Clinical trial NCT05067725: Evaluating the Effectiveness of a Headache Management Program in Primary Care Settings
Official title: Evaluating the Effectiveness of Migraine CarePath
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Headache, Migraine
Headache
Keywords: Clinical care evaluation
Primary care
Lead sponsor: Geisinger Clinic
Sponsor class: OTHER
First posted: 2021-10-05
Enrollment: 203
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective cluster randomized control study
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change in Headache Impact Test-6 (HIT-6) score from baseline to follow up
timeFrame: baseline, 3 months and 6 months post baseline
Secondary outcomes:
measure: Change in headache frequency from baseline to follow up
timeFrame: baseline, 3 months and 6 months post baseline
measure: Change in pain intensity score from baseline to follow up
timeFrame: baseline, 3 months and 6 months post baseline
measure: Change in the proportion of patients who received a prescription for headache medication from baseline to follow up
timeFrame: baseline, 3 months and 6 months post baseline
measure: Change in the number of emergency department visits from baseline to follow up
timeFrame: baseline, 3 months and 6 months post baseline
measure: Change in the proportion of patients who received a referral to neurology for headache from baseline to follow up
timeFrame: baseline, 3 months and 6 months post baseline
Other outcomes:
Locations:
city: Danville
country: United States
facility: Geisinger Clinic
state: Pennsylvania
Study officials:
affiliation: Geisinger Clinic
name: Apoorva Pradhan, BAMS, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Geisinger Clinic
name: Eric Wright, PharmD, MPH
role: STUDY_DIRECTOR
References: