Telemedicine Versus Traditional Specialist Consultation for Headache: a Non-inferiority Trial

Headaches Clinical Trial

— VHS  

Official title:

Patients` Satisfaction With Telemedicine Versus Traditional Specialist Consultation for Headache. An Open-labeled Randomized Non-inferiority Study Among Patients With Headache Referred to a Neurologic Outpatient Clinic

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02270177
• Other study ID #: 2009/1430 REK sør-øst
• Secondary ID: FAS nr: 692HST95
• Status: Completed
• Phase: N/A
• First received: October 2, 2014
• Last updated: June 13, 2016
• Start date: September 2012
• Est. completion date: June 2016

Study information

• Verified date: May 2016
• Source: University Hospital of North Norway
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research Ethics
• Study type: Interventional

Clinical Trial Summary

Headache is a frequent cause of visits to the GPs office, and the investigators have previously shown that this group accounts for about 20 % of patients referred to a general neurologic outpatient clinic.

To our knowledge, no previous study has investigated whether headache consultation through telemedicine provides equal health care outcomes compared to regular visit to the neurologist. If that's the case, a modern interactive health care system may give simpler and cheaper services for patients, saving travelling costs and community expenses. It may possibly also lead to reduced waiting lists, earlier diagnosis and treatment.

This is an open-labeled randomized non-inferiority trial of headache patients referred to a neurologic clinic in North-Norway. The aim of this study is to determine whether video consultations are non-inferior to regular consultations in diagnosing and treating primary headaches. The null hypothesis is that there is no difference in patient satisfaction between the two groups. The outcome is assessed 3 and 12 months after the neurologic consultation.

Participants will be allocated to either a telemedicine consultation or a regular consultation at the neurologic outpatient clinic in the University Hospital of North-Norway, Tromsø. Both groups will undergo a structured and detailed interview to clarify the diagnosis and establish appropriate treatment. To ensure the best possible representation in the population, our goal is to include at least 70% of all the referred patients that meet the criteria for participation. The randomizations are made through a centralized 8-16 phone line to the research-department in Tromsø, at the University Hospital of North-Norway.

Both primary and secondary endpoints will be assessed in questionnaires sent three and 12 months after the consultation. In addition, the quality of the physicians` referrals and calculations of cost savings by using telemedicine will be evaluated.

The patients' informed consent will always be obtained before data collection. Patients are able to withdraw from the study at any time. Withdrawal will not affect the treatment or follow up. Local research ethics committee (REC) has approved the study.

Description:

Epidemiological research shows that over half of Europe's population suffers from headache. Approximately 11% of the population suffers from migraine, over half of the population have tension-type headache, and 4% have chronic daily headaches. There is clear evidence that headaches, and especially migraines, are under- or misdiagnosed. Headache is a frequent cause of visits to the GPs office, and we have previously shown that this group accounts for about 20 % of patients referred to a general neurologic outpatient clinic.

To our knowledge, no previous studies have investigated whether headache consultations through telemedicine provides equal health care outcomes compared to regular visits to the neurologist. If that's the case, a modern interactive health care system may give simpler and cheaper services for patients, saving traveling costs and community expenses. It may possibly also lead to reduced waiting lists, earlier diagnosis and treatment.

This is an open-label randomized non-inferiority study of headache patients referred to our neurologic outpatient clinic. The aim of this study is to determine if video consultations are non-inferior to regular consultations in diagnosing and treating primary headaches. The null hypothesis is that there is no difference in patient satisfaction between the two groups. The outcome is assessed 3 and 12 months after the neurologic consultation. We will allocate participants to either a telemedicine consultation or a regular consultation at the neurologic outpatient clinic in the University Hospital of North-Norway, Tromsø. Both groups will undergo a structured and detailed interview to clarify the diagnosis and establish appropriate treatment. All diagnoses are given by the most up to date version of The International Classification of Headache Disorders (ICHD). We will strive continuously to include all patients who meet the inclusion and exclusion criteria. To ensure the best possible representation in the population, our goal is to include at least 70% of all the referred patients that meet the criteria for participation in this study. The randomizations are made through a centralized 8-16 phone line to the research-department in Tromsø, at the University Hospital of North-Norway.

We will gather the primary and secondary endpoints from the recruited participants by questionnaires sent three and 12 months after the consultation. In addition, we are going to investigate the quality of the physicians` referrals, peoples` use of medications, alternative therapies as well as calculations of cost savings by using telemedicine.

The patients' informed consent will always be obtained before data collection. Patients are able to withdraw from the study at any time. Withdrawal will not affect the treatment or follow up. Local research ethics committee (REC) has approved the study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 402
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 65 Years

Eligibility

Inclusion Criteria:

• Females and males =16 and =65 years of age

• Referred to a neurologist for headache

• No red flags (defined) suggestive of a secondary cause? No known underlying causes of headaches (secondary headaches) according to established criteria

• Referred for diagnostic clarification and / or treatment

• Waiting time = 4 months from the date of the referral

• speaking Norwegian language

Exclusion Criteria:

• Age <16 years or > 65 years of age

• Known underlying cause of the headache or the presence of red flags suggestive of secondary headaches.

