SchizophreniaNCT02435784
The Two-Way Communication Checklist (2-COM) in First Episode Psychosis Patients in Hong Kong
A study testing The Two-Way Communication Checklist and Treatment as usual in people with Schizophrenia and Communication, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
The Two-Way Communication Checklist (2-COM) is a communication tool developed by van Os et al. (2002). It aims to provide an opportunity for patients to voice their needs and problem to minimize the discrepancy and miscommunication between patient and professional carer. Read more about this study
- Who is it for?
- Ages 15 to 64 years
- Conditions the study is for
- Schizophrenia, Communication
- What is being tested?
- The Two-Way Communication Checklist and Treatment as usual
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 1 siteHong Kong
- Study dates
- May 2015to Aug 2015
- 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 15 to 64 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients will be included if they meet the following criteria:
- attended the EASY service;
- were diagnosed with schizophrenia ,schizoaffective disorder or schizophreniform disorder according to ICD-10;
- were age between 15-64;
- were able to complete the informed consent.
Who cannot join
- Patients will be excluded if they meet the following criteria:
- had history of substance misuse;
- had history of intellectual disability;
- were non- Chinese speaking patients
- had violent risk
- had suicidal risk
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Two-Way Communication Checklist (2-COM) in First Episode Psychosis Patients in Hong Kong: an Open Label Randomized Controlled Trial
The Two-Way Communication Checklist (2-COM) is a communication tool developed by van Os et al. (2002). It aims to provide an opportunity for patients to voice their needs and problem to minimize the discrepancy and miscommunication between patient and professional carer. In this randomized controlled trial, the investigators aim to examine whether using 2-COM checklist would lead to improvement in first episode psychosis patient's overall satisfaction, change in treatment option in clinicians and consultation time.
Read the detailed description
Communication is at the heart of psychiatric practice. Good communication has positive impact on treatment, treatment satisfaction and treatment adherence. However, different characteristics of psychosis barricade the communication between clinicians and patients. Consequently, the divergent views of needs of care between patients and clinicians may be established due to miscommunication. Such divergence may barricade the planning and the outcome of treatment.
In Hong Kong, the core psychiatric services as well as early intervention for first episode psychosis patients are provided by psychiatric outpatient clinics. Mental health services in Hong Kong are overwhelmed by large demands of the services and inadequate mental health care workforce such as low psychiatrists-to-population ratio and psychiatric nurse-to-population ratio. The large demands of services and inadequate mental health care workforce restrained the services' quality. In some busy psychiatric outpatient clinic, a clinician needs to consult 30 patients in a 3-hour session. Hui et al. (2008) study showed that the mean consultation time in one of the general psychiatric outpatient clinic in Hong Kong is 5.8 minutes.
To sum up, a cost-effectiveness instrument is in need for the early intervention psychiatric outpatient clinic in Hong Kong. The instrument has to reduce the needs' divergence, communication between clinicians and patients, and enhance the patients' involvement of clinical decision-making in the rushed psychiatric consultation. The Two-Way Communication Checklist (2-COM) may satisfy the demand.
- Conditions
- Schizophrenia, Communication
- Being tested
- The Two-Way Communication Checklist, Treatment as usual
- Keywords
- 2-COM
- Medical subject headings
- Schizophrenia, Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Two-Way Communication ChecklistOther
Also called 2-COM
The Two-Way Communication Checklist (2-COM) is a communication tool developed by Van Os et al. (2002). It aims to provide an opportunity for patients to voice their needs and problem to minimize the discrepancy and miscommunication between patient and professional carer. 2-COM questionnaire was designed to give patients while they are waiting for consultation. Patients can either tick yes or no in the questionnaire to decide which the perceived problems are and which needs they want to discuss with the clinician. During the consultation, the ticked items would be discussed.
Treatment as usualOther
Also called TAU
Patients will attend a psychiatric consultation as usual.
| Study group | Role | What they receive |
|---|---|---|
| 2-COM group | Active comparator | Patients will use the Two-Way Communication Checklist (2-COM) once in a psychiatric consultation. Receives: Other: The Two-Way Communication Checklist |
| TAU group | Placebo comparator | Treatment as usual (TAU) group. Receives: Other: Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Satisfaction level (patient satisfaction questionnaire)
A patient satisfaction questionnaire as used in Hui et al. (2008) was adopted in this study. This was a self-administered questionnaire rated on a 5-point Likert scale (1 = very satisfactory to 5 = very unsatisfactory). The questionnaire consisted of 2 parts. Part A has 6 items concerning the perceived attitude of the clinician (subscale score range, 6-30). Part B has 11 items concerning communication with the clinician (subscale score range, 11-55). The higher score indicates the higher satisfaction.
