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临床试验/NCT03304145
NCT03304145已完成不适用

Shared Decision Making in Pain Management Planning in Patients With Cancer

Carevive Systems, Inc.2 个研究点 分布在 1 个国家目标入组 105 人开始时间: 2017年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
105
试验地点
2
主要终点
Effect of pain care plan on pain outcomes

研究概览

简要总结

The goal of this project is to evaluate the effectiveness of shared-decision-making (SDM) to manage chronic and breakthrough pain in patients with cancer. Providers will receive evidence-based education on shared decision-making strategies and comprehensive pain management at study start up. In addition, the information will be available on the Carevive platform for reference at the point of care. This multisite study will enroll 105 patients from three cancer institutions. This project will explore the SDM model using a touchscreen-based expanded pain assessment (EPA) to evaluate the impact of the shared-decision-making model on pain management, and explore its relationship to pain management care planning. Patients will use the Carevive Systems software in the clinic to answer questions regarding decision making preferences and complete a comprehensive assessment of their pain status. Treatment recommendations and a care plan will be provided to the patient at the time of the visit. At each clinic visit over 4 months, the patient will again complete the pain assessment and receive appropriate treatment recommendations and a revised care plan.

详细描述

Cancer-related pain is a significant clinical challenge that impacts patient outcomes and remains a significant problem for patients with cancer and their providers. The overall prevalence of cancer pain is high; a recent meta-analysis of 52 studies reported cancer pain prevalence ranging between 52%-77%. Another update reports rates of 39% after curative treatment, 55% during treatment, and 66% in advanced, metastatic or terminal disease. Moderate to severe pain was reported by 38% of all patients. Cancer pain may be cancer related, due to tumor burden causing bone, nerve, and/or organ compression, and/or treatment related, due to procedures, surgery, and side effects of chemotherapy or radiation. The prevalence of pain after breast cancer treatment ranges from 13%-93%; women with metastatic breast cancer often have bone pain from metastases and bisphosphonates. In a nationwide lung cancer study (N = 450), pain was reported by 92% of patients with advanced (stage IIIB/IV) NSCLC. Similar reports indicate pain ranges from 74% to 92%. Uncontrolled pain is the most common chief complaint of unplanned hospitalizations and readmissions. One study reported over half of the chief complaints provided by breast cancer patients with an emergency department (ED) visit were related to poorly controlled pain, respiratory or gastrointestinal symptoms. Finally, there is evidence that high symptom burden and poor management of symptoms and side effects also leads to suboptimal adherence to therapy.

Management of cancer pain requires that the patient be screened for the presence of pain at every clinical contact. A comprehensive assessment should be conducted if the patient is experiencing pain, including specific questions about location, duration, severity, quality, timing, duration, and impact on quality of life. A thorough understanding of pain also considers the temporal characteristics of the pain experience, determining if the pain is intermittent, that is bursts of severe pain without persistent chronic pain, persistent, with moderate to severe pain present throughout the day, and/or breakthrough pain described as the transient exacerbation of pain despite adequately controlled persistent pain. Breakthrough pain is reported to occur daily in 21%-70% of patients.

The prevalence of psychosocial and physical symptom distress in cancer is so compelling that the Commission on Cancer, the Oncology Nursing Society (ONS), American Society of Clinical Oncology (ASCO), and the National Committee for Quality Assurance (NCQA)'s Patient-Centered Oncology Care Standards all require distress screening that includes pain screening and assessment as a quality mandate in their accreditation and quality certification programs. In addition, the Centers for Medicare and Medicaid Services (CMMS)'s Oncology Care Model (OCM) requires a care management plan that includes symptom management. Included as quality measures are NQF384, pain intensity quantified, and NQF 383, plan of care for pain. In addition, value based care payment models seek to decrease emergency department (ED) visits and hospitalization days.

Carevive recently completed a project designed to improve adherence to quality metrics in breast cancer through education plus use of a tablet-based technology to screen for and manage identified distress, pain, and other breast cancer quality indicators available within ASCO's Quality Oncology Practice Initiative (QOPI) program. The Breast National Quality Standards project used QOPI metrics to evaluate outcomes of a CME intervention and use of the Carevive CPS. Preliminary data from this project showed improvement in key areas. Provider adherence to quality metrics was measured in 151 non-metastatic BC patients, 77 of which served as historical controls with no CME/clinical intervention, and 74 received the intervention after their provider participated in certified continuing medical education (CME) activities designed to educate about evidence-based assessment, decision-making, and management strategies for BC patients. Preliminary analysis showed that the intervention improved provider adherence to four pain quality measures: a. pain assessed by second office visit, b) pain intensity quantified by second office visit, c) plan of care documented, and d) pain assessed on either of the two most recent office visits. This project will build on that work to incorporate a comprehensive assessment and a more multi-faceted intervention that engages the care team in a SDM process around cancer pain management.

Along with an imperative to formalize a pain management plan is the rising importance of incorporating shared-decision-making, the cornerstone of patient centered care, into all care decisions. When making treatment decisions, the provider must incorporate current literature, patients' current clinical status, and patient preferences. One challenge with measuring quality through electronic chart abstraction is the difficulty of identifying when patient preference has influenced treatment decisions. Little data currently exist on the level of patient engagement in decision-making for pain management and the perception of patients with MBC, LC, or AC of shared-decision-making in developing a pain management care plan. Dr. Jeannine Brant and colleagues have developed the Pain Care Quality Survey (PainCQ©). The PainCQs are two tools that measure the quality of nursing and interdisciplinary care related to pain management as perceived by hospitalized individuals. These tools will be modified in this project to capture the variable contributions of different members in the care team, including oncology nursing staff.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All participants must be 18 years of age or older.
  • Patient participants must have a diagnosis of cancer
  • Patients must have screened positive for pain per a previous clinical assessment
  • All participants must be able to understand English.

排除标准

  • Any patient who cannot understand written or spoken English.
  • Any prisoner and/or other vulnerable persons as defined by NIH (45 CFR 46, Subpart B, C and D).

结局指标

主要结局

Effect of pain care plan on pain outcomes

时间窗: Year 1

Pain intensity over time will be measured by the Sum of Pain Intensity Differences (SPID).

次要结局

  • Feasibility of the proposed shared decision-making model to effectively manage chronic pain experienced by patients with cancer(Year 1)
  • Contribution of shared-decision-making on pain outcomes will be evaluated using the PainCQ© surveys(Year 1)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (2)

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