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Completed

NCT Number: NCT05067725

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

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.

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Key information

Conditions

Headache, Migraine Brain Diseases Central Nervous System Diseases Headache Headache Disorders Headache Disorders, Primary Migraine Disorders Nervous System Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Geisinger Clinic

Danville, Pennsylvania, 17822, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CarePath

Other

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.

Primary outcomes

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

    Time frame: 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.

Secondary outcomes

  1. Change in headache frequency from baseline to follow up

    Time frame: baseline, 3 months and 6 months post baseline

    Headache frequency will be measured as the number of days in the last 3 months the patient experiences a headache.

  2. Change in pain intensity score from baseline to follow up

    Time frame: baseline, 3 months and 6 months post baseline

    Headache 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.

  3. Change in the proportion of patients who received a prescription for headache medication from baseline to follow up

    Time frame: baseline, 3 months and 6 months post baseline

    Proportion of patients who receive a prescription for either of the medications listed below:

    • Abortive
    • Preventative
    • CGRPi

  4. Change in the number of emergency department visits from baseline to follow up

    Time frame: baseline, 3 months and 6 months post baseline

    Number of patients who experience an emergency department encounter for any of the causes listed below:

    • All-cause
    • Headache-associated

  5. Change in the proportion of patients who received a referral to neurology for headache from baseline to follow up

    Time frame: baseline, 3 months and 6 months post baseline

    Proportion of patients who were referred to neurology for headache

Sponsors and collaborators

Lead sponsor

Geisinger Clinic

Other

Registry information

Official study title

Evaluating the Effectiveness of Migraine CarePath

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Oct 5, 2021
Registry last updated
Dec 20, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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