Sickle Cell DiseaseALIGNNCT04584528
Implementing an Individualized Pain Plan (IPP) for ED Treatment of VOE's in Sickle Cell Disease
A study testing Electronic Health Record (EHR) Embedded Individualized Pain Plan (IPP) in people with Sickle Cell Disease and Genetic Disease, run by Duke University at 8 sites in United States.
Trial summary
The overall purpose of this proposed study is to improve management of vaso-occlusive episodes (VOEs) in adult EDs. We aim to implement NHLBI recommendations for VOE treatment by embedding Individualized Pain Plans (IPPs) in the electronic health record (EHR). Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Sickle Cell Disease, Genetic Disease, Hematologic Diseases
- What is being tested?
- Electronic Health Record (EHR) Embedded Individualized Pain Plan (IPP)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 279 participants
- Where
- 8 sitesUnited States
- Study dates
- 27 Oct 2020to 1 Oct 2022
- 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 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Patient Inclusion Criteria:
- Age 18 years up to and including 45 years
- English speaking
- Confirmed SCD diagnoses . Confirmed is defined as supported by documentation in the medical record of a positive test for one of the following : Hb SS, Hb SC, Hb S -thalassemia, Hb SO, Hb SD, Hb SG, Hb SE, or Hb SF.
- Access to a cellular/mobile smart phone with access to text messaging (either Android or iPhone acceptable) .
- At least one Vaso-Occlusive Episode (VOE) visit to participating site Emergency Department (ED) the past 90 days from enrollment
- At least one visit at the study site sickle cell disease clinic within the past 12 months
- Willing and cognitively able to give informed consent
Patient Exclusion criteria:
- Patient's sickle cell provider states patient should not have a protocol or should not be administered opioids
Provider Inclusion Criteria:
- Provides pain treatment in one of the participating study Emergency Departments for a patient participant with a qualified ED visit .
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Georgia Regents University
Augusta, Georgia, 30912
Medical University of South Carolina
Charleston, South Carolina, 29425
University of Illinois
Chicago, Illinois, 60612
Duke University
Durham, North Carolina, 27710
St. Jude's
Memphis, Tennessee, 38105
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
University of California San Francisco
Oakland, California, 94609
Washington University
St Louis, Missouri, 63110
About this study
Official title: Improving SCD Care Using Web-based Guidelines, Nurse Care Managers and Peer Mentors in Primary Care and Emergency Departments in Central North Carolina
The overall purpose of this proposed study is to improve management of vaso-occlusive episodes (VOEs) in adult EDs. We aim to implement NHLBI recommendations for VOE treatment by embedding Individualized Pain Plans (IPPs) in the electronic health record (EHR). The EHR-embedded IPP will serve as a record of patients' SCD genotype and will include analgesic medication recommendations developed by the SCD provider. In this project, we will provide access to the IPP for both adult patients with SCD and ED providers. The proposed multisite study will use a pre-post study design, with a core set of mandatory intervention components and strategies for each participating site and optional components and strategies to allow for intervention adaptation to local needs and resources. The EHR-embedded IPP will be available for all adult ED providers to use as their routine practice, and patients will be invited to participate and enroll in the study. We will use a simplified Technology Acceptance Model to explain the use of the IPP and the RE-AIM framework to assess the Reach, Effectiveness, Adoption, Implementation, and Maintenance of the intervention.
Read the detailed description
The study aims are as follows:
Aim 1: Assess the overall effectiveness of EHR-embedded IPPs on improving patient and provider outcomes associated with pain treatment in the adult ED setting. We will evaluate the effectiveness of the intervention on both patients and providers using a pre-post study design.
Sub-aim 1.a. To examine effectiveness of the EHR-embedded IPP on improving patients' perceived quality of ED pain treatment. We hypothesize that among enrolled patients with at least one ED VOE visit during the intervention period, the perceived quality of ED pain treatment will increase by 0.5 standard deviation (primary outcome) after an ED VOE visit when compared with the last ED VOE visits made by these patients within 90 days before enrollment. We will measure change pre- and post-intervention in secondary patient outcomes, including hospital admission rate within 12 months, ED VOE revisit rate, ED VOE readmission rate, and time to first dosage of pain medication provided in the ED.
