Disparities Research Unit, Department of Medicine, Massachusetts General Hospital, Boston.
Department of Medicine, Harvard Medical School, Boston, Massachusetts.
JAMA Psychiatry. 2018 Apr 1;75(4):325-335. doi: 10.1001/jamapsychiatry.2017.4585.
Few randomized clinical trials have been conducted with ethnic/racial minorities to improve shared decision making (SDM) and quality of care.
To test the effectiveness of patient and clinician interventions to improve SDM and quality of care among an ethnically/racially diverse sample.
DESIGN, SETTING, AND PARTICIPANTS: This cross-level 2 × 2 randomized clinical trial included clinicians at level 2 and patients (nested within clinicians) at level 1 from 13 Massachusetts behavioral health clinics. Clinicians and patients were randomly selected at each site in a 1:1 ratio for each 2-person block. Clinicians were recruited starting September 1, 2013; patients, starting November 3, 2013. Final data were collected on September 30, 2016. Data were analyzed based on intention to treat.
The clinician intervention consisted of a workshop and as many as 6 coaching telephone calls to promote communication and therapeutic alliance to improve SDM. The 3-session patient intervention sought to improve SDM and quality of care.
The SDM was assessed by a blinded coder based on clinical recordings, patient perception of SDM and quality of care, and clinician perception of SDM.
Of 312 randomized patients, 212 (67.9%) were female and 100 (32.1%) were male; mean (SD) age was 44.0 (15.0) years. Of 74 randomized clinicians, 56 (75.7%) were female and 18 (4.3%) were male; mean (SD) age was 39.8 (12.5) years. Patient-clinician pairs were assigned to 1 of the following 4 design arms: patient and clinician in the control condition (n = 72), patient in intervention and clinician in the control condition (n = 68), patient in the control condition and clinician in intervention (n = 83), or patient and clinician in intervention (n = 89). All pairs underwent analysis. The clinician intervention significantly increased SDM as rated by blinded coders using the 12-item Observing Patient Involvement in Shared Decision Making instrument (b = 4.52; SE = 2.17; P = .04; Cohen d = 0.29) but not as assessed by clinician or patient. More clinician coaching sessions (dosage) were significantly associated with increased SDM as rated by blinded coders (b = 12.01; SE = 3.72; P = .001; Cohen d = 0.78). The patient intervention significantly increased patient-perceived quality of care (b = 2.27; SE = 1.16; P = .05; Cohen d = 0.19). There was a significant interaction between patient and clinician dosage (b = 7.40; SE = 3.56; P = .04; Cohen d = 0.62), with the greatest benefit when both obtained the recommended dosage.
The clinician intervention could improve SDM with minority populations, and the patient intervention could augment patient-reported quality of care.
clinicaltrials.gov Identifier: NCT01947283.
很少有针对少数民族的随机临床试验来改善共同决策（SDM）和医疗质量。
测试患者和临床医生干预措施在种族多样化的样本中改善 SDM 和医疗质量的效果。
设计、设置和参与者：这是一项跨水平的 2×2 随机临床试验，包括来自马萨诸塞州 13 家行为健康诊所的 2 级临床医生和 1 级患者（嵌套在临床医生中）。临床医生和患者以每个 2 人的块为单位，在每个地点以 1:1 的比例随机选择。临床医生于 2013 年 9 月 1 日开始招募，患者于 2013 年 11 月 3 日开始招募。最终数据于 2016 年 9 月 30 日收集。根据意向治疗进行数据分析。
临床医生的干预措施包括一个研讨会和多达 6 次辅导电话，以促进沟通和治疗联盟，从而改善 SDM。三阶段患者干预旨在改善 SDM 和医疗质量。
盲法编码员根据临床记录、患者对 SDM 和医疗质量的感知以及临床医生对 SDM 的感知评估 SDM。
在 312 名随机患者中，212 名（67.9%）为女性，100 名（32.1%）为男性；平均（SD）年龄为 44.0（15.0）岁。在 74 名随机临床医生中，56 名（75.7%）为女性，18 名（4.3%）为男性；平均（SD）年龄为 39.8（12.5）岁。患者-临床医生对被分配到以下 4 种设计臂之一：患者和临床医生在对照组（n=72），患者在干预组而临床医生在对照组（n=68），患者在对照组而临床医生在干预组（n=83），或患者和临床医生在干预组（n=89）。所有配对都进行了分析。临床医生的干预措施显著增加了盲法编码员使用 12 项观察患者参与共同决策工具评估的 SDM（b=4.52；SE=2.17；P=.04；Cohen d=0.29），但不是由临床医生或患者评估的。更多的临床医生辅导次数（剂量）与盲法编码员评估的 SDM 显著增加相关（b=12.01；SE=3.72；P=.001；Cohen d=0.78）。患者干预措施显著增加了患者感知的医疗质量（b=2.27；SE=1.16；P=.05；Cohen d=0.19）。患者和临床医生剂量之间存在显著的相互作用（b=7.40；SE=3.56；P=.04；Cohen d=0.62），当两者都获得推荐剂量时，效果最大。
临床医生的干预措施可以改善少数民族的 SDM，而患者的干预措施可以提高患者报告的医疗质量。
clinicaltrials.gov 标识符：NCT01947283。
