Sickle Cell DiseaseSHiP HUNCT02197845
Enhancing Use of Hydroxyurea In Sickle Cell Disease Using Patient Navigators
A study testing Patient Navigator and Recruitment into Specialty Care in people with Sickle Cell Disease, run by Virginia Commonwealth University at 1 site in United States.
Trial summary
Multi-phase, patient navigator-based program in the Richmond and Tidewater regions of Virginia to demonstrate: 1. the feasibility of using patient navigators to improve the percentage of children and adult (age 15 and older) patients with sickle cell disease (SCD) in SCD specialty care 2. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Sickle Cell Disease
- What is being tested?
- Patient Navigator and Recruitment into Specialty Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 353 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2012to 31 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patient Self Report of Sickle Cell Disease (Genotypes: Hb SS, SC, SBoThal, SB+Thal)
- 15 years or older
- Virginia resident
- Sickle Cell Disease (SCD) patient (Genotypes: SS or SBoThal)
- Eligible for Hydroxyurea (according to NIH guidelines)
- 15 years or older
- Virginia resident
Who cannot join
- -Visited one of a pre-selected list of sickle cell specialists in Virginia within the last 6 months
- PHASE II:
- Pregnancy
- Enrollment in scheduled chronic transfusion program
- SCD Genotype: Hb SC and SB+Thal)
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University
Richmond, Virginia, 23298
About this study
Multi-phase, patient navigator-based program in the Richmond and Tidewater regions of Virginia to demonstrate:
- the feasibility of using patient navigators to improve the percentage of children and adult (age 15 and older) patients with sickle cell disease (SCD) in SCD specialty care
- the efficacy of using patient navigators to improve hydroxyurea (HU) (re-)initiation and adherence among adult patients with SCD eligible for HU (Patient navigators may also be known as public health workers.)
Read the detailed description
The state of Virginia, including the Virginia Department of Health and three academic medical centers and one federally qualified health center, plans a two-phase demonstration, first of improvement in the percentage of adults with SCD who are in SCD specialty care (Phase I), then of improvement in adherence to HU of eligible SCD adults (Phase II). Both phases will use existing academic SCD providers, and an innovative, multimodal strategy, featuring specially trained SCD patient navigators (PNs), that addresses barriers to care and to HU use. In Phase I we will demonstrate the feasibility of utilizing PNs to overcome patient access barriers to SCD care. In Phase II we will test the efficacy of PNs for overcoming barriers to acceptance of and adherence with HU therapy. Patients will be randomized to a PN arm or to a usual care arm. Providers will implement NIH guidelines for HU eligibility and prescribing in both arms. All HU eligible patients will be offered HU at each clinical visit. Among patients prescribed HU, if a maximum tolerated dose (MTD, defined in end points) has not been reached, providers will dose escalate every 8-12 weeks to MTD, rather than to clinical effect, before declaring treatment success or failure.
This project will be critically important and impactful by demonstrating the feasibility of a statewide community-based strategy to assist vulnerable SCD adults in obtaining SCD specialty care and likely prolonging life, a model that other states could adopt.
- Conditions
- Sickle Cell Disease
- Being tested
- Patient Navigator, Recruitment into Specialty Care
- Keywords
- sickle cell disease, hydroxyurea, patient navigator, community health worker, public health worker, fetal hemoglobin, health services research
- Medical subject headings
- Anemia, Sickle Cell, beta-Thalassemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient NavigatorBehavioural
Also called Public Health Worker, Community Health Worker
A specially trained (SCD knowledgable) Patient Navigator will act as a liaison who assists participants in increasing adherence to HU through disease education, addressing barriers to care and improving adherence to HU. PN utilize various techniques geared toward the individual patients needs. Interventions utilized by a PN include improving disease management skills, educational materials about disease, HU adherence, motivational interviewing, care coordination and social support.
