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Study Detail

Study ID 1022
Name Improving ED Care Using Individualized Pain Plans
Contact Email paula.tanabe@duke.edu
Acronym SCDIC ALIGN
Period 2020 - 2022
Design Clinical Trial
Study PI Paula Tanabe
Institution Duke University
URL https://scdic.rti.org/ABOUT/Study-Protocols
CTGovID https://clinicaltrials.gov/ct2/show/NCT04584528
Funding Agency NHLBI
Grant Number 5U01HL133964-05
Overview The overall purpose of this 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 provide access to the IPP for both adult patients with SCD and their ED providers. The multisite study has 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 is available for all adult ED providers to use as their routine practice, and patients at affiliated local clinics are invited to participate and enroll in the study.
Focus Areas 1. Assess the overall effectiveness of EHR-embedded IPPs on improving patient and provider outcomes associated with pain treatment in the adult ED setting.
2. Assess the reach, adoption, implementation, and maintenance of the EHR-embedded IPP components and implementation strategies at each participating site.
3. Assess organizational readiness at the beginning of the implementation and barriers and facilitators to the use of EHR-embedded IPPs.
Outcomes 1. Change in Patient-perceived quality of ED pain treatment. [ Time Frame: Baseline, 96 hours ]
2. ED revisit rate as measured by EHR retrieval [ Time Frame: Day 7, Day 30 ]
3. Hospital readmission rate measured by EHR retrieval [ Time Frame: Day 7, Day 30 ]
4. Time to first dose of pain medication measured by EHR retrieval [ Time Frame: Baseline ]
Data Location RTI International
Biospecimen Available N/A
Data Consent De-identified data will be shared outside SCDIC; investigators must adhere to Data Use Agreement
Biospecimen Consent No sample
Contact Consent NA
Genomic Data No
Age Range 15-45
No. Participants 277
Inclusion Criteria 1. Age 18 years up to and including 45 years
2. English speaking
3. 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.
4. Access to a cellular/mobile smart phone with access to text messaging (either Android or iPhone acceptable)
5. At least one Vaso-Occlusive Episode (VOE) visit to participating site Emergency Department (ED) the past 90 days from enrollment
6. At least one visit at the study site sickle cell disease clinic within the past 12 months
7. Willing and cognitively able to give informed consent
8. Provides pain treatment in one of the participating study Emergency Departments for a patient participant with a qualified ED visit .
Exclusion Criteria Patient's sickle cell provider states patient should not have a protocol or should not be administered opioids
Data ElementVariables
Acute Anemic Episode
Aplastic Crisis
Bleeding
Other Blood Problem
Sickle Cell Disease pat_bi9
pat_bi9oth
Data ElementVariables
Adverse event
Death s1f5q02c
Disability Status
Hospitalization
Medical Event
Serious Adverse Event
Data ElementVariables
Abdominal Pain
General Pain
Headache
Management apt_bi14oth
pat_bii11
pat_bii12
pat_bii13
pat_bii14
pat_e6
pat_e7
pro_fb1
pro_fb1oth
pro_fb2
Pain Attack
Skeletal and Joint Pain
Data ElementVariables
Address
Age pat_bi5
Ethnic Group pat_bi8
Gender pat_bi6
pat_bi6oth
Language
National Origin
Nuclear Family
Race pat_bi7
Data ElementVariables
Facility Type center
pat_biii1_1
pat_biii4_1
pat_biv1_extr
pat_sd2
pat_se2
pro_sf2
Provider Type pro_f1e
pro_f1eoth
role
role_other
Quality of Care pat_d1
pat_d2
pat_d3
pat_e1
pat_e2
pat_e3
Visit pat_biii_calc_total_voe
pat_biii_total_voe
pat_biii2_1
pat_biii3_1
pat_biv2_extr
pat_biv3_extr
pat_biv4_extr
pat_sd1
pat_se1
pro_sf1
pro_sf1a
Data ElementVariables
Provider pro_f1a
pro_f1b
pro_f1both
pro_f1c
pro_f1d
pro_fa2
pro_fa3
pro_fa4
pro_fb5
pro_fb6
pro_fb7
pro_fb8
Resource Implementation q_1
q_10
q_11
q_12
q_13
q_14
q_15
q_16
q_17
q_18
q_19
q_2
q_20
q_21
q_22
q_23
q_24
q_25
q_26
q_27
q_28
q_29
q_3
q_30
q_31
q_32
q_33
q_34
q_35
q_36
q_37
q_38
q_39
q_4
q_40
q_41
q_42
q_43
q_44
q_45
q_46
q_47
q_48
q_49
q_5
q_50
q_51
q_52
q_53
q_54
q_55
q_56
q_57
q_58
q_59
q_6
q_60
q_61
q_62
q_63
q_64
q_7
q_8
q_9
Data ElementVariables
Final Diagnosis
Hospitalization pat_biii_calc_total_hosp
pat_biii_total_hosp
pat_biii6_1
pat_biv6_extr
ICU
Data ElementVariables
Technology Support pat_d4
pat_e4
pat_e5
pat_e8a
pat_e8b
pat_e8c
Data ElementVariables
Antibiotics
Asthma
Blood Medication History
Cardiovascular
Compliance
Current Medication
Depression Medication History
Hydroxyurea
Medication
Neurologic Medication History
Pain pat_bii13b
pat_bii15
pat_bii15a_1
pat_bii15a_1_oth
pat_bii15b_1
pat_bii15d_1
pat_bii15e_1
pat_bii15e_1_other
pat_biii5_1
pat_biv5_extr
pat_biv5aa_extr
pat_biv5aaoth_extr
pat_biv5ab_extr
pat_biv5ac_extr
pat_biv5ad_extr
pat_biv5ad_extr_other
pro_fb3
pro_fb3oth
pro_fb4
pro_fb4oth
SCD Medication
Sildenafil
Supplements
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