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

Primary Purpose

Headache, Migraine, Headache

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CarePath
Sponsored by
Geisinger Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Headache, Migraine focused on measuring Clinical care evaluation, Primary care

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Geisinger Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

CarePath Intervention

Arm Description

Standard of practice

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)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change in headache frequency from baseline to follow up
Headache 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 up
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.
Change in the proportion of patients who received a prescription for headache medication from baseline to follow up
Proportion 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 up
Number 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 up
Proportion of patients who were referred to neurology for headache

Full Information

First Posted
September 23, 2021
Last Updated
July 17, 2023
Sponsor
Geisinger Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT05067725
Brief Title
Evaluating the Effectiveness of a Headache Management Program in Primary Care Settings
Official Title
Evaluating the Effectiveness of Migraine CarePath
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
December 6, 2021 (Actual)
Primary Completion Date
August 11, 2022 (Actual)
Study Completion Date
January 15, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Geisinger Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Headache, Migraine, Headache
Keywords
Clinical care evaluation, Primary care

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective cluster randomized control study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
206 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
Standard of practice
Arm Title
CarePath Intervention
Arm Type
Experimental
Arm Description
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)
Intervention Type
Other
Intervention Name(s)
CarePath
Intervention Description
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 Outcome Measure Information:
Title
Change in Headache Impact Test-6 (HIT-6) score from baseline to follow up
Description
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.
Time Frame
baseline, 3 months and 6 months post baseline
Secondary Outcome Measure Information:
Title
Change in headache frequency from baseline to follow up
Description
Headache frequency will be measured as the number of days in the last 3 months the patient experiences a headache.
Time Frame
baseline, 3 months and 6 months post baseline
Title
Change in pain intensity score from baseline to follow up
Description
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.
Time Frame
baseline, 3 months and 6 months post baseline
Title
Change in the proportion of patients who received a prescription for headache medication from baseline to follow up
Description
Proportion of patients who receive a prescription for either of the medications listed below: Abortive Preventative CGRPi
Time Frame
baseline, 3 months and 6 months post baseline
Title
Change in the number of emergency department visits from baseline to follow up
Description
Number of patients who experience an emergency department encounter for any of the causes listed below: All-cause Headache-associated
Time Frame
baseline, 3 months and 6 months post baseline
Title
Change in the proportion of patients who received a referral to neurology for headache from baseline to follow up
Description
Proportion of patients who were referred to neurology for headache
Time Frame
baseline, 3 months and 6 months post baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Apoorva Pradhan, BAMS, MPH
Organizational Affiliation
Geisinger Clinic
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Eric Wright, PharmD, MPH
Organizational Affiliation
Geisinger Clinic
Official's Role
Study Director
Facility Information:
Facility Name
Geisinger Clinic
City
Danville
State/Province
Pennsylvania
ZIP/Postal Code
17822
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Other researchers can request access to data collected from study participants by reaching out to the P.I.

Learn more about this trial

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

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