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Completed

NCT Number: NCT03037021

Improving Sickle Cell Disease (SCD) Care Using Web-based Guidelines

The overall goal of this proposed project is to 1) increase co-management between sickle cell specialists and primary care providers (PCP's); 2) increase the use of hydroxyurea (HU) which prevents Vaso-Occlusive Episode (VOE), EDs and subsequent hospitalizations, and death; 3) identify and link patients not receiving primary or SCD specialty care to care, and 4) shift healthcare use from EDs and hospitalizations to primary and specialty co-management. Many persons with SCD experience a poor quality of life, serious medical complications and frequent painful events that require treatment from SCD specialty care, primary care and emergency department (ED) providers. There are two dominating models of care in the United States; neither are ideal. Many people with SCD have all of their healthcare needs addressed by sickle cell specialists who do not typically provide primary care and are often geographically distant from the patients' home. Other sickle cell patients receive all of their care in EDs. Both models are inadequate and result in an alarmingly high number of ED visits for many patients. Current care models are neither cost efficient nor promoting optimal patient outcomes. To improve outcomes, the investigators will implement a new model of care for SCD using nurse care managers, web based-interactive algorithms, and test if additional patient provided coaching can improve outcomes.

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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

Age range

15 year–45 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Duke University

Durham, North Carolina, 27710, United States

About this study

To inform the model, the investigators will conduct an initial in-depth multi-level assessment of the barriers to care and implementation of the NHLBI "Evidence-Based Management of Sickle Cell Disease". With barriers and facilitators identified at the patient, provider, healthcare organization and community levels, the investigators will develop another study evaluation interventions that may improve the barriers.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • SCD patients in the 31 geographic counties surrounding Duke with genotypes Hemoglobin SS, SC, Sβ° or, Sβ+.

and -Parents of 15-20 year old SCD patients in the 31 geographic counties surrounding Duke with genotypes Hemoglobin SS, SC, Sβ° or Sβ+.

and

-Healthcare providers of sickle cell patients in the 31 geographic counties surrounding Duke

Exclusion criteria

  • Non-English speaking

Treatment and study plan

Primary outcomes

  1. Barriers to primary care as measured by Focus Groups./interviews

    Time frame: 60 Minutes after focus group or interview

    Qualitative analysis will be used to analyze interviews and focus groups.

  2. Barriers to specialty care as measured by Focus Groups./interviews

    Time frame: 60 Minutes after focus group or interview

    Qualitative analysis will be used to analyze interviews and focus groups.

  3. Barriers to ED care as measured by Focus Groups./interviews

    Time frame: 60 Minutes after focus group or interview

    Qualitative analysis will be used to analyze interviews and focus groups.

  4. Barriers to primary care as measured by Survey

    Time frame: Approximately 30-45 minutes

    Descriptive statistics will be used to summarize the survey data.

  5. Barriers to specialty care as measured by Survey

    Time frame: Approximately 30-45 minutes

    Descriptive statistics will be used to summarize the survey data.

  6. Barriers to ED care as measured by Survey

    Time frame: Approximately 30-45 minutes

    Descriptive statistics will be used to summarize the survey data.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)
  • National Institutes of Health (NIH)

Registry information

Official study title

Improving Sickle Cell Disease (SCD) Care Using Web-based Guidelines, Nurse Care Managers and Peer Mentors in Primary Care and Emergency Departments in Central North Carolina

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jan 31, 2017
Registry last updated
Nov 1, 2023

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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