Remote ConsultationNCT00298961
Psychiatric Consultation Through Videoconference in a Primary Care Setting
A study testing Videoconference equipment FALCON/IP in people with Remote Consultation and Community Psychiatry, run by Sha'ar Menashe Mental Health Center at 1 site in Israel.
Trial summary
In our study we will aim to examine the issues of cost analysis, quality of life, clinical efficacy and satisfaction of psychiatric consultations through videoconference in a primary care setting in comparison with in-person psychiatric treatment and primary care only. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Remote Consultation, Community Psychiatry
- What is being tested?
- Videoconference equipment FALCON/IP
- Type of treatment
- Medical device
- How many people
- 160 participants
- Where
- 1 siteIsrael
- Study dates
- May 2006to Nov 2007
- 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
- Patients referred by the primary care physician.
- Age 18 and over.
- Speak Hebrew.
Who cannot join
- Patients that suffer from severe dementia.
- Patients suffering from addiction to drugs or alcohol.
- Patients who are deaf, dumb or blind.
- Patients who have a legal guardian.
Trial locations and contacts
1 site in 1 country.
Israel1 site
Sha'ar Menashe Mental Health Center Ambulatory Clinic
Hadera, 38814
Mahmud Jabarin, MD, +972-4-6278110, jabarin@shaar-menashe.org.il
Ehud Susser, MD, +972-4-6278946, udiwudi@yahoo.com
About this study
Official title: Telepsychiatry: Cost Analysis, Quality of Life, Satisfaction and Effectiveness of Psychiatric Consultation Through Videoconference in a Primary Care Setting
In our study we will aim to examine the issues of cost analysis, quality of life, clinical efficacy and satisfaction of psychiatric consultations through videoconference in a primary care setting in comparison with in-person psychiatric treatment and primary care only. The main hypotheses of the study are: Satisfaction of the patients will increase, the use of telepsychiatry will reduce the costs for the primary and mental health care centers as well as for the patients, the treatment will be as effective as in-person treatment, the number of patients referred to mental health treatment will be higher than that of the previous year, quality of life will improve and that there will be a stigma reduction of mental illness.
Read the detailed description
Telepsychiatry, as a method which utilizes videoconferencing as a means for consultation, examination and treatment of patients as a substitute for in-person treatment has been in use now for over 40 years. With telepsychiatry there is an attempt to deal with the issues of providing service to patients who reside at a considerable distance from the mental health facilities or that conversely do not call for mental health services for other diverse reasons such as loss of work days, social stigma, travel expenses and so forth.
In Israel, mental health services are provided to 1.5% of the population whereas the incidence in other developed countries is significantly higher, reaching 3-5%, while the prevalence of mental illness in Israel is similar. One can hypothesize that the above factors such as social stigma, mental health care availability, loss of work days and travel expenses all play a role in this. Consequently, patients may prefer to see their primary care physician as an alternative, and according to reports of the Israeli national health services, 30%-50% of visits to the primary care physician are mental health related. Thanks to the technological advances in telecommunications, especially regarding cost reduction and higher bandwidths, there has been a renewed interest in telepsychiatry. However, the issue of the cost effectiveness of telepsychiatry is still controversial. Out of 380 studies on telepsychiatry published from 1956 to 2002, only 12 dealt with the question of cost effectiveness, and among those the results were equivocal. Another question that has scarcely been studied is that of quality of life within telepsychiatry treatment. Finally, the issue of telepsychiatry that is used as a consultation tool in the aid of the primary physician that occurs physically in his own practice is another novel angle we wish to explore. The advantages embodied in this are potentially many - patient discreteness and confidentiality, decrease in expenses and stigma reduction among others.
In our study we will attempt to address the above issues that have not received the focus of attention in many of the published studies so far - cost analysis and quality of life within the context of telepsychiatry consultation in primary care. Additionally, we will address the issues of clinical efficacy and satisfaction (of the primary care provider as well as that of the patient) from the treatment.
Our study hypotheses are:
- The satisfaction of the patients will increase during the 12 months of study in the group treated by telepsychiatry in comparison with the control groups.