Measured: within 30 minutes after a psychiatric consultation
Secondary outcomes (2)
Change of treatment (checklist)
A checklist that measured change in treatment was adopted. This checklist included 4 items which will be rated on a dichotomous selection (yes/no) by clinician. The 4 items are related to the change of medication, providing information about treatment, involvement of other members of the care team and professional support services.
Measured: within 30 minutes after a psychiatric consultation
Consultation time
The consultation time will be counted between patients' entering and leaving the consultation room by a stopwatch.
Measured: From the time of patients' entering the consultation room till leaving the consultation room in a psychiatric consultation, up to 5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2015 (estimated)
- Study startMay 2015
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chau Wing Leong, The University of Hong Kong
- Investigators
- Wing Leong Chau, RN(Psy), Principal investigator, Kwai Chung Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02435784
- Sponsor's protocol ID
- UW 15-170
- Status last verified
- Sep 2015
- First submitted
- 22 Apr 2015
- Last updated
- 22 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lam MM, Pearson V, Ng RM, Chiu CP, Law CW, Chen EY. What does recovery from psychosis mean? Perceptions of young first-episode patients. Int J Soc Psychiatry. 2011 Nov;57(6):580-7. doi: 10.1177/0020764010374418. Epub 2010 Jul 5.
PubMed 20603266Hui, C. L. M., Wong, G. H. Y., Lam, C. Y. K., Chow, P. P. L. & Chen, E. Y. H. (2008). Patients-clinician communication and needs identification for outpatients with schizophrenia in Hong Kong: role of the 2-COM instrument. Hong Kong Journal of Psychiatry, 18(2), 69-74.
Chan KK, Mak WW. The mediating role of self-stigma and unmet needs on the recovery of people with schizophrenia living in the community. Qual Life Res. 2014 Nov;23(9):2559-68. doi: 10.1007/s11136-014-0695-7. Epub 2014 Apr 23.
PubMed 24756436Wong GH, Hui CL, Wong DY, Tang JY, Chang WC, Chan SK, Lee EH, Xu JQ, Lin JJ, Lai DC, Tam W, Kok J, Chung DW, Hung SF, Chen EY. Developments in early intervention for psychosis in Hong Kong. East Asian Arch Psychiatry. 2012 Sep;22(3):100-4.
PubMed 23019282
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Two-Way Communication Checklist (2-COM) in First Episode Psychosis Patients in Hong Kong: an Open Label Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02435784
- Acronym / sponsor ID
- UW 15-170
- Conditions
- Schizophrenia, Communication
- Keywords
- 2-COM
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 6 May 2015 (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.
The Two-Way Communication Checklist (2-COM) is a communication tool developed by van Os et al. (2002). It aims to provide an opportunity for patients to voice their needs and problem to minimize the discrepancy and miscommunication between patient and professional carer. In this randomized controlled trial, the investigators aim to examine whether using 2-COM checklist would lead to improvement in first episode psychosis patient's overall satisfaction, change in treatment option in clinicians and consultation time.
Detailed description
Communication is at the heart of psychiatric practice. Good communication has positive impact on treatment, treatment satisfaction and treatment adherence. However, different characteristics of psychosis barricade the communication between clinicians and patients. Consequently, the divergent views of needs of care between patients and clinicians may be established due to miscommunication. Such divergence may barricade the planning and the outcome of treatment.
In Hong Kong, the core psychiatric services as well as early intervention for first episode psychosis patients are provided by psychiatric outpatient clinics. Mental health services in Hong Kong are overwhelmed by large demands of the services and inadequate mental health care workforce such as low psychiatrists-to-population ratio and psychiatric nurse-to-population ratio. The large demands of services and inadequate mental health care workforce restrained the services' quality. In some busy psychiatric outpatient clinic, a clinician needs to consult 30 patients in a 3-hour session. Hui et al. (2008) study showed that the mean consultation time in one of the general psychiatric outpatient clinic in Hong Kong is 5.8 minutes.
