Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03037021
Recruitment Status : Completed
First Posted : January 31, 2017
Last Update Posted : August 8, 2018
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
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.

Condition or disease
Sickle Cell Disease

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.

Layout table for study information
Study Type : Observational
Actual Enrollment : 213 participants
Observational Model: Other
Time Perspective: Prospective
Official 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
Actual Study Start Date : May 31, 2017
Actual Primary Completion Date : December 7, 2017
Actual Study Completion Date : December 7, 2017

Resource links provided by the National Library of Medicine


Group/Cohort
SCD Adult Patients
Focus group or individual interview and survey
SCD Adolescent Patients
Focus group or individual interview and survey
SCD Healthcare Providers
Focus group or individual interview and survey
Parents of SCD Adolescents
Focus group or individual interview and survey



Primary Outcome Measures :
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   15 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The target population includes 15-45 year olds with and SCD, parents of 15-20 year olds with SCD and healthcare providers of patients with SCD residing in 31 specified counties in Central North Carolina.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03037021


Locations
Layout table for location information
United States, North Carolina
Duke University
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Layout table for investigator information
Principal Investigator: Paula Tanabe, PhD Duke University

Layout table for additonal information
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT03037021     History of Changes
Other Study ID Numbers: Pro00073506
1U01HL133964-01 ( U.S. NIH Grant/Contract )
First Posted: January 31, 2017    Key Record Dates
Last Update Posted: August 8, 2018
Last Verified: August 2018

Keywords provided by Duke University:
Sickle Cell Disease
Needs Assessment
Barriers to care
Access to care
Primary care

Additional relevant MeSH terms:
Layout table for MeSH terms
Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn