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改善关于疼痛和阿片类药物的沟通

2026年7月23日 更新者:University of California, Davis

改善初级保健中与疼痛相关的沟通、疼痛管理和阿片类药物处方的临床医生培训干预

该协议的总体目标是对临床医生培训干预进行试点测试,该干预使用标准化患者(经过培训的扮演患者角色的演员)作为向初级保健临床医生传授沟通技巧的讲师。 该项目将对主要研究者开发的干预措施进行试点临床试验,以评估干预措施的可行性并生成数据以计划随后的全面、多中心试验。 初级保健临床医生将随机接受干预或控制; 48 名患者(每位临床医生 2 名)随后将在研究临床医生的门诊访问期间被记录下来,并将提供有关访问后感知和健康结果的数据。 研究假设是,拜访接受干预的临床医生(相对于对照组)将与更频繁地使用有针对性的沟通技巧、更低的高风险阿片类药物处方可能性、更高的患者报告的治疗计划一致性以及更低的疼痛干扰相关联 2几个月后。

研究概览

详细说明

随机对照试验 (RCT) 中的唯一干预措施是临床医生教育。 该随机对照试验不会直接操纵或影响患者护理。 因此,这项研究的风险很小。 唯一可预见的患者风险与数据机密性和隐私有关。

研究人员将为随机对照试验招募大约 48 名初级保健临床医生。 研究目标是招募 24 名居民和 48 名患者(每位居民 2 次患者就诊)。 然而,根据以往在这些诊所采用类似招募方法的经验,只有大约 50% 的注册临床医生最终会拜访研究患者。 因此,有必要过度招募临床医生,因为研究人员预计,由于没有看到任何研究患者,很大一部分居民将不得不退出研究。 注册后,临床医生将完成一份简短的调查问卷,包括人口统计学和关于与患者就慢性疼痛和阿片类药物进行交流的自我效能感。

随机化分配将在所有临床医生提供知情同意并登记后进行,以防止随机化状态影响登记决定。 招募所有临床医生后,研究人员将进行随机分配。 随机化是在临床医生层面进行的。 由于干预的性质,不可能对受试者或研究者进行盲法分配。 然而,患者将不知道临床医生的随机化分配。

干预临床医生将在常规门诊时间内完成 2 次标准化患者就诊。 第一次访问将包括观看 8-10 分钟的总结关键沟通技巧的视频、10-12 分钟的角色扮演练习来练习使用这些技能,以及 8-10 分钟的建设性反馈。 第二个视频将只有滚动播放和反馈。 对照临床医生将收到 2016 年疾病控制和预防中心 (CDC) 阿片类药物处方指南的书面摘要,其中包括使用阿片类药物治疗慢性非癌症疼痛的最佳实践建议。 在可能的范围内,调查人员将使用 CDC 生产的材料作为对照组。 CDC 指南将作为注意力控制。 干预临床医生将完成一份评估干预的简短问卷。 一段时间后,登记的临床医生将看到 2 名患者,他们已经过研究团队的筛选和登记,并且同意允许对先前安排的与 pcp 的访问进行录音。 数据将包括录音笔录、就诊前和就诊后患者问卷以及临床医生就诊后问卷。

每位患者就诊后 2 个月,研究助理将致电患者并获得 2 个月的随访数据(例如 简要疼痛清单)。

研究类型

介入性

注册 (实际的)

95

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

    • California
      • Sacramento、California、美国、95817
        • University of California Davis Family Medicine Clinic
      • Sacramento、California、美国、95817
        • University of California Davis Internal Medicine Clinic

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

18年 及以上 (成人、年长者)

接受健康志愿者

不

描述

纳入标准:

加州大学戴维斯分校的内科或家庭医学住院医师:

  • 完成≥1年的培训
  • 在门诊护理中心 (ACC) 大楼看初级护理患者。 临床医生将通过诊所会议、电子邮件和会议演示来招募。

加州大学戴维斯分校患者:

