Creating a multi-level intervention to reduce stigma for buprenorphine use for individuals with End Stage Kidney Disease (ESKD) and Chronic Pain
Creating a multi-level intervention to reduce stigma for buprenorphine use for individuals with End Stage Kidney Disease (ESKD) and Chronic Pain
批准号:
10175416
负责人:
Manisha Jhamb
金额:
$25.09万
依托单位国家:
美国
项目类别:
财政年份:
2019
资助国家:
美国
项目状态:
已结题
起止时间:
2019-09-24 至 2024-05-31
关键词:
AddressAdvanced Malignant NeoplasmAdverse effectsAgeAgonistAnalgesicsAnti-Inflammatory AgentsAreaAwardBuprenorphineCessation of lifeChronicConfusionConstipationDataData AnalysesDevelopmentDiabetes MellitusDialysis procedureDoseDrug KineticsEnd stage renal failureEnrollmentFDA approvedFamilyFamily memberFundingGastrointestinal HemorrhageGeographyGroup ProcessesHealthHemodialysisHigh PrevalenceHospitalizationHypertensionIndividualInsuranceInsurance CarriersInterventionInterviewKidney FailureLicensingLiverMeasuresMental disordersMetabolismMethadoneMethodologyMethodsNational Institute of Diabetes and Digestive and Kidney DiseasesNursesObesityOpioidOpioid agonistPainPain managementParentsParticipantPatientsPharmaceutical PreparationsPharmacistsPharmacologyPhysical DependencePhysiologicalPrevalencePrimary Care PhysicianPrimary Health CareRaceRandomizedRandomized Controlled TrialsRegulationRenal functionResearchResearch PersonnelResearch SubjectsResidual stateRiskSafetySedation procedureSiteStructureSubstance Use DisorderSurveysTestingTimeTimeLineVentilatory Depressionaddictionbehavioral health interventionbile ductchronic paincomparativecostdesigndisabilityexperiencefallshigh riskimprovedmorphine equivalentmulti-site trialopioid therapyopioid use disorderorganizational structureparent grantpatient populationprescription opioidside effectsocial stigmatherapy developmenttreatment armwaiver
中文摘要
项目总结/摘要
患有终末期肾病(ESKD)的个体具有高患病率的疼痛状况。共同
由于ESKD本身或透析,止痛药的疗效和安全性较差
治疗丁丙诺啡,一种部分阿片激动剂,作为一种止痛药具有理论优势,
它的代谢是在肝脏中进行的,并且它不被透析。虽然它被批准用于疼痛治疗,
绝大多数被用于治疗阿片类药物使用障碍。对阿片类药物的偏见,尤其是
物质使用障碍的药物可能导致其很少用于疼痛。提供
从完全激动剂阿片类药物转换为丁丙诺啡是治疗中的积极干预手段之一,
NIDDK资助的ESKD和慢性疼痛患者的随机对照试验,
血液透析阿片类药物处方努力(HOPE)。这一拟议的补充将加强主要研究
通过审查多层次的障碍,重点是与开始和使用丁丙诺啡有关的耻辱感,
ESKD患者因处方长期阿片类药物治疗引起的疼痛和身体依赖性
透析该研究的目标1将为制定多层次的污名干预措施提供信息,
丁丙诺啡止痛药,当有指征时,在ESKD透析患者中,通过
利益相关者访谈患者、肾病学家、透析护士、初级保健医生,
丁丙诺啡处方者、透析组织和保险公司高管。我们会进行
对30名HOPE试验受试者及其家庭成员进行定性访谈(15名接受了
丁丙诺啡和15人没有),以及30名利益相关者,包括透析和初级保健临床医生,
丁丙诺啡处方者、药剂师、透析组织代表和保险公司
高管包括2名患者合作伙伴的研究团队将使用常数分析数据
比较方法为针对个人、组织和结构层面的干预提供信息。
该提案的目标2将采用用户设计冲刺方法来创建一个多功能的蓝图,
一级污名干预,将解决病人(内化污名),临床医生(人际
污名)、透析组织(组织)和保险公司(结构),以解决疼痛障碍
丁丙诺啡治疗ESKD患者,慢性疼痛,
阿片类药物该试验的一个探索性目的将包括一个有效的衡量患者耻辱的方法
参加母公司HOPE试验的患者将在补充剂的时间之后完成。在研究
完成后,研究小组将寻求资金,以测试和传播由此产生的建议,
干预
英文摘要
Project Summary / Abstract
Individuals with end stage kidney disease (ESKD) have high prevalence of painful conditions. Common
pain medications have poor efficacy and safety profiles due to either the ESKD itself or dialysis
treatment. Buprenorphine, a partial opioid agonist has theoretical advantages as a pain medication as
its metabolism is in the liver and it is not dialyzed. Although it is approved for pain treatment, it is
overwhelmingly prescribed as a treatment for opioid use disorder. Stigma toward opioids and especially
medications for substance use disorder may contribute to its being rarely prescribed for pain. Offering
to switch from full agonist opioids to buprenorphine is one of the active intervention arms in a HEAL-
funded NIDDK-sponsored randomized controlled trial in patients with ESKD and chronic pain,
Hemodialysis Opioid Prescription Effort (HOPE). This proposed supplement will augment the main study
by examining multilevel barriers, focusing on stigma related to initiation and use of buprenorphine for
pain and physical dependence due to prescribed long-term opioid therapy in individuals with ESKD on
dialysis. Aim 1 of the study will inform development of a multi-level stigma intervention to facilitate use
of buprenorphine pain medication, when indicated, in patients with ESKD on dialysis through
stakeholder interviews with patients, nephrologists, dialysis nurses, primary care physicians,
buprenorphine prescribers, dialysis organizations and insurance company executives. We will conduct
qualitative interviews with 30 HOPE Trial subjects and their family members (15 who accepted
buprenorphine and 15 who did not), and 30 stakeholders including dialysis and primary care clinicians,
buprenorphine prescribers, pharmacists, dialysis organization representatives and insurance company
executives. A study team including 2 patient-partners will analyze the data using the constant
comparative method to inform an intervention targeted at personal, organizational and structural levels.