• Examined by a neurologist for headaches in a period of 2 years before referral

• Waited longer than 4 months from the date of referral

• Non-Norwegian speaker

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Headache
• Headaches

Intervention

Other:
• Telemedicine, videoconsultation
We are investigating the use of videoconsultations (through telemedicine technology) in patients with primary headaches.

Locations

Country	Name	City	State
Norway	Department of Neurology, University Hospital of North Norway	Tromsø	Troms

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital of North Norway	University of Tromso

Country where clinical trial is conducted

Norway, 

References & Publications (11)

Bekkelund SI, Albretsen C. Evaluation of referrals from general practice to a neurological department. Fam Pract. 2002 Jun;19(3):297-9. — View Citation

Bekkelund SI, Salvesen R. Is uncertain diagnosis a more frequent reason for referring migraine patients to neurologist than other headache syndromes? Eur J Neurol. 2006 Dec;13(12):1370-3. — View Citation

Bekkelund SI, Salvesen R. Patient satisfaction with a neurological specialist consultation for headache. Scand J Prim Health Care. 2002 Sep;20(3):157-60. — View Citation

Bekkelund SI, Salvesen R; North Norway Headache Study (NNHS). Are headache patients who initiate their referral to a neurologist satisfied with the consultation? A population study of 927 patients--the North Norway Headache Study (NNHS). Fam Pract. 2001 Oct;18(5):524-7. — View Citation

Cottrell C, Drew J, Gibson J, Holroyd K, O'Donnell F. Feasibility assessment of telephone-administered behavioral treatment for adolescent migraine. Headache. 2007 Oct;47(9):1293-302. — View Citation

Headache Classification Subcommittee of the International Headache Society. The International Classification of Headache Disorders: 2nd edition. Cephalalgia. 2004;24 Suppl 1:9-160. — View Citation

Pryse-Phillips W. Evaluating migraine disability: the headache impact test instrument in context. Can J Neurol Sci. 2002 Jun;29 Suppl 2:S11-5. Review. — View Citation

Salvesen R, Bekkelund SI. Aspects of referral care for headache associated with improvement. Headache. 2003 Jul-Aug;43(7):779-83. — View Citation

Stovner LJ, Andree C. Prevalence of headache in Europe: a review for the Eurolight project. J Headache Pain. 2010 Aug;11(4):289-99. doi: 10.1007/s10194-010-0217-0. Epub 2010 May 16. Review. — View Citation

Stovner LJ, Andrée C; Eurolight Steering Committee. Impact of headache in Europe: a review for the Eurolight project. J Headache Pain. 2008 Jun;9(3):139-46. doi: 10.1007/s10194-008-0038-6. Epub 2008 Apr 17. Review. — View Citation

Stovner LJ, Zwart JA, Hagen K, Terwindt GM, Pascual J. Epidemiology of headache in Europe. Eur J Neurol. 2006 Apr;13(4):333-45. Review. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Estimation of travelling distances to the neurologic outpatient clinic	travelling distances in kilometers	travelling distance in kilometers for the neurologic consultation (telemedicine versus regular consultation) and the average travelling distance to the GP during the consecutive 11 months	No
Other	Expenses saved by using telemedicine	Evaluation of the expenses associated with telemedicine compared to regular consultations (travelling expensis, lost earnings, days away from work,	Expenses (travelling, lost income and days absent from work) for the neurologic consultation and the average expenses for GP-consultations during the consecutive 11 months	No
Other	Number of headache days and headaches	Change in number of headache days per month and number of headahces per month	change in number of headaches from baseline, at 3 months and 12 months	No
Other	Change in headache feature	Is the headahce bether, worse or the same. Is the headahce more intens, less intens or unchanged.	Change in headache features from baseline, after 3 months and 12 months	No
Primary	Number of satisfied participants	Are you satisfied with the consultation? Yes/No	change from baseline at 3 months and 12 months	No
Secondary	VAS satisfaction rating scale	Visual analog satisfaction scale 0-10, where 0 = least satisfied and 10 = most satisfied	12 months	No
Secondary	VAS pain scale	Headache measured by a visual analog scale 0-10, 0= no pain, 10=worst pain	changes from baseline in VAS at 3 months and 12 months	No
Secondary	HIT-6	Headache impact test	Changes from baseline in HIT 6 at 3 months and 12 months	No
Secondary	Job situation/occupation	Job situation/occupation	changes from baseline in job situation at 3 months and 12 months	No
Secondary	numbers of consultations during follow up	numbers of GP-consultations, hospital consultations and admissions	numbers of consultations from baseline and after 12 months	No
Secondary	number of pain killers, triptans and other medications for headache	number of medications for headache	at baseline, after 3 months and after 12 months	No
Secondary	headache diagnosis	Headache diagnosis after IHS criteria	at baseline, after 3 months and 12 months	No