  • 18-80岁
  • 服用初级保健医生开具的阿片类药物(每天≥1 剂阿片类药物)>90 天以治疗慢性肌肉骨骼疼痛
  • 与参与的临床医生安排了约会,他们报告说他们可能会讨论疼痛管理

排除标准:

  • 活动性癌症
  • 收容所
  • 不会说英语
  • 犯人
  • 孕妇
  • 无法同意

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:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Clinicians - Communication skills training
Intervention clinicians will receive 2 standardized patient visits. The first visit will consist of an 8 minute video on the development of 5 key communication skills, a 10-12 minute role-play session to practice using these skills, and 8-10 minutes of constructive feedback. The 2nd visit will include only the role-play and feedback components. Clinicians will also get a printed pocket card and pamphlet explaining the targeted communication skills in more detail.
Intervention components include an 8-10 minute instructional video, a pocket card and pamphlet, and 2 standardized patient visits with role-play and feedback by the standardized patient
有源比较器:Clinician Control
Control clinicians will receive a written summary of the 2016 CDC opioid prescribing guidelines, which include recommendations for best practices for use of opioids to treat chronic non-cancer pain. CDC guidelines will serve as an attention control.
Physician will review materials based on CDC opioid prescribing guidelines.
实验性的:Patient seeing trained clinician
Patients taking opioids for chronic pain who are established clinic patients and have an appointment with a clinician who has received the communication training will be recruited for this arm.
patient with a scheduled visit with a clinician who received the communication training.
有源比较器:Patient seeing control clinician
Patients taking opioids for chronic pain who are established clinic patients and have an appointment with a clinician who has NOT received the communication training (Clinician control group) will be recruited for this arm.
patient with a scheduled visit with a clinician who did not receive the communication training.

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
Clinician Number of Targeted Behaviors Per Visit
大体时间:Over a 3-9 month period (depending on how soon after the intervention clinicians' appointments with patient participants can be scheduled).
Compare frequency of use of targeted communication behaviors observed per visit for residents in the Intervention vs Control arm (using coding of recorded visits to assess skill use). We first developed a list of targeted communication behaviors that were targeted by our intervention and based on our conceptual model. We developed a coding manual to count the number of unique behaviors in each study visit. We analyzed audio recordings and transcripts from all study visits to count the number of targeted behaviors per each visit. Multiple team members measured communication behaviors in each visit to ensure reliability of this measure.
Over a 3-9 month period (depending on how soon after the intervention clinicians' appointments with patient participants can be scheduled).
Compare Efficacy of Control vs Intervention by Measuring Changes in the Way Pain Interfered With Patients Lives Using the Brief Pain Inventory - Pain Interference Subscale Survey
大体时间:8 weeks
Brief Pain Inventory (BPI) Pain Interference subscale consists of 7 categories relating to how pain interferes with patients' lives. Patients are asked to rate their pain on a zero (Does Not Interfere) to 10 (Completely Interferes) scale. The 7 categories are: 1. General Activity, 2. Mood, 3. Walking Ability, 4. Work, 5. Relationships, 6. Sleep, 7. Enjoyment of life. Results are averaged to give an overall interference rating from 0-10, with higher scores indicating worse pain.
8 weeks