Aim 2 of the proposal will employ a user design sprint methodology to create a blueprint for a multi-
level stigma intervention that would address patients (internalized stigma), clinicians (interpersonal
stigma), dialysis organizations (organizational) and insurers (structural) to address barriers to pain
treatment with buprenorphine in individuals with ESKD, chronic pain who are physiologically depending
on opioids. An exploratory aim of the trial will include a validated measure of stigma for patients
enrolled in the parent HOPE trial to be completed beyond the time of the supplement. At study
completion, the research team will seek funding to test and disseminate the resulting proposed
intervention.
期刊论文(4)
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DOI:
10.1016/j.semnephrol.2021.02.007
发表时间:
2021-01
期刊:
SEMINARS IN NEPHROLOGY
影响因子:
3.3
作者:
[Brintz, Carrie E., Cheatle, Martin D., Dember, Laura M., Heapy, Alicia A., Jhamb, Manisha, Shallcross, Amanda J., Steel, Jennifer L., Kimmel, Paul L., Cukor, Daniel]
通讯作者:
Cukor, Daniel
DOI:
10.1038/s41581-021-00484-6
发表时间:
2022-03
期刊:
Nature reviews. Nephrology
影响因子:
--
作者:
[Tobin DG, Lockwood MB, Kimmel PL, Dember LM, Eneanya ND, Jhamb M, Nolin TD, Becker WC, Fischer MJ, HOPE Consortium]
通讯作者:
HOPE Consortium
Stakeholder-Driven Intervention Development for Dialysis Trials Using a Design Sprint Methodology.
利益相关者驱动的干预开发使用设计Sprint方法进行透析试验。
DOI:
10.1016/j.xkme.2023.100729
发表时间:
2023-12
期刊:
KIDNEY MEDICINE
影响因子:
3.9
作者:
[Michalowski, Allison, Cavanaugh, Kerri L., Hamm, Megan, Wilkie, Caroline, Olejniczak, Donna M., Eneanya, Nwamaka D., Colditz, Jason, Jhamb, Manisha, Bulls, Hailey W., Liebschutz, Jane M.]
通讯作者:
Liebschutz, Jane M.
The design and baseline characteristics for the HOPE Consortium Trial to reduce pain and opioid use in hemodialysis.
HOPE 联盟试验的设计和基线特征,旨在减少血液透析中的疼痛和阿片类药物的使用。
DOI:
10.1016/j.cct.2023.107409
发表时间:
2024
期刊:
Contemporary clinical trials
影响因子:
2.2
作者:
[Dember,LauraM, Hsu,JesseY, Bernardo,Leah, Cavanaugh,KerriL, Charytan,DavidM, Crowley,SusanT, Cukor,Daniel, Doorenbos,ArdithZ, Edwards,DavidA, Esserman,Denise, Fischer,MichaelJ, Jhamb,Manisha, Joffe,Steven, Johansen,KirstenL, Kalim,]
通讯作者:
Kalim,
Pain Reduction and Opioid MedIcation Safety in ESRD (PROMISE) study
-
批准号:9901704
-
项目类别:
-
资助金额:$284.75万
-
财政年份:2019
-
负责人:Manisha Jhamb
-
依托单位:
Technology Assisted stepped Collaborative Care Intervention to Improve Patient-centered Outcomes in Hemodialysis
-
批准号:10331180
-
项目类别:
-
资助金额:$9.5万
-
财政年份:2017
-
负责人:Manisha Jhamb
-
依托单位:
Technology Assisted Stepped collaborative Care Intervention (TASCCI) to Improve Patient-centered Outcomes in Hemodialysis Patients
-
批准号:10203935
-
项目类别:
-
资助金额:$61.72万
-
财政年份:2017
-
负责人:Manisha Jhamb
-
依托单位:
Technology Assisted Stepped collaborative Care Intervention (TASCCI) to Improve Patient-centered Outcomes in Hemodialysis Patients
-
批准号:9363863
-
项目类别:
-
资助金额:$67.13万
-
财政年份:2017
-
负责人:Manisha Jhamb
-
依托单位: