Disseminating NIH Evidence Based Sickle Cell Recommendations in North Carolina

NCT03253211 | Completed

• 1 other identifier: PRO00076048
• Study Type: observational
• Target: 4,392
• Locations: 1 country
• Sites: 1

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.

Conditions

Sickle Cell Disease

Keywords

Co-management model of care; Primary Care; Specialty Care; Decision support tools; Emergency Department Clinicians; Co-management

Outcome Measures

Primary Outcomes (2)

• HU refills

  number of hydroxyurea prescription refills per patient

  12 months

• Co-management visits

  number of co-management visits per patient

  12 months

Secondary Outcomes (7)

• ED visits

  12 months

• In-patient hospitalizations

  12 months

• Re-admission to hospital within 30 days

  12 months

• Primary care visits

  12 months

• Specialty visits

  12 months

Study Arms (4)

State

North Carolina

SCD Patients

Providers

Primary care and emergency department clinicians

Year

Baseline, year 2, year 3

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Duke University: lead
• Agency for Healthcare Research and Quality (AHRQ): collaborator

Study Sites (1)

Community Care of North Carolina

Raleigh, North Carolina, 27607, United States

Location

MeSH Terms

Conditions

Anemia, Sickle Cell

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Paula Tanabe, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2017
• First Posted: August 17, 2017
• Study Start: November 6, 2018
• Primary Completion: December 15, 2019
• Study Completion: December 15, 2019
• Last Updated: March 27, 2020

Record last verified: 2020-03

Locations

US (1)