To sum up, a cost-effectiveness instrument is in need for the early intervention psychiatric outpatient clinic in Hong Kong. The instrument has to reduce the needs' divergence, communication between clinicians and patients, and enhance the patients' involvement of clinical decision-making in the rushed psychiatric consultation. The Two-Way Communication Checklist (2-COM) may satisfy the demand.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2-COM group | Active comparator | Other: The Two-Way Communication ChecklistPatients will use the Two-Way Communication Checklist (2-COM) once in a psychiatric consultation. |
| TAU group | Placebo comparator | Other: Treatment as usualTreatment as usual (TAU) group. |
Who may qualify
- Ages
- 15 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- attended the EASY service;
- were diagnosed with schizophrenia ,schizoaffective disorder or schizophreniform disorder according to ICD-10;
- were age between 15-64;
- were able to complete the informed consent.
Key exclusion criteria (6 listed)
- had history of substance misuse;
- had history of intellectual disability;
- were non- Chinese speaking patients
- had violent risk
- had suicidal risk
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 |
|---|---|---|
| The Two-Way Communication ChecklistAlso: 2-COMThe Two-Way Communication Checklist (2-COM) is a communication tool developed by Van Os et al. (2002). It aims to provide an opportunity for patients to voice their needs and problem to minimize the discrepancy and miscommunication between patient and professional carer. 2-COM questionnaire was designed to give patients while they are waiting for consultation. Patients can either tick yes or no in the questionnaire to decide which the perceived problems are and which needs they want to discuss with the clinician. During the consultation, the ticked items would be discussed. | Other | 2-COM group |
| Treatment as usualAlso: TAUPatients will attend a psychiatric consultation as usual. | Other | TAU group |
Primary outcome
Satisfaction level (patient satisfaction questionnaire)
Time frame: within 30 minutes after a psychiatric consultation
A patient satisfaction questionnaire as used in Hui et al. (2008) was adopted in this study. This was a self-administered questionnaire rated on a 5-point Likert scale (1 = very satisfactory to 5 = very unsatisfactory). The questionnaire consisted of 2 parts. Part A has 6 items concerning the perceived attitude of the clinician (subscale score range, 6-30). Part B has 11 items concerning communication with the clinician (subscale score range, 11-55). The higher score indicates the higher satisfaction.
2 secondary outcomes
Change of treatment (checklist)
Time frame: within 30 minutes after a psychiatric consultation
Consultation time
Time frame: From the time of patients' entering the consultation room till leaving the consultation room in a psychiatric consultation, up to 5 hours
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 22 Sep 2015.
- Background: PubMed 20603266Lam MM, Pearson V, Ng RM, Chiu CP, Law CW, Chen EY. What does recovery from psychosis mean? Perceptions of young first-episode patients. Int J Soc Psychiatry. 2011 Nov;57(6):580-7. doi: 10.1177/0020764010374418. Epub 2010 Jul 5.
- BackgroundHui, C. L. M., Wong, G. H. Y., Lam, C. Y. K., Chow, P. P. L. & Chen, E. Y. H. (2008). Patients-clinician communication and needs identification for outpatients with schizophrenia in Hong Kong: role of the 2-COM instrument. Hong Kong Journal of Psychiatry, 18(2), 69-74.
- Background: PubMed 24756436Chan KK, Mak WW. The mediating role of self-stigma and unmet needs on the recovery of people with schizophrenia living in the community. Qual Life Res. 2014 Nov;23(9):2559-68. doi: 10.1007/s11136-014-0695-7. Epub 2014 Apr 23.
- Background: PubMed 23019282Wong GH, Hui CL, Wong DY, Tang JY, Chang WC, Chan SK, Lee EH, Xu JQ, Lin JJ, Lai DC, Tam W, Kok J, Chung DW, Hung SF, Chen EY. Developments in early intervention for psychosis in Hong Kong. East Asian Arch Psychiatry. 2012 Sep;22(3):100-4.
- Previous 2-COM studiesLink provided by the sponsor.
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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.
Wing Leong Chau, RN(Psy) principal investigator
Kwai Chung Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Two-Way Communication Checklist and Treatment as usual in people with Schizophrenia and Communication, run by The University of Hong Kong at 1 site in Hong Kong.
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 5 inclusion and 6 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 22 Sep 2015. 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 Hong Kong. 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. Some participants in this study may receive a placebo. 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?
Satisfaction level (patient satisfaction questionnaire) (time frame: within 30 minutes after a psychiatric consultation). 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 NCT02435784, which also lists 4 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 22 Sep 2015.