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Optimizing Patient Engagement in a Novel Pain Management Initiative (OPEN) (OPENtext)

2018年4月16日 更新者:Traci Green、Inflexxion, Inc.
The OPEN study has two aims: The first is to identify what helps to keep patients involved with a Medicaid chronic pain management program and to identify features of an ideal text-message-based program for people enrolled in the program. The second aim is to develop the text-message-based program (OPENtext), then find out how useful this intervention is compared to a patient navigator intervention (OPENnav) for increasing patient engagement, improving patient's motivation to manage their chronic pain, and improving patient confidence in self-managing their chronic pain condition.

研究概览

地位

完全的

条件

详细说明

Chronic pain is a condition that affects the most fundamental aspects of quality of life. Treatment for chronic pain is challenging and usually takes the form of opioid medication therapy. But chronic opioid therapy is also associated with high rates of emergency department use, drug diversion, addiction, and unintentional overdose deaths. The new RI Medicaid Chronic Pain Initiative (CPI) targets patients who are both high emergency department users and experiencing chronic pain. In the CPI, patients can be prescribed an integrated treatment plan of massage, chiropractic, or acupuncture therapies. This is a novel approach to chronic pain care, but retention and patient engagement are low. It is important to understand why involvement in the CPI is low, how to improve the patient experience, and how to support the prescribed CAM therapies.

This study has two aims: The first is to identify what helps to keep patients involved with the CPI program and to identify features of an ideal text-message-based program for people enrolled in the CPI. The second aim is to develop the text-message-based program (OPENtext), then find out how useful this intervention is compared to a patient navigator intervention (OPENnav) for increasing patient engagement, improving patient's motivation to manage their chronic pain, and improving patient confidence in self-managing their chronic pain condition.

Investigators will conduct qualitative interviews with patients, providers, and administrators. Goals of the interviews will be: to understand the patient experience in the CPI, including experiences with the navigation approach currently in place; to identify barriers and facilitators to CPI participation; and to learn how technology-especially cell phone text-messaging-could help support pain care and CPI engagement. These interviews will help develop a text-message-based intervention and provide feedback to existing patient navigator programming. Next, investigators will develop and test the text-message patient support intervention that will contain patient-identified topics and concerns that emerge from the qualitative interviews and topic areas discussed by a stakeholder Advisory Board. Theories of behavior change will be used to help with message development, and patients will take part in helping to test and fine-tune the intervention. Last, investigators will compare the text-message and patient navigation interventions in a randomized controlled study with 200 patients over a six-month period. Investigators will see which approach helps patients increase their involvement in the CPI and better manage their chronic pain. If successful, chronic pain patients across Medicaid programs could benefit from use of the patient navigation or the text-message intervention.

研究类型

介入性

注册 (实际的)

197

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Rhode Island
      • Providence、Rhode Island、美国、02903
        • Rhode Island Hospital

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

19年 至 65年 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Enrolled in the Rhode Island Medicaid Chronic Pain Initiative program

Exclusion Criteria:

  • Do not speak English

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:卫生服务研究
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
实验性的:OPENtext
OPENtext will target cognitive, affective, and behavioral strategies through a single, brief in-person assessment, followed by 12 weeks of theoretically-informed text messages, a core set of information organized in a 'frequently asked questions' structure, interactive peer support, static resources on key patient-identified topics, and a library of peer stories accessible throughout the study period.
Participants will receive 12 weeks of daily text messages sent from an automated system. The text messages will assist participants in managing their chronic pain.
有源比较器:OPENnav
Peer Navigation is currently offered to some individuals in this Medicaid population but not all. Peer navigators interact with patients by phone/text and at home visits. Efforts focus on drivers of a patient's ED use, and may include providing or identifying patient support, improving health literacy, assisting with transportation vouchers, health education, family support, accessing housing services, and orienting to other community support services.
Particpants will be linked with a RIPN PEER Navigator who will assisted them in managing their health care

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Change in Engagement
大体时间:Once per month for 6 months
Investigators will capture change in engagement in the CPI program based on utilization of services per month, derived from AMI's administrative records. For the purposes of this study, engagement will be defined as having one or more visits to a CAM provider in a given month.
Once per month for 6 months
Readiness to Change
大体时间:At baseline, 3 months, and 6 months post-randomization
The Pain Stages of Change Questionnaire (PSOCQ) will be used to measure change in patient's self-reported engagement in the CPI and in the intervention group.
At baseline, 3 months, and 6 months post-randomization
Change in Self-Efficacy
大体时间:At baseline, 3 months, and 6 months post-randomization
To measure patient's change in confidence of their ability to self-manage their condition, investigators will use the Chronic Pain Self Efficacy Scale (CPSS).
At baseline, 3 months, and 6 months post-randomization

次要结果测量

结果测量
措施说明
大体时间
Pain Severity
大体时间:At baseline, 3 months, and 6 months post-randomization
To assess the severity of pain and the impact of pain on daily functions, investigators will use the Brief Pain Inventory short form (BPI), which is commonly used in clinical trials and has documented validity, reliability, and responsiveness to change.
At baseline, 3 months, and 6 months post-randomization
Quality of Life
大体时间:At baseline, 3 months, and 6 months post-randomization
Investigators will use the Short Form-12 (SF-12)103, a global measure of patient quality of life with well-established psychometrically sound properties across many disease areas and populations, including chronic pain patients. The SF-12 is responsive to interventions, and is currently being used as the key CPI patient evaluation measure by AMI.
At baseline, 3 months, and 6 months post-randomization
Pain Medication Use
大体时间:At baseline, 3 months, and 6 months post-randomization
Schedule II/III opioid medication utilization will derive from the RI Department of Health (HEALTH)'s Prescription Monitoring Program (PMP) database.
At baseline, 3 months, and 6 months post-randomization
Likelihood of Misusing Opioid Medication
大体时间:At baseline, 3 months, and 6 months post-randomization
The SOAPP-R and COMM are quick and easy-to-use, designed to help providers evaluate the patients' relative risk for developing problems when placed on long-term opioid therapy (SOAPP-R) or to monitor chronic pain patients on opioid therapy (COMM). As a screening tool, the SOAPP-R and the COMM are recommended by SAMHSA in the treatment of chronic pain in patients with histories of or at risk of substance use disorder.
At baseline, 3 months, and 6 months post-randomization
Safety and Aberrant Pain Medication Use Behaviors
大体时间:At baseline, 3 months, and 6 month post-randomization
Investigators will examine patient ED utilization from the health plans' (UH,NH) claims data and prevalence and incidence of aberrant opioid medication use (i.e.,"dr. shopping") from the RI PMP database.
At baseline, 3 months, and 6 month post-randomization
Acceptance & Satisfaction
大体时间:At 9-month follow up
Patients will be asked to rate intervention utility and content (relevance, interest) using 5-point Likert scales.
At 9-month follow up

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Traci Green, PhD, MSc、Inflexxion, Inc., Brown University, and Rhode Island Hospital
  • 学习椅:Megan Ranney, MD、The Miriam Hospital and Brown University
  • 学习椅:Elizabeth Donovan, PhD、Independent consultant

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2015年9月1日

初级完成 (实际的)

2017年9月14日

研究完成 (实际的)

2018年1月31日

研究注册日期

首次提交

2014年5月7日

首先提交符合 QC 标准的

2014年5月8日

首次发布 (估计)

2014年5月12日

研究记录更新

最后更新发布 (实际的)

2018年4月18日

上次提交的符合 QC 标准的更新

2018年4月16日

最后验证

2018年4月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • IHS -1306-02960

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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