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

NCT05067725 | Completed

• 1 other identifier: 2021-0729
• Study Type: interventional
• Target: 203
• Locations: 1 country
• Sites: 1

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.

Conditions

Headache, Migraine; Headache

Keywords

Clinical care evaluation; Primary care

Outcome Measures

Primary Outcomes (1)

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

  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.

  baseline, 3 months and 6 months post baseline

Secondary Outcomes (5)

• 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 proportion of patients who received a prescription for headache medication 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 referral to neurology for headache from baseline to follow up

  baseline, 3 months and 6 months post baseline

Study Arms (2)

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)

Other: CarePath

Interventions

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.

CarePath Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Geisinger Clinic: lead

Study Sites (1)

Geisinger Clinic

Danville, Pennsylvania, 17822, United States

Location

MeSH Terms

Conditions

Migraine Disorders; Headache

Condition Hierarchy (Ancestors)

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

Study Officials

• Apoorva Pradhan, BAMS, MPH

  Geisinger Clinic

  PRINCIPAL INVESTIGATOR

• Eric Wright, PharmD, MPH

  Geisinger Clinic

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Scientist

Model Details: Prospective cluster randomized control study

Study Record Dates

• First Submitted: September 23, 2021
• First Posted: October 5, 2021
• Study Start: December 6, 2021
• Primary Completion: August 11, 2022
• Study Completion: January 15, 2023
• Last Updated: December 20, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)