A Clinician Training Intervention to Improve Pain-related Communication, Pain Management and Opioid Prescribing in Primary Care
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 95
- 试验地点
- 4
- 主要终点
- Clinician use of targeted communication skills
研究概览
简要总结
The overall goal of this protocol is to pilot test a clinician training intervention that uses standardized patients (trained actors playing patient roles) as instructors who impart communication skills to primary care clinicians. This project will conduct a pilot clinical trial of the intervention developed by the primary investigator in order to evaluate intervention feasibility and generate data to plan a subsequent fully-powered, multisite trial. Primary care clinicians will be randomized to receive either the intervention or control; 48 patients (2 per clinician) will then be recorded during clinic visits with study clinicians and will provide data on post-visit perceptions and health outcomes. Study hypotheses are that visits with clinicians who receive the intervention (versus control) will be associated with more frequent use of targeted communication skills, lower probability of high-risk opioid prescribing, higher patient-reported agreement with treatment plan, and lower pain interference 2 months later.
详细描述
The only intervention in the randomized controlled trial (RCT) will be clinician education. This RCT will not directly manipulate or influence patient care. Therefore, this study is minimal risk. The only foreseeable patient risks relate to data confidentiality and privacy.
The investigators will recruit approximately 48 primary care clinicians for the pilot RCT. The study goal is to enroll 24 residents and 48 patients (2 patient visits per resident). However, based on previous experience with similar recruitment methods in these clinics, only about 50% of enrolled clinicians will ultimately have visits with study patients. Thus, it will be necessary to over-enroll clinicians because the investigators expect a large proportion of residents will have to be dropped from study due to not seeing any study patients. After enrollment, clinicians will complete a brief questionnaire including demographics and self efficacy regarding communicating with patients about chronic pain and opioids.
Randomization assignment will take place after all clinicians have provided informed consent and enrolled, to prevent randomization status from influencing enrollment decisions. Randomization assignment will be done by study personnel after all clinicians have been recruited. Randomization is at the clinician level. Because of the nature of the intervention, it is not possible to blind subjects or investigators to randomization assignment. However, patients will be unaware of clinicians' randomization assignment.
Intervention clinicians will complete 2 standardized patient visits during regular clinic time. The first visit will include viewing an 8-10 minute video summarizing the key communication skills, a 10-12 minute roll-play session to practice using these skills, and 8-10 minutes of constructive feedback. The second video will have only roll-play and feedback. Control clinicians will receive a written summary of the 2016 Centers for Disease Control and Prevention (CDC) opioid prescribing guidelines which include recommendations for best practices for use of opioids to treat chronic non-cancer pain. To the extent possible, the investigators will use CDC-produced materials for the control group. CDC guidelines will serve as an attention control. Intervention clinicians will complete a brief questionnaire evaluating the intervention. Some time later, enrolled clinicians will see 2 patients who've been screened and enrolled by the research team and who've agreed to allow a previously scheduled visit with pcp to be audio recorded. Data will include the audio recording transcripts, a pre-visit and post-visit patient questionnaire and a clinician post-visit questionnaire.
2 months after each patient's visit, a research assistant will call patients and obtain 2-month follow up data (e.g. Brief Pain Inventory).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
盲法说明
Physicians will be randomized after physician recruitment is complete. This ensures that arm assignment does not impact physicians' decision to participate. Arm assignment will be done using a random number generator. Due to the nature of the intervention, blinding participants (physicians) is not feasible. However, patients will not be aware of their physician's arm assignment.
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
- •Internal Medicine or Family Medicine residents at UC Davis:
- •completed ≥1 year of training
- •see primary care patients in the Ambulatory Care Center (ACC) building. Clinicians will be recruited through clinic huddles, emails, and presentations at meetings.
- •UC Davis Patients:
- •18-80 years old
- •taking opioids (≥1 opioid dose per day) prescribed by their primary care physician for >90 days to treat chronic musculoskeletal pain
- •have an appointment scheduled with a participating clinician at which they report they are likely to discuss pain management
排除标准
- •active cancer
- •do not speak English
- •prisoners
- •pregnant women
- •unable to consent
结局指标
主要结局
Clinician use of targeted communication skills
时间窗: 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 skills for residents in the Intervention vs Control arm (using coding of recorded visits to assess skill use)
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
时间窗: 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
Clinician Number of Targeted Behaviors Per Visit
时间窗: 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.
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
时间窗: 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.
次要结局
- 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.(8 weeks)
- Difficult Doctor-Patient Relationship Questionnaire(Over a 3-9 month period (depending on how soon after the intervention clinicians' appointments with patient participants can be scheduled).)
- Physicians' overall appraisal of the standardized patient Intervention(1-3 months)
- Change in physician communication self efficacy(Over 3-9 month period (depending on how soon after the intervention clinicians' appointments with patient participants can be scheduled).)
- Patient experience score(8 weeks)
- 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.(8 weeks)
- Patient Experience Score(8 weeks)
- Physicians' Overall Appraisal of the Standardized Patient Intervention(1-3 months)
- Physician Communication Self-efficacy(Over 3-9 month period (depending on how soon after the intervention clinicians' appointments with patient participants can be scheduled).)