- Cost analysis - the use of telepsychiatry will reduce the costs for the primary health care centers and/or for the mental health centers: Travel expenses, a decrease in visitations to the primary health care center, a decrease in hospitalizations in general hospitals and/or psychiatric hospitals, a decrease in the number of ancillary tests and of lost work days.
- Effectiveness of treatment - the mental and physical well being of the patients will improve or at least not be impaired in the group treated by telepsychiatry as compared to the control groups due to the increased availability of the consultation service.
- The number of patients referred to mental health treatment will be higher than that of the previous year due to the increased availability of telepsychiatry within the primary care setting.
- The patients will prefer the telepsychiatry service as compared to a referral to a mental health center.
- Quality of life will improve or it least not be impaired in the group treated by telepsychiatry as compared to the control groups.
- Stigma reduction - Visitations to the primary health care center as opposed to the mental health center will lower the possibility of the formation of a social stigma of mental disease.
Comparison Groups:
- Telepsychiatry treated patients within the primary care setting.
- In-person treated patients by a psychiatrist at the mental health center.
- Primary care treated patients without a psychiatry consultation.
- Conditions
- Remote Consultation, Community Psychiatry
- Being tested
- Videoconference equipment FALCON/IP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Videoconference equipment FALCON/IPDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Brief Psychiatric Rating Scale (BPRS) at 0 months, 6 months and 12 months.
Secondary outcomes (7)
Clinical Global Impression Scale (CGI) at 0 months, 6 months and 12 months.
Hamilton Anxiety Rating Scale (HAM-A) at 0 months, 6 months and 12 months.
Hamilton Depression Rating Scale (HAM-D) at 0 months, 6 months and 12 months.
Global satisfaction questionnaire at 0 months, 6 months and 12 months.
General Health Questionnaire 11 (GHQ11) at 0 months, 6 months and 12 months.
Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q-18) at 0 months, 6 months and 12 months.
Costs: Travel expenses, extra consultations, hospitalizations, Medication, loss of work days, medical visitations, ancillary tests such as ECG, lab tests and others at 0 months, 6 months and 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2006 (estimated)
- Study startMay 2006
- Study completionNov 2007 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Remote ConsultationStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sha'ar Menashe Mental Health Center
- Sponsor type
- University, hospital or other
- Collaborators
- Galil Center for Telemedicine and Medical Informatics
- Investigators
- Mahmud Jabarin, MD, Principal investigator, Sha'ar Menashe Mental Health Center, IsraelIlan Modai, MD, MHA, Study chair, Sha'ar Menashe Mental Health Center, IsraelEhud Susser, MD, Study chair, Sha'ar Menashe Mental Health Center, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00298961
- Sponsor's protocol ID
- TelepsychiatryCTIL
- Status last verified
- May 2008
- First submitted
- 2 Mar 2006
- Last updated
- 21 May 2008
- Results posted
- No
Publications
Hyler SE, Gangure DP, Batchelder ST. Can telepsychiatry replace in-person psychiatric assessments? A review and meta-analysis of comparison studies. CNS Spectr. 2005 May;10(5):403-13. doi: 10.1017/s109285290002277x.
PubMed 15858458Frueh BC, Deitsch SE, Santos AB, Gold PB, Johnson MR, Meisler N, Magruder KM, Ballenger JC. Procedural and methodological issues in telepsychiatry research and program development. Psychiatr Serv. 2000 Dec;51(12):1522-7. doi: 10.1176/appi.ps.51.12.1522.
PubMed 11097648Hilty DM, Luo JS, Morache C, Marcelo DA, Nesbitt TS. Telepsychiatry: an overview for psychiatrists. CNS Drugs. 2002;16(8):527-48. doi: 10.2165/00023210-200216080-00003.
PubMed 12096934May C, Gask L, Atkinson T, Ellis N, Mair F, Esmail A. Resisting and promoting new technologies in clinical practice: the case of telepsychiatry. Soc Sci Med. 2001 Jun;52(12):1889-901. doi: 10.1016/s0277-9536(00)00305-1.
PubMed 11352414Monnier J, Knapp RG, Frueh BC. Recent advances in telepsychiatry: an updated review. Psychiatr Serv. 2003 Dec;54(12):1604-9. doi: 10.1176/appi.ps.54.12.1604.
