- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Hong Kong, Hong Kong
- EASY Clinic, Queen Mary Hospital
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Aktiv komparator: 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.
Andre navn:
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Placebo komparator: TAU group
Treatment as usual (TAU) group.
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Patients will attend a psychiatric consultation as usual.
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Satisfaction level (patient satisfaction questionnaire)
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Change of treatment (checklist)
Tidsramme: 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
Tidsramme: 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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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Wing Leong Chau, RN(Psy), Kwai Chung Hospital, Hong Kong
Publikasjoner og nyttige lenker
Generelle publikasjoner
- 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.
Hjelpsomme linker
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- UW 15-170
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