Recruitment into Specialty CareBehavioural
Also called Sickle Cell Disease Specialty Care
A specially trained (SCD knowledgeable) Patient Navigator will act as a liaison to participants in increasing adherence to Hydroxyurea. Interventions utilized by a PN include teaching disease management skills, addressing barriers to care, disease education, HU management, motivational interviewing, care coordination and social support.
| Study group | Role | What they receive |
|---|---|---|
| Phase I: Recruitment into Specialty Care | Experimental | Participants in the Phase I Experimental Arm are enrolled into SCD specialty care. PN's will contact patient up to 3 times to assure patients have had an initial visit by 3 months time. Receives: Behavioral: Recruitment into Specialty Care |
| Phase II: Patient Navigator Arm | Experimental | Participants in the Phase II Experimental Arm follow routine clinical care and are assigned a Patient Navigator. A specially trained (SCD specefic)PN will work with participants for one year. Participants will be contacted by their Navigator weekly for the first 6 months, then biweekly for the second 6 months. Receives: Behavioral: Patient Navigator |
| Phase II: Passenger Arm | No intervention | No Intervention. Participants in the Phase II Passenger Arm follow routine clinical care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase I: Percent of enrolled Phase I subjects who complete a provider visit by 3 months post enrollment
Measured: 3 months
Phase II: Increase in fetal hemoglobin (HbF) as measured by hemoglobin electrophoresis
Measured: Baseline, 6 months, 1 year
Secondary outcomes (16)
Phase II: Measures of adherence to HU
For patients prescribed HU, clinical research coordinators will assess HU prescription refills from pill counts, pharmacy records, and self-report at baseline, 6 months, and 1 year. Patient navigators will regularly assess their patients' HU adherence by conducting pill counts at home visits.
Measured: Baseline, 6 months, 1 year
Phase II: Percent of patients achieving either maximum tolerated dose (MTD) or maximum dose
Maximum tolerated dose (MTD) is the daily single oral dose that can be maintained for at least 16 weeks without toxicity (< 3 x l09 neutrophils/L, <100 x l09 platelets/L, < 125 x l09 reticulocytes/L, 20% drop in [Hb] or an absolute value of <4.5 g/dL, 50% rise in creatinine or absolute increase of >0.4 mg/dL, 100% rise in ALT,GI disturbance, or rash or hair loss not attributable to other causes). Maximum dose is 35 mg/kg.
Measured: Baseline, 6 months, 1 year
Phase II: Number of emergency department and hospital visits
Measured: Baseline, 6 months, 1 year
Phase II: Mean corpuscular volume
Measured: Baseline, 6 months, 1 year
Phase II: Total hemoglobin
Measured: Baseline, 6 months, 1 year
Phase II: White blood cell count
Measured: Baseline, 6 months, 1 year
Phase II: Reticulocyte count
Measured: Baseline, 6 months, 1 year
Phase II: Quality of life measures
Adult Sickle Cell Quality of Life Measurement System (ASCQ-Me), Patient Reported Outcomes Measurement Information System (PROMIS)
Measured: Baseline, 6 months, 1 year
Phase II: Patient activation measures
Patient Activation Measure
Measured: Baseline, 6 months, 1 year
Phase II: Patient knowledge measures
Assessment of Sickle Cell Knowledge - University of Florida (UF-ASCK) (unpublished)
Measured: 1 year
Phase II: Health care knowledge and skills, self-efficacy, sickle cell stress measures
Sickle Cell Transition intervention Program (TIP) Survey (non-validated)
Measured: Baseline, 6 months, 1 year
Phase II: Social support measures
Sickle Cell Transition intervention Program (TIP) Survey (non-validated) and Multidimensional Scale of Perceived Social Support
Measured: Baseline, 6 months, 1 year
Phase II: Coping strategies
Coping Strategies Questionnaire for SCD
Measured: Baseline, 6 months, 1 year
Phase II: Associated pain conditions and comorbidities
Chart Review, Self Report and Surveys: Adult Sickle Cell Quality of Life Measurement System (ASCQ-Me), Patient Reported Outcomes Measurement Information System (PROMIS)
Measured: Baseline, 6 months, 1 year
Phase II: Blood transfusion measures (if applicable)
Chart review
Measured: 6 months, 1 year
Phase II: Patient Navigator Satisfaction (if applicable)
Patient Navigator Satisfaction Surveys, 12 month follow up, Patient Study Experience Review for Patient Navigators
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2014 (estimated)
- Study startOct 2012
- Primary completion7 Jul 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Sickle Cell DiseaseStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 353 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Collaborators
- Eastern Virginia Medical School, Children's Hospital of The King's Daughters, Virginia Department of Health, James Madison University, National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Wally R Smith, MD, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02197845
- Sponsor's protocol ID
- HM14641
- Other IDs
- 1R18HL112737-01
- Acronym
- SHiP HU
- Status last verified
- May 2023
- First submitted
- 21 Jul 2014
- Last updated
- 2 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
McClish D, Okhomina V, Pascale A, Valrie C, Sisler I, Villella A, Smith W. Vaso-occlusive crisis pain intensity, frequency, and duration: which best correlates with health-related quality of life in adolescents and adults with sickle cell disease? Pain. 2024 Jan 1;165(1):135-143. doi: 10.1097/j.pain.0000000000003011. Epub 2023 Aug 11.
