Headache, MigraineNCT05067725
Evaluating the Effectiveness of a Headache Management Program in Primary Care Settings
A study testing CarePath in people with Headache, Migraine and Headache, run by Geisinger Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Headache, Migraine, Headache
- What is being tested?
- CarePath
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 203 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Dec 2021to 15 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluating the Effectiveness of Migraine CarePath
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
- Being tested
- CarePath
- Keywords
- Clinical care evaluation, Primary care
- Medical subject headings
- Migraine Disorders, Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CarePathOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Other: CarePath |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline, 3 months and 6 months post baseline
Secondary outcomes (5)
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.
Measured: baseline, 3 months and 6 months post baseline
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.
Measured: 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
Proportion of patients who receive a prescription for either of the medications listed below:
- Abortive
- Preventative
- CGRPi
Measured: baseline, 3 months and 6 months post baseline
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
Measured: 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
Proportion of patients who were referred to neurology for headache
Measured: baseline, 3 months and 6 months post baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2021
- Study start6 Dec 2021
- Primary completion11 Aug 2022
- Study completion15 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Headache, MigraineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective cluster randomized control study
- Masking
- None (open label)
- Enrolment
- 203 participants (actual)
Sponsor and investigators
- Lead sponsor
- Geisinger Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Apoorva Pradhan, Geisinger Clinic
- Investigators
- Apoorva Pradhan, BAMS, MPH, Principal investigator, Geisinger ClinicEric Wright, PharmD, MPH, Study director, Geisinger Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05067725
- Sponsor's protocol ID
- 2021-0729
- Status last verified
- Dec 2023
- First submitted
- 23 Sep 2021
- Last updated
- 20 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Other researchers can request access to data collected from study participants by reaching out to the P.I.
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Effectiveness of Migraine CarePath
- ClinicalTrials.gov ID
- NCT05067725
- Acronym / sponsor ID
- 2021-0729
- Conditions
- Headache, Migraine, Headache
- Keywords
- Clinical care evaluation, Primary care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 203 participants (actual)
- Lead sponsor
- Geisinger ClinicUniversity, hospital or other
- Study start
- 6 Dec 2021 (actual)
- Primary completion
- 11 Aug 2022 (actual)
- Study completion
- 15 Jan 2023 (actual)
- First posted
- 5 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective cluster randomized control study
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Standard of practice |
| CarePath Intervention | Experimental | Other: CarePathClinician 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CarePathDuring 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. | Other | CarePath Intervention |
Primary outcome
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.
5 secondary outcomes
Change in headache frequency from baseline to follow up
Time frame: baseline, 3 months and 6 months post baseline
Change in pain intensity score from baseline to follow up
Time frame: 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
Time frame: baseline, 3 months and 6 months post baseline
Change in the number of emergency department visits from baseline to follow up
Time frame: 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
Time frame: baseline, 3 months and 6 months post baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2023.
- Individual participant dataSharing planned: No. Other researchers can request access to data collected from study participants by reaching out to the P.I.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Apoorva Pradhan, BAMS, MPH principal investigator
Geisinger Clinic
Eric Wright, PharmD, MPH study director
Geisinger Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CarePath in people with Headache, Migraine and Headache, run by Geisinger Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Headache Impact Test-6 (HIT-6) score from baseline to follow up (time frame: baseline, 3 months and 6 months post baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2023.