Sub-aim 1.b. To examine the effectiveness of the EHR-embedded IPP on improving providers' self-efficacy in treating pain for patients with SCD and perceived quality of ED pain treatment. We hypothesize that the intervention will increase providers' self-efficacy in treating VOEs and managing pain for patients with SCD when compared with self-efficacy before the intervention. We will also explore the effect of the intervention on ED providers' perceived quality of ED pain treatment.
Aim 2: Assess the reach, adoption, implementation, and maintenance of the EHR-embedded IPP components and implementation strategies at each participating site. We will use the RE-AIM framework to evaluate intervention outcomes in addition to intervention effectiveness.
Sub-aim 2.a. To assess the reach of the EHR-embedded IPP. We will assess the reach of the intervention at the patient level by examining the proportion of patients enrolled in the study among all patients the team has reached out to recruit, and at the clinic level by examining the proportion of clinics participating in the intervention.
Sub-aim 2.b. To assess the adoption and implementation of the EHR-embedded IPP and track implementation strategies adopted by each site. We will assess the adoption of the intervention by examining characteristics of individual EDs that participate relative to the number of individual EDs affiliated with each study site who could have been recruited. We will assess implementation fidelity and outcomes, such as the proportion of eligible hematologists and nurse practitioners who receive IPP training, number of IPPs written and included in the EHR, required and optional intervention elements that are implemented as planned, IPP use by patients and providers, provider IPP adherence, and patients' and providers' perceived ease of use of the IPPs. We will track and report strategies used by participating sites through both quantitative data collection and qualitative interviews.
Sub-aim 2.c. To assess the intent to continue using the IPP from a multi-stakeholder perspective. We will assess patients' and providers' intent to continue using the IPP during the implementation period. At the end of the intervention, we will assess ED administrators' intent to continue using the IPP.
Aim 3: Assess organizational readiness at the beginning of the implementation and barriers and facilitators to the use of EHR-embedded IPPs. We will perform a Readiness Assessment to measure organization- and staff-level readiness at the beginning of the intervention to inform the selection and adaptation of implementation strategies. We will assess facilitators and barriers in adopting and implementing the IPPs from multiple stakeholder perspectives: patients, providers, and ED administrators.
Embedding IPPs in the EHR that are accessible to both ED providers and patients is a promising intervention to support the NHLBI evidence-based recommendations to guide treatment of VOE in the ED setting and improve quality of pain treatment in the ED and better patient outcomes. If EHR-embedded IPPs implemented and evaluated in this study show preliminary effectiveness, they could be scaled up within SCDIC Centers and expanded to other institutions outside the SCDIC. The results of this proposed study will accelerate the uptake of the NHLBI recommendation and establish standardized treatment in EDs for patients with SCD.
- Being tested
- Electronic Health Record (EHR) Embedded Individualized Pain Plan (IPP)
- Keywords
- sickle cell disease, vaso occlusive-episodes, Individualized Pain Plans, implementation science
- Medical subject headings
- Anemia, Sickle Cell, Genetic Diseases, Inborn, Hematologic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electronic Health Record (EHR) Embedded Individualized Pain Plan (IPP)Other
The IPPs will be developed by the Sickle Cell Disease providers at each study site based on patients' outpatient chronic opioid use and analgesic agent normally required for treatment of VOE in the ED. The Sickle Cell Disease provider will review the IPP with the patient, then upload the IPP to the patient's EHR in a location that will be accessible by the patient and ED provider. Each participating site will train patients and Emergency Department (ED) providers on how to access the IPP in the Electronic Health Record. The following required elements will be included in the EHR-embedded IPP:
- Genotype
- Individual pain plan-preferred analgesic agent, route, dose and dosing interval, last update time
- Name and contact information for the SCD provider
If the enrolled patient has a VOE visit at a nonparticipating ED, the patient will be able to access their IPP via the web or the patient portal app through their EHR. However, data will not be collected from these visits.
| Study group | Role | What they receive |
|---|---|---|
| EHR-embedded Individualized Pain Plan (IPP) | Other | The EHR embedded IPP will be made accessible to patients and ED providers at each study site. Receives: Other: Electronic Health Record (EHR) Embedded Individualized Pain Plan (IPP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Patient-perceived quality of ED pain treatment.
