Guangdong Uptake of Surgery Trial (GUSTO)

The Effect of Counseling in Cataract Screening: Guangdong Uptake of Surgery Trial

The purpose of this study is:

1. To determine whether an educational intervention designed based on studies in the area is effective in increasing acceptance of surgery and presentation to the hospital, when adjusting for a number of potential determinants of service uptake;
2. To assess short-term impact of the educational intervention on knowledge about cataract and attitudes toward locally-available surgical services.

Study Overview

• Status: Completed
• Conditions: Cataract
• Intervention / Treatment: Behavioral: Video and counseling for cataract patients

Detailed Description

China is home to the 18% of the world's blind people, an estimated 6.6 million. In China, cataract is the leading cause of blindness. In Guangdong, current counseling measures for patients diagnosed with cataract are minimal and often lack adequate descriptions of what cataract is, what causes cataract, and benefits/risks of surgery. A counseling session for cataract patients and family members, conducted by a trained nurse during outreach screening, may increase subsequent attendance at pre-operative examination, acceptance of cataract surgery, and attendance at follow-up examinations. An integral part of this counseling is a short movie consisting of testimony from a former cataract patient who underwent surgery ("pseudophakic motivator"). The use of pseudophakic motivators have been shown to be effective in increasing surgical uptake. In addition, a previously validated "Barriers Questionnaire" will be used to assess predictors of of hospital attendance, surgery acceptance, and follow-up attendance in the categories of cost, transportation, knowledge, and concerns about quality.

• Study Type: Interventional
• Enrollment (Actual): 434
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China
      • Zhongshan Ophthalmic Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• thought by the examiner to have age-related or myopic cataract in one or both eyes
• pinhole-corrected visual acuity less than or equal to 6/18.

Exclusion Criteria:

• traumatic cataract
• inability to give informed consent due to dementia or other reasons.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Counseling; Subjects will be asked to watch a 5-10 min video and participate in a 10-15 min pre-operative counseling session with a trained nurse. Subjects will also participate in a 5 min post-operative counseling session.	Behavioral: Video and counseling for cataract patients; Intervention includes: (1) a 5-10 min video consisting of testimony from a previous cataract patient and a doctor; (2) a 10-15 min pre-operative counseling session with a trained nurse, and (3) a 5 min post-operative counseling session with a trained nurse.
No Intervention: Non-counseling

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Decision to Undergo Cataract Surgery (Surgery Acceptance)	Measured as a percentage of subjects who decide to undergo cataract surgery within 6 months after screening (positive) out of total subjects.	within 6 months after screening examination

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Attendance at Hospital for Pre-operative Examination	Measured as a percentage of people who presented to the hospital within 6 months after screening (positive) out of total subjects.	within 6 months after screening examination
Knowledge That Cataract Can be Treated	Measured as a percentage of subjects who correctly answer the question in a questionnaire.	Assessed during day of screening examination
Belief That Surgery Will be Painful	Measured as a percentage of subjects who agree with the statement in a questionnaire.	Assessed during day of screening examination
Belief That Vision Will Improve "a Lot" Following Surgery	Measured as a percentage of subjects who agree with the statement in a questionnaire.	Assessed during day of screening examination
Belief That Surgeons at the Hospital Are "Highly Skilled"	Measured as a percentage of subjects who agree with the statement in a questionnaire.	Assessed during day of screening examination
Belief That Doctors and Nurses at the Hospital Have "Very Good" Attitudes	Measured as a percentage of subjects who agree with the statement in a questionnaire.	Assessed during day of screening examination

Collaborators and Investigators

• Sponsor: Sun Yat-sen University
• Collaborators: Helen Keller International; Swarthmore College
• Investigators: Principal Investigator: Nathan Congdon, MD, MPH, Zhongshan Ophthalmic Center, Sun Yat-sen University; Principal Investigator: Mingguang He, PHD, MPH, Zhongshan Ophthalmic Center, Sun Yat-sen University; Principal Investigator: David Friedman, MD, MPH, Johns Hopkins University

Publications and helpful links

General Publications

• Tan L. Increasing the volume of cataract surgery: an experience in rural China. Community Eye Health. 2006 Dec;19(60):61-3. No abstract available.
• Ellwein LB, Lepkowski JM, Thulasiraj RD, Brilliant GE. The cost effectiveness of strategies to reduce barriers to cataract surgery. The Operations Research Group. Int Ophthalmol. 1991 May;15(3):175-83. doi: 10.1007/BF00153924.
• Liu T, Congdon N, Yan X, Jin L, Wu Y, Friedman D, He M. A randomized, controlled trial of an intervention promoting cataract surgery acceptance in rural China: the Guangzhou Uptake of Surgery Trial (GUSTO). Invest Ophthalmol Vis Sci. 2012 Aug 13;53(9):5271-8. doi: 10.1167/iovs.12-9798.
• Barry MP, Dagnelie G; Argus II Study Group. Use of the Argus II retinal prosthesis to improve visual guidance of fine hand movements. Invest Ophthalmol Vis Sci. 2012 Aug 1;53(9):5095-101. doi: 10.1167/iovs.12-9536.

Study record dates

Study Major Dates

• Study Start: July 1, 2010
• Primary Completion (Actual): June 1, 2011
• Study Completion (Actual): June 1, 2011

Study Registration Dates

• First Submitted: May 12, 2010
• First Submitted That Met QC Criteria: May 13, 2010
• First Posted (Estimate): May 14, 2010

Study Record Updates

• Last Update Posted (Estimate): February 3, 2012
• Last Update Submitted That Met QC Criteria: February 1, 2012
• Last Verified: February 1, 2012

More Information

Terms related to this study

• Keywords: counseling; follow-up; cataract; surgical uptake
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: ZOC-123