Computerized PAINRelieveIt for Adult Sickle Cell Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 279
- 试验地点
- 1
- 主要终点
- Misperception About Pain (BQ-13)
研究概览
简要总结
Sickle cell disease (SCD) is a blood disorder that is characterized by intense, painful episodes known as sickle cell crises. This study will evaluate the effectiveness of PAINRelieveIt, a three-part computer-based pain management tool, in treating adults with SCD.
详细描述
SCD is an inherited blood disorder that mainly affects people of African, Mediterranean, or Latin descent. Symptoms include anemia, infections, organ damage, and painful sickle cell crises. Adults with SCD who experience frequent painful crises are more likely to die sooner than are adults with SCD who have fewer painful crises. Experts suggest that SCD pain be treated in the same way that cancer pain is treated because both types of pain are sustained and severe. However, unlike the research directed towards cancer pain, research focused on the characteristics of SCD pain has been limited. Although medications are available to treat SCD pain, the SCD pain management process is complex and often requires more time than what is available during the typical medical appointment. Recent advances in computer technologies may provide an opportunity to improve the effectiveness of SCD pain management by combining online patient education with decision-making support tools for doctors. This study will evaluate three touch screen computerized tools that are known collectively as PAINRelieveIt. The three tools include the following:
- PAINReportIt-a pain assessment data collection tool
- PAINUCope-a multimedia patient education program tailored to the participant's SCD pain management misconceptions
- PAINConsultN-a decision support tool for doctors that will provide algorithm-based pain medication therapies tailored to each participant's pain level
This two-part study will evaluate the effectiveness of PAINReportIt and PAINUCope, alone and in combination with PAINConsultN, at improving participants' SCD pain by educating participants about their role in pain management and by providing decision-making support to doctors.
This study will enroll patients who are receiving care at the University of Illinois at Chicago Sickle Cell Clinic. The patients will be randomly assigned to either the experimental group or the control group. It comprises two phases. In Phase 1, the patients in the experimental group will have access to PAINReportIt and PAINUCope, which the control will have access to PAINReportIt and a selection of games. At baseline and Month 3, participants will complete questionnaires on misconceptions about pain, medication adherence, and pain intensity. The same participants from Phase 1 of the study will be enrolled into Phase 2 of the study with the same group assignment, which will last 2 years. In Phase 2, the experimental group participants will be assigned to receive care from doctors who have access to PAINConsultN while the control group will be assigned to usual care. All participants will have access to PAINReportIt and PAINUCope in Phase 2. At baseline and Year 2, participants will complete questionnaires on pain episodes. Information will also be collected from doctors, including pain documentation, appropriateness of prescribed pain medications, and the number of emergency department visits by and hospitalizations of participants experiencing painful SCD crises.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Supportive Care
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with SCD
- •Scheduled for continuing care at the University of Illinois at Chicago Sickle Cell Clinic
- •Experienced a moderate to severe level of pain (at least 3 on 0 to 10 scale) related to the SCD within the 12 months prior to study entry
- •Had a emergency department visit or hospitalization within the 2 years prior to study entry
- •Speaks and reads English
排除标准
- •Legally blind
- •Physically unable to complete study questionnaire
研究组 & 干预措施
Control
In Phase 1 of the study, participants will access PAINReportIt and computer games. PAINReportIt helps the patient describe the pain experienced. In Phase 2 of the study, participants will continue to access PAINReportIt when they are seen in the clinic, emergency department (ED), acute care center (ACCA), and hospital. They will gain access to the PAINUCope computer-based programs, which provides multimedia education tailored to the patient's misconceptions about pain management. They will receive medial usual care at the outpatient clinic, ED, ACC, and hospital.
干预措施: PAINReportIt (Phase 1 + 2) (Behavioral)
Control
In Phase 1 of the study, participants will access PAINReportIt and computer games. PAINReportIt helps the patient describe the pain experienced. In Phase 2 of the study, participants will continue to access PAINReportIt when they are seen in the clinic, emergency department (ED), acute care center (ACCA), and hospital. They will gain access to the PAINUCope computer-based programs, which provides multimedia education tailored to the patient's misconceptions about pain management. They will receive medial usual care at the outpatient clinic, ED, ACC, and hospital.
