Disseminating NIH Evidence Based Sickle Cell Recommendations in North Carolina

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03253211
Recruitment Status : Recruiting
First Posted : August 17, 2017
Last Update Posted : November 12, 2018
Agency for Healthcare Research and Quality (AHRQ)
Information provided by (Responsible Party):
Duke University

Brief 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. 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.

Condition or disease
Sickle Cell Disease

Detailed Description:

The investigators will achieve the goals stated above through three aims.

  1. 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.
  2. 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.
  3. 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 Type : Observational
Estimated Enrollment : 2270 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Disseminating NIH Evidence Based Sickle Cell Recommendations in North Carolina
Actual Study Start Date : November 6, 2018
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine

North Carolina and South Carolina
SCD Patients
Primary care and emergency department clinicians
Baseline, year 2, year 3

Primary Outcome Measures :
  1. HU refills [ Time Frame: 12 months ]
    number of hydroxyurea prescription refills per patient

  2. Co-management visits [ Time Frame: 12 months ]
    number of co-management visits per patient

Secondary Outcome Measures :
  1. ED visits [ Time Frame: 12 months ]
    number of visits to the emergency department per patient

  2. In-patient hospitalizations [ Time Frame: 12 months ]
    number of in-patient hospitalizations per patient

  3. Re-admission to hospital within 30 days [ Time Frame: 12 months ]
    number of re-admissions per patient over the course of one year

  4. Primary care visits [ Time Frame: 12 months ]
    number of visits to primary care provider per patient

  5. Specialty visits [ Time Frame: 12 months ]
    number of specialty care visits per patient

  6. Transcranial doppler screening [ Time Frame: 12 months ]
    number of transcranial doppler screenings per patient

  7. Opioid prescription fills [ Time Frame: 12 months ]
    number of opioid prescription fill days per patient

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.

Inclusion Criteria:

  • patient with diagnosis of sickle cell disease, emergency department clinician, or primary care clinician in the state of NC or part of SC

Exclusion Criteria:

  • Non-English speaking, non-resident of NC or SC

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03253211

Contact: Paula Tanabe, PhD (919) 613-6038
Contact: Nirmish Shah, MD (919) 668-5178

United States, North Carolina
Community Care of North Carolina Recruiting
Raleigh, North Carolina, United States, 27607
Contact: Marian Earls         
Sponsors and Collaborators
Duke University
Agency for Healthcare Research and Quality (AHRQ)
Principal Investigator: Paula Tanabe, PhD Duke University

Responsible Party: Duke University Identifier: NCT03253211     History of Changes
Other Study ID Numbers: PRO00076048
First Posted: August 17, 2017    Key Record Dates
Last Update Posted: November 12, 2018
Last Verified: October 2018

Keywords provided by Duke University:
Co-management model of care
Primary Care
Specialty Care
Decision support tools
Emergency Department Clinicians

Additional relevant MeSH terms:
Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Hematologic Diseases
Genetic Diseases, Inborn