Plain English Summary
Background and study aims
Previous research has revealed that rural China is currently experiencing a vision (eye) care crisis. According to estimates, 215 million individuals in rural China aged 5 years and above suffer from poor vision. Furthermore, it has been found that virtually no village clinics offer optometric services and only one in five township health centers do. However, due to lack of research and objective measures for quality of care, it is difficult to work out how to best meet the vision care needs of rural China.The purpose of this study is two-fold: first, to assess quality of optical care services across public and private optical facilities in China and, second, to identify existing barriers to optical care. In order to assess the quality of optical care services, this study will include what is referred to as a standardized patient module, in which trained student actors will pose as regular patients seeking optical care at local optical facilities. Due to the nature of the study, the staff will not be informed of the standardized patient visits.
Who can participate?
Student actors posing as patients. All are Shaanxi Normal University graduate students between the ages of 22 and 30 years old.
What does the study involve?
Each student actor is trained to pretend to have blurry vision and wrong prescription glasses. Each also present themselves as a poor individual at some times and a wealthy individual at others (e.g., by altering clothes, accent, indicating budget, etc.). All actors present themselves at two public vision centres and four private vision shops and say that they are seeking a second opinion. All patient student actors record information related to any optical vision examinations they have done and their and results, their treatment by the optical staff, facility equipment, and cost of services offered.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
A number of public and private optic clinics in China.
When is the study starting and how long is it expected to run for?
September 2016 to October 2016
Who is funding the study?
Stanford University (USA)
Who is the main contact?
Mr Matthew Boswell
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
25904
Study information
Scientific title
Using standardized patients to measure quality of care in public and private optical health facilities across China
Acronym
Study hypothesis
The primary aim of this study is to identify the quality of optic care across public and private optical facilities in China. The standardized patients will record information on diagnosis quality, optical staff treatment, facility equipment, and cost of services. Additionally, the acquired information will identify potential barriers to receiving vision care.
Ethics approval
Stanford University IRB, ref: 25904
Study design
Observational cross sectional study
Primary study design
Observational
Secondary study design
Cross sectional study
Trial setting
Other
Trial type
Other
Patient information sheet
No participant information sheet available
Condition
Quality of vision care in China
Intervention
In this study, 60 trained student actors will serve as standardized patients at private optical clinics and public vision centers in China. Each student actor will be trained to feign blurry vision and wrong prescription glasses, each student actor will indicate a wealthy appearance and a poor appearance (e.g., by altering clothes, accent, indicating budget, etc.), each will be trained to say they are seeking a second opinion. All standardized patient student actors will visit two public vision centers and four private vision shops within or near their hometown.
Due to the nature of the study, the optical facility staff will not be informed of the standardized patient visits. As the standardized patient actors will be visiting between 300 and 360 private and public optical centers, it is not feasible and would significantly influence the research findings if each optical facility were informed of the upcoming standardized patient visit.
This study is cross-sectional (researchers will not follow up with the optic care facilities). As for timing, the preparation for the standardized patients and the actual testing will take 1-2 months. Visits by the standardized patients will take around 40 days. Data cleaning and analysis will take approximately 4 months.
Intervention type
Other
Phase
Drug names
Primary outcome measure
1. Quality of delivered optical care as measured by:
1.1 Correct refraction procedure observed by standardized patient during visit
1.2. Correct prescription attained during visit
1.3. Whether eye glasses match prescription at the time eye glasses are obtained
Secondary outcome measures
1. Cost of exam paid by standardized patient during visit
2. Cost of eyeglasses paid by standardized patient during visit
Overall trial start date
30/09/2016
Overall trial end date
15/10/2016
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Optical facility staff:
1. Working in an optical facility
3. Split between rural and urban parts of China
4. Adults
Student actors:
5. Graduate students at Shaanxi Normal University
6. Between 22 and 30 years old
Participant type
Mixed
Age group
Adult
Gender
Both
Target number of participants
420
Participant exclusion criteria
Participants not fulfilling the inclusion criteria
Recruitment start date
30/09/2016
Recruitment end date
02/10/2016
Locations
Countries of recruitment
China
Trial participating centre
Number of public and private optic clinics in China
-
China
Sponsor information
Organisation
Rural Education Action Program at Stanford University
Sponsor details
Encina Hall
E-407
616 Serra Street
Stanford
CA 94305-6055
Stanford
94305-6055
United States of America
N/A
yang2jin@stanford.edu
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
Stanford University
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Intention to publish date
Participant level data
Available on request
Basic results (scientific)
Publication list