Impact of a Printed Decision Aid on Cataract Surgery Choice

Impact of a Printed Decision Aid on Cataract Surgery Choice: A Multi-center Randomized Controlled Trial

The purpose of the study is to explore whether a decision aid booklet is more effective than the usual booklet for patients to make an informed choice on cataract surgery.

Study Overview

• Status: Unknown
• Conditions: Age Related Cataracts
• Intervention / Treatment: Other: A decision aid booklet about cataract surgery choice; Other: An usual booklet about cataract and cataract surgery

Detailed Description

Shared decision making is increasingly recommended to facilitate quality care, but there is a lack of cataract surgery decision aid in clinical practice. The aim of this study is to evaluate the effectiveness of a cataract surgery decision aid for cataract patients with different levels of health literacy.

We will conduct a randomized controlled trial for cataract patients aged 50-80 years. We will randomly assign participants to either the intervention using a decision aid booklet or the one using a usual cataract booklet. The primary outcome is informed choice (defined as adequate knowledge and consistency between attitudes and intentions) 2 weeks after intervention.

• Study Type: Interventional
• Enrollment (Anticipated): 696
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangzhou, China
    • Recruiting
    • Zhognshan Ophthalmic Center, Sun Yat-sen University
    • Contact: Yizhi Liu
  • Guangzhou, China
    • Recruiting
    • Dashi Community Health Center
    • Contact: Yurong Hu
  • Guangzhou, China
    • Recruiting
    • Donghuan Community Health Center
    • Contact: Qiuling Xia
  • Guangzhou, China
    • Recruiting
    • Huangcun Community Health Center
    • Contact: Shaochun Wang
  • Guangzhou, China
    • Recruiting
    • Huaying Community Health Center
    • Contact: Haifeng Wang
  • Guangzhou, China
    • Recruiting
    • Qiaonan Community Health Center
    • Contact: Weijian Chen
  • Guangzhou, China
    • Recruiting
    • Shawan Community Health Center
    • Contact: Yu Wong
  • Guangzhou, China
    • Recruiting
    • Shibi Community Health Center
    • Contact: Feiming Fan
  • Guangzhou, China
    • Recruiting
    • Shiqiao Community Health Center
    • Contact: Zhenhong Chen
  • Guangzhou, China
    • Recruiting
    • Xiayuan Community Health Center
    • Contact: Jiang Tan
  • Guangzhou, China
    • Recruiting
    • Yuancun Community Health Center
    • Contact: Baoli Liu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Definite diagnosis of age-related cataract;
2. The best corrected visual acuity (BCVA) is above 20/60;
3. Cataract opacity meets any of the following criterion based on lens opacity classification system (LOCS) III: nuclear color and nuclear opalescence is greater than or equal to grade 2 (NO2/NC2); cortical opacity is greater than or equal to grade 2 (C2); posterior subcapsular opacity is greater than or equal to grade 2 (P2);
4. Willing to know about cataract and cataract surgery;
5. Being able to afford cataract surgery;
6. Willing to participate in the study and provide the informed content.

Exclusion Criteria:

1. Having received cataract surgery;
2. Having hearing disorders;
3. Having mental disorders;
4. Having ocular disorders other than cataract;
5. Having surgery contraindication;
6. Unwilling to participate in this study.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: A decision aid booklet; A decision aid booklet about cataract surgery choice	Other: A decision aid booklet about cataract surgery choice; Potential participants receive a decision aid booklet with information about cataract surgery choice, and outcome data will be gathered using standardized questions in a structured interview after 2 weeks and 1 year.
Active Comparator: An usual booklet; An usual booklet about cataract and cataract surgery	Other: An usual booklet about cataract and cataract surgery; Potential participants receive an usual booklet with information about cataract and cataract surgery, and outcome data will be gathered using standardized questions in a structured interview after 2 weeks and 1 year.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Informed choice about cataract surgery	Informed choice is measured as the proportion of participants who make an informed choice about whether to receive cataract surgery as soon as possible or not. For the individual, making an informed choice is defined as (i) having adequate knowledge and (ii) expressing intentions that are consistent with （iii）one's attitudes. Knowledge will be measured by assessing participants' understanding of the numerical and conceptual information in the booklets, using items modified from previous screening decision aid trials (Hersch 2015). Attitudes towards cataract surgery will be assessed using a theory-based generic screening attitudes scale (Dormandy 2006). A single item will measure intentions about having cataract surgery as soon as possible (or not), using a set of 5 response options (Gwyn 2003; Watson 2006).	2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perceived importance of cataract surgery benefit/harms	Purpose-developed items will be used to ask participants about their personal perceptions of the importance of specific outcomes in their decision-making about cataract surgery. Participants will be asked how important it is to (i) have significant increase in vision-related quality of life, and (ii) have no significant increase in vision-related quality of life after receiving cataract surgery as soon as possible. The four response options range from very important to not at all important (Hersch 2014).	2 weeks
Perceived personal chances of surgical benefit/harms	Participants will be asked about their perceived personal likelihood of experiencing specific outcomes if they have cataract surgery as soon as possible, compared with an average patient who had undergone cataract surgery, using five response categories ranging from much lower to much higher (Longman 2012).	2 weeks
Decisional conflict	Decisional conflict will be measured using a scale named Decisional Conflict Scale. The scale is made of 16 items, using five response scores ranging from 0 to 4. The lower values represent a better outcome.	2 weeks
Decisional confidence	Decisional confidence will be assessed using a 11-item Decision Self Efficacy Scale.	2 weeks
Time perspective	This will be assessed using a 4-item short form of the Consideration of Future Consequences Scale, with five response categories ranging from strongly agree to strongly disagree.	2 weeks
Anticipated regret	Two items from a validated scale will measure anticipated regret about having cataract surgery (action regret) and about not having cataract (inaction regret).	2 weeks
Cataract worry and anxiety	A validated single item will measure participants' level of worry about progression of cataract , using four verbal response categories ranging from not worried at all to very worried. Anxiety will be measured with a six-item short form.	2 weeks
Booklet utilization and acceptability	We examined the utilization and acceptability of the decision aid using closed and open ended questions. Perceptions of the decision aid, in terms of its length, clarity, balance and usefulness in decision making were elicited using a modified scale (Mathieu 2010) (Smith 2009). We also asked participants to comment on their design preferences towards the booklets.	2 weeks
Undergoing cataract surgery	Self-reported undergoing cataract surgery will be assessed via telephone survey at 1 year.	1 year
Decision regret	The Decision Regret Scale will measure participants' level of regret regarding their initial decision whether to have cataract surgery or not.	1 year

Collaborators and Investigators

• Sponsor: Sun Yat-sen University
• Investigators: Study Director: Yingfeng Zheng, M.D. Ph.D., Zhongshan Ophthalmic Center, Sun Yat-sen Univeristy

Study record dates

Study Major Dates

• Study Start (Actual): May 16, 2018
• Primary Completion (Actual): October 30, 2018
• Study Completion (Anticipated): October 30, 2019

Study Registration Dates

• First Submitted: April 12, 2018
• First Submitted That Met QC Criteria: May 2, 2018
• First Posted (Actual): May 15, 2018

Study Record Updates

• Last Update Posted (Actual): December 26, 2018
• Last Update Submitted That Met QC Criteria: December 23, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: 2017KYPJ066

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No