PubMed 14645799Williams TL, May CR, Esmail A. Limitations of patient satisfaction studies in telehealthcare: a systematic review of the literature. Telemed J E Health. 2001 Winter;7(4):293-316. doi: 10.1089/15305620152814700.
PubMed 11886667Roine R, Ohinmaa A, Hailey D. Assessing telemedicine: a systematic review of the literature. CMAJ. 2001 Sep 18;165(6):765-71.
PubMed 11584564Simpson J, Doze S, Urness D, Hailey D, Jacobs P. Telepsychiatry as a routine service--the perspective of the patient. J Telemed Telecare. 2001;7(3):155-60. doi: 10.1258/1357633011936318.
PubMed 11346475Yoshino A, Shigemura J, Kobayashi Y, Nomura S, Shishikura K, Den R, Wakisaka H, Kamata S, Ashida H. Telepsychiatry: assessment of televideo psychiatric interview reliability with present- and next-generation internet infrastructures. Acta Psychiatr Scand. 2001 Sep;104(3):223-6. doi: 10.1034/j.1600-0447.2001.00236.x.
PubMed 11531660Dongier M, Tempier R, Lalinec-Michaud M, Meunier D. Telepsychiatry: psychiatric consultation through two-way television. A controlled study. Can J Psychiatry. 1986 Feb;31(1):32-4. doi: 10.1177/070674378603100107.
PubMed 3512068Cruz M, Krupinski EA, Lopez AM, Weinstein RS. A review of the first five years of the University of Arizona telepsychiatry programme. J Telemed Telecare. 2005;11(5):234-9. doi: 10.1258/1357633054471821.
PubMed 16035965Hyler SE, Gangure DP. A review of the costs of telepsychiatry. Psychiatr Serv. 2003 Jul;54(7):976-80. doi: 10.1176/appi.ps.54.7.976.
PubMed 12851433Krupinski EA, Barker G, Lopez AM, Weinstein RS. An analysis of unsuccessful teleconsultations. J Telemed Telecare. 2004;10(1):6-10. doi: 10.1258/135763304322764112.
PubMed 15006208Hilty DM, Marks SL, Urness D, Yellowlees PM, Nesbitt TS. Clinical and educational telepsychiatry applications: a review. Can J Psychiatry. 2004 Jan;49(1):12-23. doi: 10.1177/070674370404900103.
PubMed 14763673Kennedy C, Yellowlees P. A community-based approach to evaluation of health outcomes and costs for telepsychiatry in a rural population: preliminary results. J Telemed Telecare. 2000;6 Suppl 1:S155-7. doi: 10.1258/1357633001934492.
PubMed 10794004
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telepsychiatry: Cost Analysis, Quality of Life, Satisfaction and Effectiveness of Psychiatric Consultation Through Videoconference in a Primary Care Setting
- ClinicalTrials.gov ID
- NCT00298961
- Acronym / sponsor ID
- TelepsychiatryCTIL
- Conditions
- Remote Consultation, Community Psychiatry
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Sha'ar Menashe Mental Health CenterUniversity, hospital or other
- Collaborators
- Galil Center for Telemedicine and Medical Informatics
- Study start
- May 2006
- Study completion
- Nov 2007 (estimated)
- First posted
- 3 Mar 2006 (estimated)
- 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.
In our study we will aim to examine the issues of cost analysis, quality of life, clinical efficacy and satisfaction of psychiatric consultations through videoconference in a primary care setting in comparison with in-person psychiatric treatment and primary care only. The main hypotheses of the study are: Satisfaction of the patients will increase, the use of telepsychiatry will reduce the costs for the primary and mental health care centers as well as for the patients, the treatment will be as effective as in-person treatment, the number of patients referred to mental health treatment will be higher than that of the previous year, quality of life will improve and that there will be a stigma reduction of mental illness.
Detailed description
Telepsychiatry, as a method which utilizes videoconferencing as a means for consultation, examination and treatment of patients as a substitute for in-person treatment has been in use now for over 40 years. With telepsychiatry there is an attempt to deal with the issues of providing service to patients who reside at a considerable distance from the mental health facilities or that conversely do not call for mental health services for other diverse reasons such as loss of work days, social stigma, travel expenses and so forth.