Three questions from the Adult Sickle Cell Quality of Life Measure (ASCQ-Me) and Quality of Care (QOC) measure will be used to measure the patient perceived quality of ED pain treatment
Measured: Baseline, 96 hours
Secondary outcomes (5)
ED revisit rate as measured by EHR retrieval
Measured: Day 7
ED revisit rate as measured by EHR retrieval
Measured: Day 30
Hospital readmission rate measured by EHR retrieval
Measured: Day 7
Hospital readmission rate measured by EHR retrieval
Measured: Day 30
Time to first dose of pain medication measured by EHR retrieval
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2020
- Study start27 Oct 2020
- Primary completion20 Sep 2022
- Study completion1 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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 Duke 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- Multi-site pre-post study design, with a core set of mandatory patient and provider intervention strategies for each participating site, and optional strategies to allow for intervention adaptation to local needs and resources.
- Masking
- None (open label)
- Enrolment
- 279 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), RTI International
- Responsible party
- Sponsor
- Investigators
- Paula Tanabe, PhD, Principal investigator, Duke University School of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04584528
- Sponsor's protocol ID
- Pro00073506_1
- Other IDs
- 5U01HL133964-05
- Acronym
- ALIGN
- Status last verified
- Oct 2022
- First submitted
- 6 Oct 2020
- Last updated
- 28 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified patient-level data will be available to researchers outside the SCDIC through an application and approval process as part of the SCDIC's Ancillary Studies Policy and Data Dissemination Plan. To protect the confidentiality and privacy of the participants, investigators granted access to the limited access data must adhere to strict requirements incorporated into a standard Data Use Agreement. In accordance with NHLBI policy, outside researchers will also be required to submit an approval tot RTI, the Data Coordinating Center, from their IRB.
Publications
Siewny L, King A, Melvin CL, Carpenter CR, Hankins JS, Colla JS, Preiss L, Luo L, Cox L, Treadwell M, Davila N, Masese RV, McCuskee S, Gollan SS, Tanabe P. Impact of an individualized pain plan to treat sickle cell disease vaso-occlusive episodes in the emergency department. Blood Adv. 2024 Oct 22;8(20):5330-5338. doi: 10.1182/bloodadvances.2023012439.
PubMed 38815230Luo L, King AA, Carroll Y, Baumann AA, Brambilla D, Carpenter CR, Colla J, Gibson RW, Gollan S, Hall G, Klesges L, Kutlar A, Lyon M, Melvin CL, Norell S, Mueller M, Potter MB, Richesson R, Richardson LD, Ryan G, Siewny L, Treadwell M, Zun L, Armstrong-Brown J, Cox L, Tanabe P. Electronic Health Record-Embedded Individualized Pain Plans for Emergency Department Treatment of Vaso-occlusive Episodes in Adults With Sickle Cell Disease: Protocol for a Preimplementation and Postimplementation Study. JMIR Res Protoc. 2021 Apr 16;10(4):e24818. doi: 10.2196/24818.
PubMed 33861209
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving SCD Care Using Web-based Guidelines, Nurse Care Managers and Peer Mentors in Primary Care and Emergency Departments in Central North Carolina
- ClinicalTrials.gov ID
- NCT04584528
- Acronym / sponsor ID
- ALIGN / Pro00073506_1
- Keywords
- sickle cell disease, vaso occlusive-episodes, Individualized Pain Plans, implementation science
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 279 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), RTI International
- Study start
- 27 Oct 2020 (actual)
- Primary completion
- 20 Sep 2022 (actual)
- Study completion
- 1 Oct 2022 (actual)
- First posted
- 14 Oct 2020 (actual)
- 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.
The overall purpose of this proposed study is to improve management of vaso-occlusive episodes (VOEs) in adult EDs. We aim to implement NHLBI recommendations for VOE treatment by embedding Individualized Pain Plans (IPPs) in the electronic health record (EHR). The EHR-embedded IPP will serve as a record of patients' SCD genotype and will include analgesic medication recommendations developed by the SCD provider. In this project, we will provide access to the IPP for both adult patients with SCD and ED providers. The proposed multisite study will use a pre-post study design, with a core set of mandatory intervention components and strategies for each participating site and optional components and strategies to allow for intervention adaptation to local needs and resources. The EHR-embedded IPP will be available for all adult ED providers to use as their routine practice, and patients will be invited to participate and enroll in the study. We will use a simplified Technology Acceptance Model to explain the use of the IPP and the RE-AIM framework to assess the Reach, Effectiveness, Adoption, Implementation, and Maintenance of the intervention.
