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Impact of a Printed Decision Aid on Cataract Surgery Choice

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03525015
Recruitment Status : Unknown
Verified December 2018 by Yingfeng Zheng, Sun Yat-sen University.
Recruitment status was:  Recruiting
First Posted : May 15, 2018
Last Update Posted : December 26, 2018
Sponsor:
Information provided by (Responsible Party):
Yingfeng Zheng, Sun Yat-sen University

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Age Related Cataracts Other: A decision aid booklet about cataract surgery choice Other: An usual booklet about cataract and cataract surgery Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 696 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Impact of a Printed Decision Aid on Cataract Surgery Choice: A Multi-center Randomized Controlled Trial
Actual Study Start Date : May 16, 2018
Actual Primary Completion Date : October 30, 2018
Estimated Study Completion Date : October 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Informed choice about cataract surgery [ Time Frame: 2 weeks ]
    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).


Secondary Outcome Measures :
  1. Perceived importance of cataract surgery benefit/harms [ Time Frame: 2 weeks ]
    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. Perceived personal chances of surgical benefit/harms [ Time Frame: 2 weeks ]
    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).

  3. Decisional conflict [ Time Frame: 2 weeks ]
    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.

  4. Decisional confidence [ Time Frame: 2 weeks ]
    Decisional confidence will be assessed using a 11-item Decision Self Efficacy Scale.

  5. Time perspective [ Time Frame: 2 weeks ]
    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.

  6. Anticipated regret [ Time Frame: 2 weeks ]
    Two items from a validated scale will measure anticipated regret about having cataract surgery (action regret) and about not having cataract (inaction regret).

  7. Cataract worry and anxiety [ Time Frame: 2 weeks ]
    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.

  8. Booklet utilization and acceptability [ Time Frame: 2 weeks ]
    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.

  9. Undergoing cataract surgery [ Time Frame: 1 year ]
    Self-reported undergoing cataract surgery will be assessed via telephone survey at 1 year.

  10. Decision regret [ Time Frame: 1 year ]
    The Decision Regret Scale will measure participants' level of regret regarding their initial decision whether to have cataract surgery or not.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03525015


Contacts
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Contact: Yingfeng Zheng, M.D. Ph.D. +8613922286455 zhyfeng@mail.sysu.edu.cn

Locations
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China
Dashi Community Health Center Recruiting
Guangzhou, China
Contact: Yurong Hu         
Donghuan Community Health Center Recruiting
Guangzhou, China
Contact: Qiuling Xia         
Huangcun Community Health Center Recruiting
Guangzhou, China
Contact: Shaochun Wang         
Huaying Community Health Center Recruiting
Guangzhou, China
Contact: Haifeng Wang         
Qiaonan Community Health Center Recruiting
Guangzhou, China
Contact: Weijian Chen         
Shawan Community Health Center Recruiting
Guangzhou, China
Contact: Yu Wong         
Shibi Community Health Center Recruiting
Guangzhou, China
Contact: Feiming Fan         
Shiqiao Community Health Center Recruiting
Guangzhou, China
Contact: Zhenhong Chen         
Xiayuan Community Health Center Recruiting
Guangzhou, China
Contact: Jiang Tan         
Yuancun Community Health Center Recruiting
Guangzhou, China
Contact: Baoli Liu         
Zhognshan Ophthalmic Center, Sun Yat-sen University Recruiting
Guangzhou, China
Contact: Yizhi Liu         
Sponsors and Collaborators
Sun Yat-sen University
Investigators
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Study Director: Yingfeng Zheng, M.D. Ph.D. Zhongshan Ophthalmic Center, Sun Yat-sen Univeristy
More Information
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Responsible Party: Yingfeng Zheng, Clinical investigator, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT03525015    
Other Study ID Numbers: 2017KYPJ066
First Posted: May 15, 2018    Key Record Dates
Last Update Posted: December 26, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cataract
Lens Diseases
Eye Diseases