干预措施: PAINUCope (Phase 2) (Behavioral)
Experimental
In Phase 1 of the study, participants will access PAINReportIt and PAINUCope computer-based programs. PAINReportIt helps the patients describe the pain experiences and PAINUCope provides multimedia education tailored to the patient's misconceptions about pain management. In Phase 2 of the study, participants will continue to access PAINReportIt and PAINUCope programs when they are seen in the clinic, emergency department (ED), acute care center (ACC), and hospital. Their doctors will have access to PAINConsultN when seen at the ED, ACC, and hospital. PAINConsultN is just-in-time decision support for the physicians with the pain data summarized and suggestions for analgesics that may be useful to help manage the patient's pain.
干预措施: PAINReportIt (Phase 1 + 2) (Behavioral)
Experimental
In Phase 1 of the study, participants will access PAINReportIt and PAINUCope computer-based programs. PAINReportIt helps the patients describe the pain experiences and PAINUCope provides multimedia education tailored to the patient's misconceptions about pain management. In Phase 2 of the study, participants will continue to access PAINReportIt and PAINUCope programs when they are seen in the clinic, emergency department (ED), acute care center (ACC), and hospital. Their doctors will have access to PAINConsultN when seen at the ED, ACC, and hospital. PAINConsultN is just-in-time decision support for the physicians with the pain data summarized and suggestions for analgesics that may be useful to help manage the patient's pain.
干预措施: PAINUCope (Phase 1) (Behavioral)
Experimental
In Phase 1 of the study, participants will access PAINReportIt and PAINUCope computer-based programs. PAINReportIt helps the patients describe the pain experiences and PAINUCope provides multimedia education tailored to the patient's misconceptions about pain management. In Phase 2 of the study, participants will continue to access PAINReportIt and PAINUCope programs when they are seen in the clinic, emergency department (ED), acute care center (ACC), and hospital. Their doctors will have access to PAINConsultN when seen at the ED, ACC, and hospital. PAINConsultN is just-in-time decision support for the physicians with the pain data summarized and suggestions for analgesics that may be useful to help manage the patient's pain.
干预措施: PAINConsultN (Phase 2) (Behavioral)
Experimental
In Phase 1 of the study, participants will access PAINReportIt and PAINUCope computer-based programs. PAINReportIt helps the patients describe the pain experiences and PAINUCope provides multimedia education tailored to the patient's misconceptions about pain management. In Phase 2 of the study, participants will continue to access PAINReportIt and PAINUCope programs when they are seen in the clinic, emergency department (ED), acute care center (ACC), and hospital. Their doctors will have access to PAINConsultN when seen at the ED, ACC, and hospital. PAINConsultN is just-in-time decision support for the physicians with the pain data summarized and suggestions for analgesics that may be useful to help manage the patient's pain.
干预措施: PAINUCope (Phase 2) (Behavioral)
结局指标
主要结局
Misperception About Pain (BQ-13)
时间窗: Measured at Month 3
Range 0-5. Higher score indicates more perceived barriers (greater concern about pain management beliefs and/or analgesic side effects)
Composite Pain Index (CPI)
时间窗: Measured at Month 3
Range 0-100. Higher score indicates worse pain.
Analgesic Adherence
时间窗: Measured at Month 3
Range 0-1. Higher is better.
Time in Pain Crisis
时间窗: Measured over the course of Phase 2, a 2-year period.
Percentage of days in pain crisis during Phase 2. Range 0-100. Lower is better.
Pain Documentation
时间窗: Measured over the course of Phase 2, a two-year period.
Completeness of pain documentation during Phase 2. Range 0-100. Higher is better.
Appropriateness of Analgesic Prescription
时间窗: Average over the course of Phase 2, a two-year period.
Percentage of appropriate analgesic prescriptions during Phase 2. Range 0-100. Higher is better.
次要结局
未报告次要终点
研究者
Diana J. Wilkie
Professor
University of Illinois at Chicago