Division of General Internal Medicine and Primary Care, Brigham and Women's Hospital, Boston, MA, USA.
Harvard Medical School, Boston, MA, USA.
J Gen Intern Med. 2019 Feb;34(2):285-292. doi: 10.1007/s11606-018-4672-7. Epub 2018 Oct 5.
Medication adverse events are important and common yet are often not identified by clinicians. We evaluated an automated telephone surveillance system coupled with transfer to a live pharmacist to screen potentially drug-related symptoms after newly starting medications for four common primary care conditions: hypertension, diabetes, depression, and insomnia.
Cluster randomized trial with automated calls to eligible patients at 1 and 4 months after starting target drugs from intervention primary care clinics compared to propensity-matched patients from control clinics. Primary and secondary outcomes were physician documentation of any adverse effects associated with newly prescribed target medication, and whether the medication was discontinued and, if yes, whether the reason for stopping was an adverse effect.
Of 4876 eligible intervention clinic patients who were contacted using automated calls, 776 (15.1%) responded and participated in the automated call. Based on positive symptom responses or request to speak to a pharmacist, 320 patients were transferred to the pharmacist and discussed 1021 potentially drug-related symptoms. Of these, 188 (18.5%) were assessed as probably and 479 (47.1%) as possibly related to the medication. Compared to a propensity-matched cohort of control clinic patients, intervention patients were significantly more likely to have adverse effects documented in the medical record by a physician (277 vs. 164 adverse effects, p < 0.0001, and 177 vs. 122 patients discontinued with documented adverse effects, p < 0.0001).
Systematic automated telephone outreach monitoring coupled with real-time phone referral to a pharmacist identified a substantial number of previously unidentified potentially drug-related symptoms, many of which were validated as probably or possibly related to the drug by the pharmacist or their physicians. Multiple challenges were encountered using the interactive voice response (IVR) automated calling system, suggesting that other approaches may need to be considered and evaluated.
ClinicalTrials.gov : NCT02087293.
药物不良反应很重要且常见，但临床医生往往无法识别。我们评估了一种自动化电话监测系统，该系统与药师实时转接相结合，用于筛查新开始使用四种常见初级保健药物后可能与药物相关的症状：高血压、糖尿病、抑郁症和失眠。
这是一项采用集群随机试验设计，将干预组初级保健诊所中开始目标药物治疗 1 个月和 4 个月后符合条件的患者与对照组诊所中匹配的患者进行自动电话随访。主要和次要结局是医生记录与新处方目标药物相关的任何不良反应，以及是否停止用药，如果是，停药的原因是否是不良反应。
在对符合条件的 4876 名干预诊所患者进行自动化电话随访中，有 776 名（15.1%）患者进行了回复并参与了自动化电话随访。基于阳性症状反应或要求与药师通话，有 320 名患者被转介给药师，并讨论了 1021 种可能与药物相关的症状。其中，188 种（18.5%）被评估为可能与药物相关，479 种（47.1%）可能与药物相关。与匹配的对照组患者相比，干预组患者的医疗记录中更有可能记录到药物不良反应（277 例与 164 例不良反应，p<0.0001；177 例与 122 例因药物不良反应停药的患者，p<0.0001）。
系统的自动化电话随访监测加上实时电话转介给药师，发现了大量以前未识别的可能与药物相关的症状，其中许多症状经药师或医生确认为可能或可能与药物相关。在使用交互式语音应答（IVR）自动呼叫系统时遇到了多个挑战，这表明可能需要考虑并评估其他方法。
ClinicalTrials.gov：NCT02087293。