次要结果测量

结果测量
措施说明
大体时间
Compare Efficacy of Control vs Intervention by Measuring Changes in the Severity of Patients Pain Using the Brief Pain Inventory - (Short Form) Pain Severity Subscale Which Measures the Severity of the Patient's Pain.
大体时间:8 weeks
Brief Pain Inventory (BPI) Short Form -- Pain Severity subscale has 4 survey questions / categories, asking patients to rate the severity of their pain on a 0-10 scale (with 0 being No Pain and 10 being Worst Possible Pain). The 4 Categories are, A. At it's worst in the last 24 hours, B. At it's best in the last 24 hours, C. Pain on average, D. Pain right now. Results are averaged to give an overall score (0-10) with higher scores indicating worse outcomes.
8 weeks
Difficult Doctor-Patient Relationship Questionnaire
大体时间:Over a 3-9 month period (depending on how soon after the intervention clinicians' appointments with patient participants can be scheduled).
Comparison of difficult doctor-patient encounter scale for Intervention vs Control physicians. Difficult doctor-patient relationship scale has 10 items scored from 1-6. The overall scale range is 10-60, with higher values indicating more difficult (worse) visits. Physicians complete this measure for each study patient.
Over a 3-9 month period (depending on how soon after the intervention clinicians' appointments with patient participants can be scheduled).
Patient Experience Score
大体时间:8 weeks

Patient experience score for patients who saw Intervention and Control physicians, measured by post visit patient agreement with treatment plan, patient trust, and patient assessment of clinician communication skills. Patient experience is a standardized composite average of three validated scales:

Consumer Assessment of Healthcare Providers and Systems (CAHPS) Adult Visit Survey communication subscale, range 0 to 12, with higher scores indicating better communication.

Patient Agreement with Treatment Plan Scale, range 3 to 21, with higher scores indicating greater agreement.

Brief Wake Forest Physician Trust Scale, range 5 to 25, with higher scores indicating greater trust.

The three scales were standardized and averaged into a single composite score. The theoretical composite score ranges from -4.5 to 0.6, with higher scores indicating a better patient experience. Results are reported separately for each study arm as mean (standard deviation).

8 weeks
Physicians' Overall Appraisal of the Standardized Patient Intervention
大体时间:1-3 months
Physician reported assessment of intervention. Investigators will ask for physicians' evaluation of the feasibility, acceptability, and utility of the intervention. Investigators will offer 10 value statements about the intervention. Physicians will select 1 from the following choices: strongly agree, agree, neutral, disagree, strongly disagree. Results will be reported as the percentage who agree or strongly agree with each statement.
1-3 months
Physician Communication Self-efficacy
大体时间:Over 3-9 month period (depending on how soon after the intervention clinicians' appointments with patient participants can be scheduled).
Physician self-efficacy for communication skills for Intervention vs Control physicians. These questions ask about physicians' confidence related to managing chronic non-cancer pain in primary care. Physicians will be asked to rate how strongly they agree or disagree with 8 statements (each on 1-5 scale. Higher values indicate greater (better) self-efficacy. Baseline and post-visit ratings of self efficacy will be computed, and we will measure change in self efficacy (post-visit self efficacy minus baseline self efficacy) for Control vs Intervention physicians. Overall score range will be 1-5, with higher numbers indicating better self efficacy.
Over 3-9 month period (depending on how soon after the intervention clinicians' appointments with patient participants can be scheduled).

其他结果措施

结果测量
措施说明
大体时间
High-risk Opioid Prescribing
大体时间:Over 3-9 month period (depending on how soon after the intervention clinicians' appointments with patient participants can be scheduled).
Prevalence of high-risk opioid prescribing as measured by chart review; defined either as being prescribed 90MME or more OR being prescribed opioids plus benzodiazepines 2 months after study completion based on chart review
Over 3-9 month period (depending on how soon after the intervention clinicians' appointments with patient participants can be scheduled).

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:Stephen G Henry, MD、University of California, Davis

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)

2018年8月15日

初级完成 (实际的)

2019年11月5日

研究完成 (实际的)

2019年12月31日

研究注册日期

首次提交

2018年7月31日

首先提交符合 QC 标准的

2018年8月9日

首次发布 (实际的)

2018年8月14日

研究记录更新

最后更新发布 (实际的)

2026年7月27日

上次提交的符合 QC 标准的更新

2026年7月23日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

其他研究编号

  • 970014
  • 5K23DA043052 (美国 NIH 拨款/合同)
  • A18-0560 (其他标识符:UC Davis)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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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