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Impact of a Printed Decision Aid on Cataract Surgery Choice

Primary Purpose

Age Related Cataracts

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
A decision aid booklet about cataract surgery choice
An usual booklet about cataract and cataract surgery
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Age Related Cataracts

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Dashi Community Health CenterRecruiting
  • Donghuan Community Health CenterRecruiting
  • Huangcun Community Health CenterRecruiting
  • Huaying Community Health CenterRecruiting
  • Qiaonan Community Health CenterRecruiting
  • Shawan Community Health CenterRecruiting
  • Shibi Community Health CenterRecruiting
  • Shiqiao Community Health CenterRecruiting
  • Xiayuan Community Health CenterRecruiting
  • Yuancun Community Health CenterRecruiting
  • Zhognshan Ophthalmic Center, Sun Yat-sen UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

A decision aid booklet

An usual booklet

Arm Description

A decision aid booklet about cataract surgery choice

An usual booklet about cataract and cataract surgery

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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).
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).
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.
Decisional confidence
Decisional confidence will be assessed using a 11-item Decision Self Efficacy Scale.
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.
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).
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.
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.
Undergoing cataract surgery
Self-reported undergoing cataract surgery will be assessed via telephone survey at 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.

Full Information

First Posted
April 12, 2018
Last Updated
December 23, 2018
Sponsor
Sun Yat-sen University
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1. Study Identification

Unique Protocol Identification Number
NCT03525015
Brief Title
Impact of a Printed Decision Aid on Cataract Surgery Choice
Official Title
Impact of a Printed Decision Aid on Cataract Surgery Choice: A Multi-center Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Unknown status
Study Start Date
May 16, 2018 (Actual)
Primary Completion Date
October 30, 2018 (Actual)
Study Completion Date
October 30, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Age Related Cataracts

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
696 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A decision aid booklet
Arm Type
Experimental
Arm Description
A decision aid booklet about cataract surgery choice
Arm Title
An usual booklet
Arm Type
Active Comparator
Arm Description
An usual booklet about cataract and cataract surgery
Intervention Type
Other
Intervention Name(s)
A decision aid booklet about cataract surgery choice
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
An usual booklet about cataract and cataract surgery
Intervention Description
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.
Primary Outcome Measure Information:
Title
Informed choice about cataract surgery
Description
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).
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Perceived importance of cataract surgery benefit/harms
Description
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).
Time Frame
2 weeks
Title
Perceived personal chances of surgical benefit/harms
Description
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).
Time Frame
2 weeks
Title
Decisional conflict
Description
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.
Time Frame
2 weeks
Title
Decisional confidence
Description
Decisional confidence will be assessed using a 11-item Decision Self Efficacy Scale.
Time Frame
2 weeks
Title
Time perspective
Description
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.
Time Frame
2 weeks
Title
Anticipated regret
Description
Two items from a validated scale will measure anticipated regret about having cataract surgery (action regret) and about not having cataract (inaction regret).
Time Frame
2 weeks
Title
Cataract worry and anxiety
Description
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.
Time Frame
2 weeks
Title
Booklet utilization and acceptability
Description
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.
Time Frame
2 weeks
Title
Undergoing cataract surgery
Description
Self-reported undergoing cataract surgery will be assessed via telephone survey at 1 year.
Time Frame
1 year
Title
Decision regret
Description
The Decision Regret Scale will measure participants' level of regret regarding their initial decision whether to have cataract surgery or not.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Definite diagnosis of age-related cataract; The best corrected visual acuity (BCVA) is above 20/60; 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); Willing to know about cataract and cataract surgery; Being able to afford cataract surgery; Willing to participate in the study and provide the informed content. Exclusion Criteria: Having received cataract surgery; Having hearing disorders; Having mental disorders; Having ocular disorders other than cataract; Having surgery contraindication; Unwilling to participate in this study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yingfeng Zheng, M.D. Ph.D.
Phone
+8613922286455
Email
zhyfeng@mail.sysu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yingfeng Zheng, M.D. Ph.D.
Organizational Affiliation
Zhongshan Ophthalmic Center, Sun Yat-sen Univeristy
Official's Role
Study Director
Facility Information:
Facility Name
Dashi Community Health Center
City
Guangzhou
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yurong Hu
Facility Name
Donghuan Community Health Center
City
Guangzhou
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qiuling Xia
Facility Name
Huangcun Community Health Center
City
Guangzhou
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shaochun Wang
Facility Name
Huaying Community Health Center
City
Guangzhou
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Haifeng Wang
Facility Name
Qiaonan Community Health Center
City
Guangzhou
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Weijian Chen
Facility Name
Shawan Community Health Center
City
Guangzhou
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yu Wong
Facility Name
Shibi Community Health Center
City
Guangzhou
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Feiming Fan
Facility Name
Shiqiao Community Health Center
City
Guangzhou
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhenhong Chen
Facility Name
Xiayuan Community Health Center
City
Guangzhou
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jiang Tan
Facility Name
Yuancun Community Health Center
City
Guangzhou
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Baoli Liu
Facility Name
Zhognshan Ophthalmic Center, Sun Yat-sen University
City
Guangzhou
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yizhi Liu

12. IPD Sharing Statement

Plan to Share IPD
No

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Impact of a Printed Decision Aid on Cataract Surgery Choice

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