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The Two-Way Communication Checklist (2-COM) in First Episode Psychosis Patients in Hong Kong

Primary Purpose

Schizophrenia, Communication

Status
Completed
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
The Two-Way Communication Checklist
Treatment as usual
Sponsored by
The University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Schizophrenia focused on measuring 2-COM

Eligibility Criteria

15 Years - 64 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • EASY Clinic, Queen Mary Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

2-COM group

TAU group

Arm Description

Patients will use the Two-Way Communication Checklist (2-COM) once in a psychiatric consultation.

Treatment as usual (TAU) group.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Consultation time
The consultation time will be counted between patients' entering and leaving the consultation room by a stopwatch.

Full Information

First Posted
April 22, 2015
Last Updated
September 21, 2015
Sponsor
The University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT02435784
Brief Title
The Two-Way Communication Checklist (2-COM) in First Episode Psychosis Patients in Hong Kong
Official Title
The Two-Way Communication Checklist (2-COM) in First Episode Psychosis Patients in Hong Kong: an Open Label Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
May 2015 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Hong Kong

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Communication
Keywords
2-COM

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
84 (Actual)

8. Arms, Groups, and Interventions

Arm Title
2-COM group
Arm Type
Active Comparator
Arm Description
Patients will use the Two-Way Communication Checklist (2-COM) once in a psychiatric consultation.
Arm Title
TAU group
Arm Type
Placebo Comparator
Arm Description
Treatment as usual (TAU) group.
Intervention Type
Other
Intervention Name(s)
The Two-Way Communication Checklist
Other Intervention Name(s)
2-COM
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Treatment as usual
Other Intervention Name(s)
TAU
Intervention Description
Patients will attend a psychiatric consultation as usual.
Primary Outcome Measure Information:
Title
Satisfaction level (patient satisfaction questionnaire)
Description
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.
Time Frame
within 30 minutes after a psychiatric consultation
Secondary Outcome Measure Information:
Title
Change of treatment (checklist)
Description
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.
Time Frame
within 30 minutes after a psychiatric consultation
Title
Consultation time
Description
The consultation time will be counted between patients' entering and leaving the consultation room by a stopwatch.
Time Frame
From the time of patients' entering the consultation room till leaving the consultation room in a psychiatric consultation, up to 5 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wing Leong Chau, RN(Psy)
Organizational Affiliation
Kwai Chung Hospital, Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
EASY Clinic, Queen Mary Hospital
City
Hong Kong
Country
Hong Kong

12. IPD Sharing Statement

Citations:
PubMed Identifier
20603266
Citation
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.
Results Reference
background
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.
Results Reference
background
PubMed Identifier
24756436
Citation
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.
Results Reference
background
PubMed Identifier
23019282
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.
Results Reference
background
Links:
URL
http://2coms.homestead.com/
Description
Previous 2-COM studies

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The Two-Way Communication Checklist (2-COM) in First Episode Psychosis Patients in Hong Kong

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