- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT02435784
The Two-Way Communication Checklist (2-COM) in First Episode Psychosis Patients in Hong Kong
The Two-Way Communication Checklist (2-COM) in First Episode Psychosis Patients in Hong Kong: an Open Label Randomized Controlled Trial
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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Hong Kong, Hongkong
- EASY Clinic, Queen Mary Hospital
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
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.
Exclusion Criteria:
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Podpůrná péče
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Aktivní komparátor: 2-COM group
Patients will use the Two-Way Communication Checklist (2-COM) once in a psychiatric consultation.
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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.
Ostatní jména:
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Komparátor placeba: TAU group
Treatment as usual (TAU) group.
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Patients will attend a psychiatric consultation as usual.
Ostatní jména:
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Satisfaction level (patient satisfaction questionnaire)
Časové okno: within 30 minutes after a psychiatric consultation
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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.
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within 30 minutes after a psychiatric consultation
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Change of treatment (checklist)
Časové okno: within 30 minutes after a psychiatric consultation
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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.
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within 30 minutes after a psychiatric consultation
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Consultation time
Časové okno: From the time of patients' entering the consultation room till leaving the consultation room in a psychiatric consultation, up to 5 hours
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The consultation time will be counted between patients' entering and leaving the consultation room by a stopwatch.
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From the time of patients' entering the consultation room till leaving the consultation room in a psychiatric consultation, up to 5 hours
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Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Wing Leong Chau, RN(Psy), Kwai Chung Hospital, Hong Kong
Publikace a užitečné odkazy
Obecné publikace
- 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.
- Hui, 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.
- Wong 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.
Užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- UW 15-170
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Klinické studie na The Two-Way Communication Checklist
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