quality of healthcare for persons with sickle cell disease, an under-served and at risk population by implementing a co-management model of care. Many patients with sickle cell disease (SCD) receive care primarily from specialty physicians and emergency departments (ED), thus resulting in a lack of primary care and a high number of ED visits and hospitalizations. The goal is to improve PCP and SCD specialist co-management. The overall purpose of this dissemination project is to evaluate utilization data, as well as patient and provider reported outcomes associated with the dissemination of a toolbox of decision support tools to PCP's and ED providers across NC and SC.
Detailed description
The investigators will achieve the goals stated above through three aims.
- Examine the effects of decision support tools on study outcomes during the 12 months prior to project start and across the 3.5 years of the project in NC and SC. The investigators will also determine which patient and practice level characteristics predict study outcomes.
- Evaluate individual provider-reported awareness, use and preference of health maintenance tables and algorithms amongst PCPs and ED providers in NC and SC at project start and yearly across the project. Additionally, the investigators will explore patient reported awareness of and satisfaction with co-management model of care in NC and SC.
- The investigators will conduct an exploratory cost analysis of the dissemination and implementation of the SCD co-management model and its effect on healthcare resource utilization.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| State | – | –North Carolina |
| SCD Patients | – | – |
| Providers | – | –Primary care and emergency department clinicians |
| Year | – | –Baseline, year 2, year 3 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with a diagnosis of sickle cell disease (not trait) are eligible for inclusion. Additionally, we will survey primary care and emergency department clinicians. Patients must be from North Carolina or Georgetown, SC. Clinicians must practice in NC or SC.
Key inclusion criteria (1 listed)
- patient with diagnosis of sickle cell disease, emergency department clinician, or primary care clinician in the state of NC or part of SC
Key exclusion criteria (1 listed)
- Non-English speaking, non-resident of NC or SC
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
HU refills
Time frame: 12 months
number of hydroxyurea prescription refills per patient
Co-management visits
Time frame: 12 months
number of co-management visits per patient
7 secondary outcomes
ED visits
Time frame: 12 months
In-patient hospitalizations
Time frame: 12 months
Re-admission to hospital within 30 days
Time frame: 12 months
Primary care visits
Time frame: 12 months
Specialty visits
Time frame: 12 months
Transcranial doppler screening
Time frame: 12 months
Opioid prescription fills
Time frame: 12 months
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 27 Mar 2020.
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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 1 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 27 Mar 2020. 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?
HU refills (time frame: 12 months). The study lists 2 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 27 Mar 2020.