Effective Screening for Pain Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 569
- 试验地点
- 6
- 主要终点
- Arm 1 (NRS Now), to Arm 2 (PEG), to Arm 3 (Defense Veterans Pain Rating Scale (e.g.,DVPRS) Differences Baseline Overall Pain Compared With Gold Standard Chronic Pain Grade Questionnaire Intensity Subscale Items (e.g., CPG Scale, Pain Intensity)
研究概览
简要总结
In light of the importance of pain and widespread interest in patient-centeredness, the Department of Veterans Affairs (VA) has been emphasizing and successfully making pain and its management a routine feature of the health record and a focus of care. Awareness of pain and efforts to improve pain management rest on the VA's '5th Vital Sign' - a policy and practice of nursing staff routinely screening for 'pain now' at every health encounter using a 0-10 Numeric Rating Scale (NRS).
The team's previous research on VA's '5th Vital Sign' informs the specific design of this Effective Screening for Pain (ESP) study as well as the proposed research products.
Alternatives to the current pain screening approach may improve the sensitivity and specificity of screening for chronic pain. These alternatives include the nurse administered NRS with a one week look back period and a three item scale (PEG) incorporating intensity and emotional and physical interference. The PEG is very similar to the gold standard Brief Pain Inventory (BPI) from which it is derived, in its sensitivity, specificity, and sensitivity to change in detecting clinically important, functionally impairing pain.
The investigators plan to evaluate alternatives to the VA's current '5th Vital Sign' for pain screening, focusing on simple, feasible measures that can be used cross-sectionally for pain screening. In the setting of a primary care clinic, the investigators plan to cross-sectionally evaluate three arms - a tablet based DVPRS, a tablet computer-based NRS one week, and a tablet computer-based PEG. All arms will be compared with the nurse administered NRS.
详细描述
Background:
In light of the importance of pain and widespread interest in patient-centeredness, the Department of Veterans Affairs (VA) has been emphasizing and successfully making pain and its management a routine feature of the health record and a focus of care. Awareness of pain and efforts to improve pain management rest on the VA's '5th Vital Sign' - a policy and practice of nursing staff routinely screening for 'pain now' at every health encounter using a 0-10 Numeric Rating Scale (NRS).
The team's previous research on VA's '5th Vital Sign' informs the specific design of this Effective Screening for Pain (ESP) study as well as the proposed research products.
Alternatives to the current pain screening approach may improve the sensitivity and specificity of screening for chronic pain. These alternatives include the nurse administered NRS with a one week look back period and a three item scale (PEG) incorporating intensity and emotional and physical interference.
The investigators plan to evaluate alternatives to the VA's current '5th Vital Sign' for pain screening, focusing on simple, feasible measures that can be used cross-sectionally for pain screening. In the setting of a primary care clinic, the investigators plan to cross-sectionally evaluate three arms - a tablet based DVPRS, a tablet computer-based NRS one week, and a tablet computer-based PEG. All arms will be compared with the nurse administered pain now.
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
- Single (Outcomes Assessor)
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
- •All Veterans are eligible to participate in the clinical trial when presenting for routine care in the primary care clinic at all sites (VA at Palo Alto, Minneapolis, and Portland).
- •All are eligible who do not opt out of participation.
- •All participants in the baseline tablet intervention will also be eligible for a one week follow up telephone interview - unless they are unable to complete a phone interview (see exclusions).
- •For the qualitative Veteran component, all Veterans who can hear and respond in an interview are eligible.
- •Providers/staff must be clinic and facility staff including administrative clerks, regular part time or full time employees in primary care who routinely participate in the care of Veterans who have painful conditions.
排除标准
- •Veterans who meet either of the following exclusion criteria that may interfere with outcome assessment will be ineligible for the follow up telephone interview:
- •a) no working telephone (home, office, or mobile)
- •b) hearing impaired and unable to complete a phone survey
研究组 & 干预措施
tablet based NRS pain one week, followed by nurse pain screen
tablet-based patient self-report of the 'NRS pain one week'
干预措施: NRS pain one week (Behavioral)
DVPRS, followed by nurse pain screen
Defense Veterans Pain Rating Scale on tablet followed by usual nursing staff documented pain screening with NRS pain now
干预措施: DVPRS (Behavioral)
tablet based PEG, followed by nurse pain screen
tablet-based enhanced pain screening with the PEG (pain intensity, emotional, and functional pain interference)
干预措施: PEG (Behavioral)
结局指标
主要结局
Arm 1 (NRS Now), to Arm 2 (PEG), to Arm 3 (Defense Veterans Pain Rating Scale (e.g.,DVPRS) Differences Baseline Overall Pain Compared With Gold Standard Chronic Pain Grade Questionnaire Intensity Subscale Items (e.g., CPG Scale, Pain Intensity)
时间窗: Baseline (e.g., time of clinic visit) measures were cross sectionally assessed
pain (Numeric Rating Scale - NRS and PEG (full scale name) and Defense Veterans Pain Rating Scale - DVPRS measures) using overall pain derived from each of the three measures compared cross sectionally with the three pain intensity items and scale of the Chronic Pain Grade (CPG) questionnaire. The latter addresses pain 'now', average pain, and worst pain. All measures (NRS, PEG, DVPRS, and CPG) are scored from 0-10 where 0 equals no pain and 10 equals worst possible pain.). the NRS is a one item pain intensity measure, the PEG is a 3 item measure combining pain intensity, pain-related emotional and functional interference, and the DVPRS integrates pain intensity, pain interference, faces pain, and colormetric indicators on a 0-10 overall pain scale. The study used no subscales for the NRS, PEG, or DVPRS, and all values reported are total measure scores, computed as the average of items. We compare them to the pain intensity score of the CPG. Higher scores signify worse pain.
次要结局
- Arm 1 (NRS Now), to Arm 2 (PEG), to Arm 3 (DVPRS) Differences in Number of Individuals Who Failed to Complete Pain Screen(Baseline cross sectional comparison at the time of clinic visit)
- Arm 1 (NRS Now), to Arm 2 (PEG), to Arm 3 (DVPRS) Number of Participants Who Rated Overall Functional Status Worse Relative to Peers Using the Gill Single Item Questionnaire(Baseline cross-sectional comparison at time of clinic visit)