In Israel, mental health services are provided to 1.5% of the population whereas the incidence in other developed countries is significantly higher, reaching 3-5%, while the prevalence of mental illness in Israel is similar. One can hypothesize that the above factors such as social stigma, mental health care availability, loss of work days and travel expenses all play a role in this. Consequently, patients may prefer to see their primary care physician as an alternative, and according to reports of the Israeli national health services, 30%-50% of visits to the primary care physician are mental health related. Thanks to the technological advances in telecommunications, especially regarding cost reduction and higher bandwidths, there has been a renewed interest in telepsychiatry. However, the issue of the cost effectiveness of telepsychiatry is still controversial. Out of 380 studies on telepsychiatry published from 1956 to 2002, only 12 dealt with the question of cost effectiveness, and among those the results were equivocal. Another question that has scarcely been studied is that of quality of life within telepsychiatry treatment. Finally, the issue of telepsychiatry that is used as a consultation tool in the aid of the primary physician that occurs physically in his own practice is another novel angle we wish to explore. The advantages embodied in this are potentially many - patient discreteness and confidentiality, decrease in expenses and stigma reduction among others.
In our study we will attempt to address the above issues that have not received the focus of attention in many of the published studies so far - cost analysis and quality of life within the context of telepsychiatry consultation in primary care. Additionally, we will address the issues of clinical efficacy and satisfaction (of the primary care provider as well as that of the patient) from the treatment.
Our study hypotheses are:
- The satisfaction of the patients will increase during the 12 months of study in the group treated by telepsychiatry in comparison with the control groups.
- Cost analysis - the use of telepsychiatry will reduce the costs for the primary health care centers and/or for the mental health centers: Travel expenses, a decrease in visitations to the primary health care center, a decrease in hospitalizations in general hospitals and/or psychiatric hospitals, a decrease in the number of ancillary tests and of lost work days.
- Effectiveness of treatment - the mental and physical well being of the patients will improve or at least not be impaired in the group treated by telepsychiatry as compared to the control groups due to the increased availability of the consultation service.
- The number of patients referred to mental health treatment will be higher than that of the previous year due to the increased availability of telepsychiatry within the primary care setting.
- The patients will prefer the telepsychiatry service as compared to a referral to a mental health center.
- Quality of life will improve or it least not be impaired in the group treated by telepsychiatry as compared to the control groups.
- Stigma reduction - Visitations to the primary health care center as opposed to the mental health center will lower the possibility of the formation of a social stigma of mental disease.
Comparison Groups:
- Telepsychiatry treated patients within the primary care setting.
- In-person treated patients by a psychiatrist at the mental health center.
- Primary care treated patients without a psychiatry consultation.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients referred by the primary care physician.
- Age 18 and over.
- Speak Hebrew.
Key exclusion criteria (4 listed)
- Patients that suffer from severe dementia.
- Patients suffering from addiction to drugs or alcohol.
- Patients who are deaf, dumb or blind.
- Patients who have a legal guardian.
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 |
|---|---|---|
| Videoconference equipment FALCON/IP | Device | – |
Primary outcome
Brief Psychiatric Rating Scale (BPRS) at 0 months, 6 months and 12 months.
7 secondary outcomes
Clinical Global Impression Scale (CGI) at 0 months, 6 months and 12 months.
Hamilton Anxiety Rating Scale (HAM-A) at 0 months, 6 months and 12 months.
Hamilton Depression Rating Scale (HAM-D) at 0 months, 6 months and 12 months.
Global satisfaction questionnaire at 0 months, 6 months and 12 months.
General Health Questionnaire 11 (GHQ11) at 0 months, 6 months and 12 months.
Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q-18) at 0 months, 6 months and 12 months.
Costs: Travel expenses, extra consultations, hospitalizations, Medication, loss of work days, medical visitations, ancillary tests such as ECG, lab tests and others at 0 months, 6 months and 12 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2008.
