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Evaluating the Effectiveness of a Headache Management Program in Primary Care Settings

Evaluating the Effectiveness of Migraine CarePath

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05067725
Enrollment
203
Registered
2021-10-05
Start date
2021-12-06
Completion date
2023-01-15
Last updated
2023-12-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Headache, Headache, Migraine

Keywords

Clinical care evaluation, Primary care

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.

Interventions

During an in-clinic patient encounter with a primary care provider (PCP) in any one of the intervention CMSL sites, the BPA is fired when any type of headache or migraine is entered as a diagnosis or chief complaint. The purpose of the headache assessment questionnaire is to assist the PCP in characterizing patients' headache. The Express Lane will help guide PCP decision-making for prescribing medications, lab/image ordering, and referrals. The Ask-a-doc button will provide timely access to a virtual treatment and diagnosis consult with a neurologist.

Sponsors

Geisinger Clinic
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Intervention model description

Prospective cluster randomized control study

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in Headache Impact Test-6 (HIT-6) score from baseline to follow upbaseline, 3 months and 6 months post baselineA 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.

Secondary

MeasureTime frameDescription
Change in headache frequency from baseline to follow upbaseline, 3 months and 6 months post baselineHeadache frequency will be measured as the number of days in the last 3 months the patient experiences a headache.
Change in pain intensity score from baseline to follow upbaseline, 3 months and 6 months post baselineHeadache pain intensity will be assessed using a visual analog scale 0 - 10, where 0=no pain at all, and 10=pain as bad as it can be.
Change in the proportion of patients who received a prescription for headache medication from baseline to follow upbaseline, 3 months and 6 months post baselineProportion of patients who receive a prescription for either of the medications listed below: * Abortive * Preventative * CGRPi
Change in the number of emergency department visits from baseline to follow upbaseline, 3 months and 6 months post baselineNumber of patients who experience an emergency department encounter for any of the causes listed below: * All-cause * Headache-associated
Change in the proportion of patients who received a referral to neurology for headache from baseline to follow upbaseline, 3 months and 6 months post baselineProportion of patients who were referred to neurology for headache

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026