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

NCT ID: NCT05067725

Last Updated: 2023-12-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 203 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-06
• Study Completion Date: 2023-01-15

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Control

Standard of practice

Group Type: NO_INTERVENTION

No interventions assigned to this group

CarePath Intervention

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)

Group Type: EXPERIMENTAL

CarePath

Intervention Type: 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.

Interventions

CarePath

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Geisinger Clinic

OTHER

Sponsor Role: lead

Responsible Party

Apoorva Pradhan

Staff Scientist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Apoorva Pradhan, BAMS, MPH

Role: PRINCIPAL_INVESTIGATOR

Geisinger Clinic

Eric Wright, PharmD, MPH

Role: STUDY_DIRECTOR

Geisinger Clinic

Locations

Geisinger Clinic

Danville, Pennsylvania, United States

Countries

United States

Provided Documents

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2021-0729

Identifier Type: -

Identifier Source: org_study_id