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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02435784
Other study ID # UW 15-170
Secondary ID
Status Completed
Phase N/A
First received April 22, 2015
Last updated September 21, 2015
Start date May 2015
Est. completion date August 2015

Study information

Verified date September 2015
Source The University of Hong Kong
Contact n/a
Is FDA regulated No
Health authority Hong Kong: Ethics Committee
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 84
Est. completion date August 2015
Est. primary completion date August 2015
Accepts healthy volunteers No
Gender Both
Age group 15 Years to 64 Years
Eligibility Inclusion Criteria:

Patients will be included if they meet the following criteria:

1. attended the EASY service;

2. were diagnosed with schizophrenia ,schizoaffective disorder or schizophreniform disorder according to ICD-10;

3. were age between 15-64;

4. were able to complete the informed consent.

Exclusion Criteria:

Patients will be excluded if they meet the following criteria:

1. had history of substance misuse;

2. had history of intellectual disability;

3. were non- Chinese speaking patients

4. had violent risk

5. had suicidal risk

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care


Related Conditions & MeSH terms


Intervention

Other:
The Two-Way Communication Checklist
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 usual
Patients will attend a psychiatric consultation as usual.

Locations

Country Name City State
Hong Kong EASY Clinic, Queen Mary Hospital Hong Kong

Sponsors (1)

Lead Sponsor Collaborator
The University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

References & Publications (4)

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. — View Citation

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.

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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. within 30 minutes after a psychiatric consultation No
Secondary 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. within 30 minutes after a psychiatric consultation No
Secondary Consultation time The consultation time will be counted between patients' entering and leaving the consultation room by a stopwatch. From the time of patients' entering the consultation room till leaving the consultation room in a psychiatric consultation, up to 5 hours No
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