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

Completed

• Conditions: Sickle Cell Disease

• Registration Number: NCT03037021
• Lead Sponsor: Duke University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2016-12-14
• Study First Submitted QC: 2017-01-27
• Study First Posted: 2017-01-31
• Study Start: 2017-05-31
• Primary Completion: 2017-12-07
• Study Completion: 2017-12-07
• Status Verified: 2018-08
• Last Update Submitted: 2023-10-31
• Last Update Posted: 2023-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 213

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

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Exclusion Criteria

• Non-English speaking

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Barriers to specialty care as measured by Focus Groups./interviews	60 Minutes after focus group or interview	Qualitative analysis will be used to analyze interviews and focus groups.
Barriers to ED care as measured by Survey	Approximately 30-45 minutes	Descriptive statistics will be used to summarize the survey data.
Barriers to primary care as measured by Focus Groups./interviews	60 Minutes after focus group or interview	Qualitative analysis will be used to analyze interviews and focus groups.
Barriers to primary care as measured by Survey	Approximately 30-45 minutes	Descriptive statistics will be used to summarize the survey data.
Barriers to ED care as measured by Focus Groups./interviews	60 Minutes after focus group or interview	Qualitative analysis will be used to analyze interviews and focus groups.
Barriers to specialty care as measured by Survey	Approximately 30-45 minutes	Descriptive statistics will be used to summarize the survey data.

Trial Locations

Locations (1)

Duke University; 🇺🇸 Durham, North Carolina, United States