Department of Rehabilitation Medicine, University of Washington School of Medicine, Seattle.
Department of Neurological Surgery, University of Washington School of Medicine, Seattle.
JAMA Netw Open. 2024 Jun 3;7(6):e2413459. doi: 10.1001/jamanetworkopen.2024.13459.
Chronic pain after traumatic brain injury (TBI) is prevalent and associated with poor outcomes. By providing multidisciplinary care through expert consultation, a collaborative care (CC) treatment approach may reduce pain interference.
To compare CC with usual care (UC) in decreasing pain interference.
DESIGN, SETTING, AND PARTICIPANTS: This randomized clinical trial was conducted from July 2018 through April 2021 at 2 hospital-based academic rehabilitation medicine clinics in Seattle, Washington. Participants included adults with mild-to-severe TBI (at least 6 months before enrollment) and chronic pain. Data analysis was performed from March 30, 2022, to August 30, 2023.
The CC intervention (called TBI Care) included up to 12 in-person or telephone visits over 16 weeks with a care manager (CM) who provided person-centered cognitive behavioral treatment. The CM met weekly with members of the expert team to review participants and discuss recommendations to optimize treatment.
The primary outcome was pain interference on the Brief Pain Inventory at treatment conclusion (4 months after randomization). Secondary outcomes included pain interference at 8 months; pain severity; symptoms of depression, anxiety, and sleep disturbance; pain-related emergency department visits; community participation; and participant satisfaction. Linear mixed-effects regression was used for analysis.
A total of 1379 individuals were screened for eligibility, and 158 were randomized (79 to CC and 79 to UC). The participants were mostly women (92 participants [58%]) with a mean (SD) age of 46.8 (13.2) years and a mean (SD) of 15.3 (3.0) years of education. TBI occurred a mean (SD) of 4.0 (5.9) years (median [IQR], 1.9 [0.8-4.5] years) before enrollment. All TBI severities were included, and of 149 participants for whom TBI severity was known, the majority (97 participants [65%]) had mild TBI. In the CC group, 71 participants (90%) completed at least 11 sessions, and, at 4 months, this group had significantly lower pain interference scores compared with the UC group (mean [SD], 3.46 [2.17] vs 5.03 [2.28]). This difference was maintained at 8 months after randomization, with mean (SD) TBI care pain interference scores of 3.61 (2.22) for CC vs 4.68 (2.51) for UC. At 4 months, there was significantly lower pain severity in the CC group vs UC group (mean [SD] score, 3.63 [1.95] vs 4.90 [1.96]), as well as symptoms of depression (mean [SD] score, 8.07 [5.34] vs 11.31 [6.37]) and anxiety (mean [SD], 6.20 [5.17] vs 9.58 [6.00]). Satisfaction with pain treatment (mean [SD] score, 2.99 [1.23] vs 2.52 [1.25]), clinical care (mean [SD] score, 3.28 [1.00] vs 2.84 [1.26]), and overall health care (mean [SD] score, 3.25 [0.88] vs 2.82 [1.00]) were significantly higher in the CC group vs the UC group; global impression of change was significantly lower in the CC group vs the UC group (mean [SD] score, 2.74 [1.02] vs 3.47 [1.26]) (lower scores denote a better impression of change).
In this randomized clinical trial of CC compared with UC for patients with TBI, CC was effective at reducing pain interference and was sustained at 8-month follow-up. Further research is needed to examine the implementation and cost-effectiveness of CC for TBI in other health care settings.
ClinicalTrials.gov Identifier: NCT03523923.
创伤性脑损伤（TBI）后慢性疼痛很常见，且与不良结局相关。通过专家咨询提供多学科护理，协作护理（CC）治疗方法可能会减少疼痛干扰。
比较 CC 与常规护理（UC）在减少疼痛干扰方面的效果。
设计、设置和参与者：这项随机临床试验于 2018 年 7 月至 2021 年 4 月在西雅图的 2 家医院为基础的康复医学诊所进行，参与者包括患有轻度至重度 TBI（至少在入组前 6 个月）和慢性疼痛的成年人。数据分析于 2022 年 3 月 30 日至 2023 年 8 月 30 日进行。
CC 干预（称为 TBI Care）包括最多 12 次面对面或电话访问，由一名负责提供以患者为中心的认知行为治疗的护理经理（CM）进行。CM 每周与专家团队成员会面，审查参与者并讨论建议，以优化治疗。
主要结局是治疗结束时（随机分组后 4 个月）的简明疼痛量表（Brief Pain Inventory）中的疼痛干扰。次要结局包括 8 个月时的疼痛干扰；疼痛严重程度；抑郁、焦虑和睡眠障碍症状；与疼痛相关的急诊就诊；社区参与度；以及参与者满意度。采用线性混合效应回归进行分析。
共有 1379 人接受了入选资格筛查，其中 158 人被随机分配到 CC 组（79 人）和 UC 组（79 人）。参与者主要为女性（92 人[58%]），平均年龄（SD）为 46.8（13.2）岁，平均受教育年限（SD）为 15.3（3.0）年。TBI 发生的平均（SD）时间为 4.0（5.9）年（中位数[IQR]，1.9 [0.8-4.5]年），在入组前。所有 TBI 严重程度均包括在内，在已知 TBI 严重程度的 149 名参与者中，大多数（97 名参与者[65%]）患有轻度 TBI。在 CC 组中，71 名参与者（90%）完成了至少 11 次就诊，在 4 个月时，该组的疼痛干扰评分明显低于 UC 组（平均[SD]，3.46 [2.17] vs 5.03 [2.28]）。这种差异在随机分组后 8 个月时仍保持，CC 组的 TBI 护理疼痛干扰评分的平均值（SD）为 3.61（2.22），而 UC 组为 4.68（2.51）。在 4 个月时，CC 组的疼痛严重程度明显低于 UC 组（平均[SD]评分，3.63 [1.95] vs 4.90 [1.96]），抑郁症状（平均[SD]评分，8.07 [5.34] vs 11.31 [6.37]）和焦虑（平均[SD]，6.20 [5.17] vs 9.58 [6.00]）也较低。疼痛治疗满意度（平均[SD]评分，2.99 [1.23] vs 2.52 [1.25]）、临床护理满意度（平均[SD]评分，3.28 [1.00] vs 2.84 [1.26]）和整体医疗保健满意度（平均[SD]评分，3.25 [0.88] vs 2.82 [1.00]）在 CC 组中显著高于 UC 组；CC 组的全球印象变化明显低于 UC 组（平均[SD]评分，2.74 [1.02] vs 3.47 [1.26]）（评分越低表示对变化的印象越好）。
在这项对 TBI 患者进行 CC 与 UC 的随机临床试验中，CC 在减少疼痛干扰方面是有效的，且在 8 个月的随访中仍持续有效。需要进一步研究 CC 在其他医疗保健环境中治疗 TBI 的实施和成本效益。
ClinicalTrials.gov 标识符：NCT03523923。
