Disseminating NIH Evidence Based Sickle Cell Recommendations in North Carolina

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.

Study Overview

• Status: Completed
• Conditions: 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
• Enrollment (Actual): 4392

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Raleigh, North Carolina, United States, 27607
      • Community Care of North Carolina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
State; North Carolina
SCD Patients
Providers; Primary care and emergency department clinicians
Year; Baseline, year 2, year 3

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HU refills	number of hydroxyurea prescription refills per patient	12 months
Co-management visits	number of co-management visits per patient	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ED visits	number of visits to the emergency department per patient	12 months
In-patient hospitalizations	number of in-patient hospitalizations per patient	12 months
Re-admission to hospital within 30 days	number of re-admissions per patient over the course of one year	12 months
Primary care visits	number of visits to primary care provider per patient	12 months
Specialty visits	number of specialty care visits per patient	12 months
Transcranial doppler screening	number of transcranial doppler screenings per patient	12 months
Opioid prescription fills	number of opioid prescription fill days per patient	12 months

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: Agency for Healthcare Research and Quality (AHRQ)
• Investigators: Principal Investigator: Paula Tanabe, PhD, Duke University

Study record dates

Study Major Dates

• Study Start (Actual): November 6, 2018
• Primary Completion (Actual): December 15, 2019
• Study Completion (Actual): December 15, 2019

Study Registration Dates

• First Submitted: August 2, 2017
• First Submitted That Met QC Criteria: August 15, 2017
• First Posted (Actual): August 17, 2017

Study Record Updates

• Last Update Posted (Actual): March 27, 2020
• Last Update Submitted That Met QC Criteria: March 25, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Primary Care; Specialty Care; Co-management model of care; Decision support tools; Emergency Department Clinicians; Co-management
• Additional Relevant MeSH Terms: Hematologic Diseases; Genetic Diseases, Inborn; Anemia; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Hemoglobinopathies; Anemia, Sickle Cell
• Other Study ID Numbers: PRO00076048