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临床试验/NCT05067725
NCT05067725已完成不适用

Evaluating the Effectiveness of Migraine CarePath

Geisinger Clinic1 个研究点 分布在 1 个国家目标入组 203 人开始时间: 2021年12月6日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
203
试验地点
1
主要终点
Change in Headache Impact Test-6 (HIT-6) score from baseline to follow up

研究概览

简要总结

Between January 2020 to August 2021, fifty percent of patients referred from Geisinger's primary care sites to Neurology for headaches did not trial appropriate first line therapy prior to referral, and there was limited access available at Geisinger's Neurology department. This project was initiated to improve patient experience, management of headache, and provider experience as it relates to headache management. Geisinger's Neurology department, pharmacy department, and Community Medicine Service Line (CMSL) sites have collaborated to develop a Headache CarePath (i.e., a best practice alert containing: an EPIC headache assessment, Express Lane for prescriptions, and Ask-a-doc button for Neurology consult) and piloted at 2 CMSL sites (Woodbine, Selinsgrove) to gain some initial feedback. The feedback has been incorporated into best practice alert (BPA) language and criteria. The project team now plans to implement this CarePath to half of CMSL sites first while the other half of CMSL sites will continue to practice the standard of care as of today. The team will evaluate the impact of this CarePath on patient outcomes [change in Headache Impact Test-6 (HIT-6) scores, change in the frequency of headaches, and change in pain intensity], emergency department (ED) visits, number of referrals to Neurology for headache, and prescribing of headache medications by comparing the measures in clinics that had the CarePath implemented to those that did not. Patient outcomes will be collected by Geisinger's Survey Core, which will reach out telephonically to patients to ask about the status of their headaches (HIT-6, frequency, intensity of headaches, M-TOQ-5). Other measures will be collected and analyzed using secondary data sources such as electronic health record (EHR) data. The initial implementation is planned for 6-9 months. The findings from this evaluation will help the CarePath team identify any remaining opportunities or guide the direction of its future enhancements of the CarePath tools. The results of this evaluation will be shared with the Geisinger leadership to demonstrate its value to the organization.

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

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

  • •Adult patients ≥ 18 years of age for whom the Headache BPA fires at the time for their PCP encounter
  • •New or returning patients with headache as visit diagnosis or chief complaint for the office visit or telemedicine encounter
  • •Have a minimum baseline HIT-6 score of ≥ 50 points OR
  • •Headache frequency of ≥ 12 days with headache or migraine complaint in the last 3 months

排除标准

  • •Patients at the pilot sites (i.e., woodbine, selinsgrove)
  • •Patients diagnosed with secondary headache disorders (eg, brain tumors) or serious systemic illness (eg, uncontrolled hypertension, hepatic or renal failure, cardiac failure) or acute infectious illness (eg, flu, sinusitis).
  • •Patients with headaches as a symptom due to fall/injury
  • •Pregnant women

研究组 & 干预措施

Control

No Intervention

Standard of practice

CarePath Intervention

Experimental

Clinician decision support computer tool that consists of a best practice alert (BPA) embedded with a headache questionnaire, Medication Express Lane (for medication ordering), and Ask-a-doc button (for prompt virtual consultation with a neurologist)

干预措施: CarePath (Other)

结局指标

主要结局

Change in Headache Impact Test-6 (HIT-6) score from baseline to follow up

时间窗: baseline, 3 months and 6 months post baseline

A global measure of adverse headache impact. The final HIT-6 score is obtained from simple summation of the six items and ranges between 36 and 78, with larger scores reflecting greater impact.

次要结局

  • Change in the proportion of patients who received a referral to neurology for headache from baseline to follow up(baseline, 3 months and 6 months post baseline)
  • Change in headache frequency from baseline to follow up(baseline, 3 months and 6 months post baseline)
  • Change in pain intensity score from baseline to follow up(baseline, 3 months and 6 months post baseline)
  • Change in the number of emergency department visits from baseline to follow up(baseline, 3 months and 6 months post baseline)
  • Change in the proportion of patients who received a prescription for headache medication from baseline to follow up(baseline, 3 months and 6 months post baseline)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Apoorva Pradhan

Staff Scientist

Geisinger Clinic

研究点 (1)

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