Using standardized patients to measure quality of care in public and private optical health facilities across China

ISRCTN	ISRCTN17998847
DOI	https://doi.org/10.1186/ISRCTN17998847
Secondary identifying numbers	25904

Submission date: 13/09/2016
Registration date: 30/09/2016
Last edited: 28/09/2016

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Eye Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

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

Contact information

Mr Matthew Boswell
Public

Rural Education Action Program
Encina Hall, E-407
616 Serra Street
Stanford
94305
United States of America

Study information

Study design	Observational cross sectional study
Primary study design	Observational
Secondary study design	Cross sectional study
Study setting(s)	Other
Study type	Other
Participant information sheet	No participant information sheet available
Scientific title	Using standardized patients to measure quality of care in public and private optical health facilities across China
Study objectives	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(s)	Stanford University IRB, ref: 25904
Health condition(s) or problem(s) studied	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
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 study start date	30/09/2016
Completion date	15/10/2016

Eligibility

Participant type(s)	Mixed
Age group	Adult
Sex	Both
Target number of participants	420
Key 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
Key exclusion criteria	Participants not fulfilling the inclusion criteria
Date of first enrolment	30/09/2016
Date of final enrolment	02/10/2016

Locations

Countries of recruitment

China

Study participating centre

Number of public and private optic clinics in China

-
China

Sponsor information

Rural Education Action Program at Stanford University
University/education

Encina Hall, E-407
616 Serra Street
Stanford, CA 94305-6055
Stanford
94305-6055
United States of America

Phone	N/A
Email	yang2jin@stanford.edu
Website	http://reap.fsi.stanford.edu/
"ROR"	https://ror.org/00f54p054

Funders

Funder type

University/education

Stanford University

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
Publication and dissemination plan
IPD sharing plan