Detailed description
The study aims are as follows:
Aim 1: Assess the overall effectiveness of EHR-embedded IPPs on improving patient and provider outcomes associated with pain treatment in the adult ED setting. We will evaluate the effectiveness of the intervention on both patients and providers using a pre-post study design.
Sub-aim 1.a. To examine effectiveness of the EHR-embedded IPP on improving patients' perceived quality of ED pain treatment. We hypothesize that among enrolled patients with at least one ED VOE visit during the intervention period, the perceived quality of ED pain treatment will increase by 0.5 standard deviation (primary outcome) after an ED VOE visit when compared with the last ED VOE visits made by these patients within 90 days before enrollment. We will measure change pre- and post-intervention in secondary patient outcomes, including hospital admission rate within 12 months, ED VOE revisit rate, ED VOE readmission rate, and time to first dosage of pain medication provided in the ED.
Sub-aim 1.b. To examine the effectiveness of the EHR-embedded IPP on improving providers' self-efficacy in treating pain for patients with SCD and perceived quality of ED pain treatment. We hypothesize that the intervention will increase providers' self-efficacy in treating VOEs and managing pain for patients with SCD when compared with self-efficacy before the intervention. We will also explore the effect of the intervention on ED providers' perceived quality of ED pain treatment.
Aim 2: Assess the reach, adoption, implementation, and maintenance of the EHR-embedded IPP components and implementation strategies at each participating site. We will use the RE-AIM framework to evaluate intervention outcomes in addition to intervention effectiveness.
Sub-aim 2.a. To assess the reach of the EHR-embedded IPP. We will assess the reach of the intervention at the patient level by examining the proportion of patients enrolled in the study among all patients the team has reached out to recruit, and at the clinic level by examining the proportion of clinics participating in the intervention.
Sub-aim 2.b. To assess the adoption and implementation of the EHR-embedded IPP and track implementation strategies adopted by each site. We will assess the adoption of the intervention by examining characteristics of individual EDs that participate relative to the number of individual EDs affiliated with each study site who could have been recruited. We will assess implementation fidelity and outcomes, such as the proportion of eligible hematologists and nurse practitioners who receive IPP training, number of IPPs written and included in the EHR, required and optional intervention elements that are implemented as planned, IPP use by patients and providers, provider IPP adherence, and patients' and providers' perceived ease of use of the IPPs. We will track and report strategies used by participating sites through both quantitative data collection and qualitative interviews.
Sub-aim 2.c. To assess the intent to continue using the IPP from a multi-stakeholder perspective. We will assess patients' and providers' intent to continue using the IPP during the implementation period. At the end of the intervention, we will assess ED administrators' intent to continue using the IPP.
Aim 3: Assess organizational readiness at the beginning of the implementation and barriers and facilitators to the use of EHR-embedded IPPs. We will perform a Readiness Assessment to measure organization- and staff-level readiness at the beginning of the intervention to inform the selection and adaptation of implementation strategies. We will assess facilitators and barriers in adopting and implementing the IPPs from multiple stakeholder perspectives: patients, providers, and ED administrators.
Embedding IPPs in the EHR that are accessible to both ED providers and patients is a promising intervention to support the NHLBI evidence-based recommendations to guide treatment of VOE in the ED setting and improve quality of pain treatment in the ED and better patient outcomes. If EHR-embedded IPPs implemented and evaluated in this study show preliminary effectiveness, they could be scaled up within SCDIC Centers and expanded to other institutions outside the SCDIC. The results of this proposed study will accelerate the uptake of the NHLBI recommendation and establish standardized treatment in EDs for patients with SCD.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Multi-site pre-post study design, with a core set of mandatory patient and provider intervention strategies for each participating site, and optional strategies to allow for intervention adaptation to local needs and resources.