- Background: PubMed 15858458Hyler SE, Gangure DP, Batchelder ST. Can telepsychiatry replace in-person psychiatric assessments? A review and meta-analysis of comparison studies. CNS Spectr. 2005 May;10(5):403-13. doi: 10.1017/s109285290002277x.
- Background: PubMed 11097648Frueh BC, Deitsch SE, Santos AB, Gold PB, Johnson MR, Meisler N, Magruder KM, Ballenger JC. Procedural and methodological issues in telepsychiatry research and program development. Psychiatr Serv. 2000 Dec;51(12):1522-7. doi: 10.1176/appi.ps.51.12.1522.
- Background: PubMed 12096934Hilty DM, Luo JS, Morache C, Marcelo DA, Nesbitt TS. Telepsychiatry: an overview for psychiatrists. CNS Drugs. 2002;16(8):527-48. doi: 10.2165/00023210-200216080-00003.
- Background: PubMed 11352414May C, Gask L, Atkinson T, Ellis N, Mair F, Esmail A. Resisting and promoting new technologies in clinical practice: the case of telepsychiatry. Soc Sci Med. 2001 Jun;52(12):1889-901. doi: 10.1016/s0277-9536(00)00305-1.
- Background: PubMed 14645799Monnier J, Knapp RG, Frueh BC. Recent advances in telepsychiatry: an updated review. Psychiatr Serv. 2003 Dec;54(12):1604-9. doi: 10.1176/appi.ps.54.12.1604.
- Background: PubMed 11886667Williams TL, May CR, Esmail A. Limitations of patient satisfaction studies in telehealthcare: a systematic review of the literature. Telemed J E Health. 2001 Winter;7(4):293-316. doi: 10.1089/15305620152814700.
- Background: PubMed 11584564Roine R, Ohinmaa A, Hailey D. Assessing telemedicine: a systematic review of the literature. CMAJ. 2001 Sep 18;165(6):765-71.
- Background: PubMed 11346475Simpson J, Doze S, Urness D, Hailey D, Jacobs P. Telepsychiatry as a routine service--the perspective of the patient. J Telemed Telecare. 2001;7(3):155-60. doi: 10.1258/1357633011936318.
- Background: PubMed 11531660Yoshino A, Shigemura J, Kobayashi Y, Nomura S, Shishikura K, Den R, Wakisaka H, Kamata S, Ashida H. Telepsychiatry: assessment of televideo psychiatric interview reliability with present- and next-generation internet infrastructures. Acta Psychiatr Scand. 2001 Sep;104(3):223-6. doi: 10.1034/j.1600-0447.2001.00236.x.
- Background: PubMed 3512068Dongier M, Tempier R, Lalinec-Michaud M, Meunier D. Telepsychiatry: psychiatric consultation through two-way television. A controlled study. Can J Psychiatry. 1986 Feb;31(1):32-4. doi: 10.1177/070674378603100107.
- Background: PubMed 16035965Cruz M, Krupinski EA, Lopez AM, Weinstein RS. A review of the first five years of the University of Arizona telepsychiatry programme. J Telemed Telecare. 2005;11(5):234-9. doi: 10.1258/1357633054471821.
- Background: PubMed 12851433Hyler SE, Gangure DP. A review of the costs of telepsychiatry. Psychiatr Serv. 2003 Jul;54(7):976-80. doi: 10.1176/appi.ps.54.7.976.
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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.
Mahmud Jabarin, MD principal investigator
Sha'ar Menashe Mental Health Center, Israel
Ilan Modai, MD, MHA study chair
Sha'ar Menashe Mental Health Center, Israel
Ehud Susser, MD study chair
Sha'ar Menashe Mental Health Center, Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Videoconference equipment FALCON/IP in people with Remote Consultation and Community Psychiatry, run by Sha'ar Menashe Mental Health Center at 1 site in Israel.
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 3 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: status not confirmed, as of the sponsor's last update on 21 May 2008. 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 Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mahmud Jabarin, MD (+972-4-6278110, jabarin@shaar-menashe.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brief Psychiatric Rating Scale (BPRS) at 0 months, 6 months and 12 months.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00298961, which also lists 15 linked publications.
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 21 May 2008.