PubMed 37578485Smith WR, Valrie C, Sisler I. Structural Racism and Impact on Sickle Cell Disease: Sickle Cell Lives Matter. Hematol Oncol Clin North Am. 2022 Dec;36(6):1063-1076. doi: 10.1016/j.hoc.2022.08.008.
PubMed 36400531Sisler I, McClish DK, Valrie C, Villella A, Smith WR. Satisfaction and access to care for adults and adolescents with sickle cell disease: ASCQ-Me quality of care and the SHIP-HU study. Pediatr Blood Cancer. 2022 Dec;69(12):e29948. doi: 10.1002/pbc.29948. Epub 2022 Sep 24.
PubMed 36151945
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Use of Hydroxyurea In Sickle Cell Disease Using Patient Navigators
- ClinicalTrials.gov ID
- NCT02197845
- Acronym / sponsor ID
- SHiP HU / HM14641
- Conditions
- Sickle Cell Disease
- Keywords
- sickle cell disease, hydroxyurea, patient navigator, community health worker, public health worker, fetal hemoglobin, health services research
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 353 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Collaborators
- Eastern Virginia Medical School, Children's Hospital of The King's Daughters, Virginia Department of Health, James Madison University, National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Oct 2012 (actual)
- Primary completion
- 7 Jul 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 23 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Multi-phase, patient navigator-based program in the Richmond and Tidewater regions of Virginia to demonstrate:
- the feasibility of using patient navigators to improve the percentage of children and adult (age 15 and older) patients with sickle cell disease (SCD) in SCD specialty care
- the efficacy of using patient navigators to improve hydroxyurea (HU) (re-)initiation and adherence among adult patients with SCD eligible for HU (Patient navigators may also be known as public health workers.)
Detailed description
The state of Virginia, including the Virginia Department of Health and three academic medical centers and one federally qualified health center, plans a two-phase demonstration, first of improvement in the percentage of adults with SCD who are in SCD specialty care (Phase I), then of improvement in adherence to HU of eligible SCD adults (Phase II). Both phases will use existing academic SCD providers, and an innovative, multimodal strategy, featuring specially trained SCD patient navigators (PNs), that addresses barriers to care and to HU use. In Phase I we will demonstrate the feasibility of utilizing PNs to overcome patient access barriers to SCD care. In Phase II we will test the efficacy of PNs for overcoming barriers to acceptance of and adherence with HU therapy. Patients will be randomized to a PN arm or to a usual care arm. Providers will implement NIH guidelines for HU eligibility and prescribing in both arms. All HU eligible patients will be offered HU at each clinical visit. Among patients prescribed HU, if a maximum tolerated dose (MTD, defined in end points) has not been reached, providers will dose escalate every 8-12 weeks to MTD, rather than to clinical effect, before declaring treatment success or failure.