| Arm | Type | Receives |
|---|---|---|
| EHR-embedded Individualized Pain Plan (IPP) | Other | Other: Electronic Health Record (EHR) Embedded Individualized Pain Plan (IPP)The EHR embedded IPP will be made accessible to patients and ED providers at each study site. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
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 |
|---|---|---|
| Electronic Health Record (EHR) Embedded Individualized Pain Plan (IPP)The IPPs will be developed by the Sickle Cell Disease providers at each study site based on patients' outpatient chronic opioid use and analgesic agent normally required for treatment of VOE in the ED. The Sickle Cell Disease provider will review the IPP with the patient, then upload the IPP to the patient's EHR in a location that will be accessible by the patient and ED provider. Each participating site will train patients and Emergency Department (ED) providers on how to access the IPP in the Electronic Health Record. The following required elements will be included in the EHR-embedded IPP: * Genotype * Individual pain plan-preferred analgesic agent, route, dose and dosing interval, last update time * Name and contact information for the SCD provider If the enrolled patient has a VOE visit at a nonparticipating ED, the patient will be able to access their IPP via the web or the patient portal app through their EHR. However, data will not be collected from these visits. | Other | EHR-embedded Individualized Pain Plan (IPP) |
Primary outcome
Change in Patient-perceived quality of ED pain treatment.
Time frame: Baseline, 96 hours
Three questions from the Adult Sickle Cell Quality of Life Measure (ASCQ-Me) and Quality of Care (QOC) measure will be used to measure the patient perceived quality of ED pain treatment
5 secondary outcomes
ED revisit rate as measured by EHR retrieval
Time frame: Day 7
ED revisit rate as measured by EHR retrieval
Time frame: Day 30
Hospital readmission rate measured by EHR retrieval
Time frame: Day 7
Hospital readmission rate measured by EHR retrieval
Time frame: Day 30
Time to first dose of pain medication measured by EHR retrieval
Time frame: Baseline
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 28 Oct 2022.
- Derived from this study: PubMed 38815230Siewny L, King A, Melvin CL, Carpenter CR, Hankins JS, Colla JS, Preiss L, Luo L, Cox L, Treadwell M, Davila N, Masese RV, McCuskee S, Gollan SS, Tanabe P. Impact of an individualized pain plan to treat sickle cell disease vaso-occlusive episodes in the emergency department. Blood Adv. 2024 Oct 22;8(20):5330-5338. doi: 10.1182/bloodadvances.2023012439.
- Derived from this study: PubMed 33861209Luo L, King AA, Carroll Y, Baumann AA, Brambilla D, Carpenter CR, Colla J, Gibson RW, Gollan S, Hall G, Klesges L, Kutlar A, Lyon M, Melvin CL, Norell S, Mueller M, Potter MB, Richesson R, Richardson LD, Ryan G, Siewny L, Treadwell M, Zun L, Armstrong-Brown J, Cox L, Tanabe P. Electronic Health Record-Embedded Individualized Pain Plans for Emergency Department Treatment of Vaso-occlusive Episodes in Adults With Sickle Cell Disease: Protocol for a Preimplementation and Postimplementation Study. JMIR Res Protoc. 2021 Apr 16;10(4):e24818. doi: 10.2196/24818.
- Individual participant dataSharing planned: Yes. De-identified patient-level data will be available to researchers outside the SCDIC through an application and approval process as part of the SCDIC's Ancillary Studies Policy and Data Dissemination Plan. To protect the confidentiality and privacy of the participants, investigators granted access to the limited access data must adhere to strict requirements incorporated into a standard Data Use Agreement. In accordance with NHLBI policy, outside researchers will also be required to submit an approval tot RTI, the Data Coordinating Center, from their IRB.
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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.
Paula Tanabe, PhD principal investigator
Duke University School of Nursing
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electronic Health Record (EHR) Embedded Individualized Pain Plan (IPP) in people with Sickle Cell Disease and Genetic Disease, run by Duke University at 8 sites 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?
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 28 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites 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?
Change in Patient-perceived quality of ED pain treatment. (time frame: Baseline, 96 hours). 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 NCT04584528, which also lists 2 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 28 Oct 2022.