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OpenTrials
Completed

NCT Number: NCT03253211

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.

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Key information

Conditions

Sickle Cell Disease Anemia Anemia, Hemolytic Anemia, Hemolytic, Congenital Anemia, Sickle Cell Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemoglobinopathies

Sex eligibility

All sexes

Study type

Observational

Primary location

Community Care of North Carolina

Raleigh, North Carolina, 27607, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • Agency for Healthcare Research and Quality (AHRQ)

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Aug 17, 2017
Registry last updated
Mar 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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