This project will be critically important and impactful by demonstrating the feasibility of a statewide community-based strategy to assist vulnerable SCD adults in obtaining SCD specialty care and likely prolonging life, a model that other states could adopt.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Phase I: Recruitment into Specialty Care | Experimental | Behavioral: Recruitment into Specialty CareParticipants in the Phase I Experimental Arm are enrolled into SCD specialty care. PN's will contact patient up to 3 times to assure patients have had an initial visit by 3 months time. |
| Phase II: Patient Navigator Arm | Experimental | Behavioral: Patient NavigatorParticipants in the Phase II Experimental Arm follow routine clinical care and are assigned a Patient Navigator. A specially trained (SCD specefic)PN will work with participants for one year. Participants will be contacted by their Navigator weekly for the first 6 months, then biweekly for the second 6 months. |
| Phase II: Passenger Arm | No intervention | –No Intervention. Participants in the Phase II Passenger Arm follow routine clinical care. |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Patient Self Report of Sickle Cell Disease (Genotypes: Hb SS, SC, SBoThal, SB+Thal)
- 15 years or older
- Virginia resident
- Sickle Cell Disease (SCD) patient (Genotypes: SS or SBoThal)
- Eligible for Hydroxyurea (according to NIH guidelines)
Key exclusion criteria (5 listed)
- -Visited one of a pre-selected list of sickle cell specialists in Virginia within the last 6 months
- Pregnancy
- Enrollment in scheduled chronic transfusion program
- SCD Genotype: Hb SC and SB+Thal)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient NavigatorAlso: Public Health Worker, Community Health WorkerA specially trained (SCD knowledgable) Patient Navigator will act as a liaison who assists participants in increasing adherence to HU through disease education, addressing barriers to care and improving adherence to HU. PN utilize various techniques geared toward the individual patients needs. Interventions utilized by a PN include improving disease management skills, educational materials about disease, HU adherence, motivational interviewing, care coordination and social support. | Behavioural | Phase II: Patient Navigator Arm |
| Recruitment into Specialty CareAlso: Sickle Cell Disease Specialty CareA specially trained (SCD knowledgeable) Patient Navigator will act as a liaison to participants in increasing adherence to Hydroxyurea. Interventions utilized by a PN include teaching disease management skills, addressing barriers to care, disease education, HU management, motivational interviewing, care coordination and social support. | Behavioural | Phase I: Recruitment into Specialty Care |
Primary outcome
Phase I: Percent of enrolled Phase I subjects who complete a provider visit by 3 months post enrollment
Time frame: 3 months
Phase II: Increase in fetal hemoglobin (HbF) as measured by hemoglobin electrophoresis
Time frame: Baseline, 6 months, 1 year
16 secondary outcomes
Phase II: Measures of adherence to HU
Time frame: Baseline, 6 months, 1 year
Phase II: Percent of patients achieving either maximum tolerated dose (MTD) or maximum dose
Time frame: Baseline, 6 months, 1 year
Phase II: Number of emergency department and hospital visits
Time frame: Baseline, 6 months, 1 year
Phase II: Mean corpuscular volume
Time frame: Baseline, 6 months, 1 year
Phase II: Total hemoglobin
Time frame: Baseline, 6 months, 1 year
Phase II: White blood cell count
Time frame: Baseline, 6 months, 1 year
Phase II: Reticulocyte count
Time frame: Baseline, 6 months, 1 year
Phase II: Quality of life measures
Time frame: Baseline, 6 months, 1 year
Phase II: Patient activation measures
Time frame: Baseline, 6 months, 1 year
Phase II: Patient knowledge measures
Time frame: 1 year
Phase II: Health care knowledge and skills, self-efficacy, sickle cell stress measures
Time frame: Baseline, 6 months, 1 year
Phase II: Social support measures
Time frame: Baseline, 6 months, 1 year
Phase II: Coping strategies
Time frame: Baseline, 6 months, 1 year
Phase II: Associated pain conditions and comorbidities
Time frame: Baseline, 6 months, 1 year
Phase II: Blood transfusion measures (if applicable)
Time frame: 6 months, 1 year
Phase II: Patient Navigator Satisfaction (if applicable)
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2023.
- Derived from this study: PubMed 37578485McClish D, Okhomina V, Pascale A, Valrie C, Sisler I, Villella A, Smith W. Vaso-occlusive crisis pain intensity, frequency, and duration: which best correlates with health-related quality of life in adolescents and adults with sickle cell disease? Pain. 2024 Jan 1;165(1):135-143. doi: 10.1097/j.pain.0000000000003011. Epub 2023 Aug 11.
- Derived from this study: PubMed 36400531Smith WR, Valrie C, Sisler I. Structural Racism and Impact on Sickle Cell Disease: Sickle Cell Lives Matter. Hematol Oncol Clin North Am. 2022 Dec;36(6):1063-1076. doi: 10.1016/j.hoc.2022.08.008.
- Derived from this study: PubMed 36151945Sisler I, McClish DK, Valrie C, Villella A, Smith WR. Satisfaction and access to care for adults and adolescents with sickle cell disease: ASCQ-Me quality of care and the SHIP-HU study. Pediatr Blood Cancer. 2022 Dec;69(12):e29948. doi: 10.1002/pbc.29948. Epub 2022 Sep 24.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wally R Smith, MD principal investigator
Virginia Commonwealth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient Navigator and Recruitment into Specialty Care in people with Sickle Cell Disease, run by Virginia Commonwealth University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase I: Percent of enrolled Phase I subjects who complete a provider visit by 3 months post enrollment (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02197845, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2023.