A Decision Aid for Patients With Age-related Cataract

Not Applicable

• Conditions: Age-related Cataract
• Interventions: Other: A usual education booklet; Other: A patient decision aid

• Registration Number: NCT03992807
• Lead Sponsor: Sun Yat-sen University

Brief Summary

To determine whether a decision aid increases informed decision about cataract surgery for patients with age-related cataract.

Detailed Description

The need for cataract surgery is on the rise globally due to the aging population and high demands for greater visual functioning. Patients with age-related cataract face their initial decision about when to undergo cataract surgery. Although the majority of patients want to participate in a shared decision-making process, no decision aid has been available to improve the quality of decision. The purpose of this study is to determine whether a decision aid increases informed decision about cataract surgery for patients with age-related cataract.

Study Timeline

• Study First Submitted: 2019-06-11
• Study First Submitted QC: 2019-06-18
• Study First Posted: 2019-06-20
• Study Start: 2019-07-01
• Primary Completion: 2019-11-12
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-01
• Last Update Posted: 2020-03-03
• Study Completion: 2020-11-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 773

Inclusion Criteria

1. Individuals aged 50-80 years who have been resident in the selected study district for more than six months;
2. A definite diagnosis of age-related cataract;
3. Having not received cataract surgery;
4. Willing to participate in the study and provide informed content.

Exclusion criteria

1. Bilateral blindness (presenting distance visual acuity worse than 3/60);
2. Having ocular, hearing or mental disorder precluding reading or telephone interview;
3. Ocular disorders other than cataract leading to permanent vision loss that could not be corrected through cataract surgery;
4. Having cataract surgery contraindication.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A usual education booklet	A usual education booklet	A traditional booklet with standard general information developed by the National Eye Institute (NEI) to help patients understand cataract.
A patient decision aid	A patient decision aid	A patient decision aid that includes not only the standard general information, but also the quantitative risk information on the possible outcomes of cataract surgery as well as value clarification exercise.

Primary Outcome Measures

Name	Time	Method
Informed choice about cataract surgery (the proportion of participants who make an informed choice，which is defined as a good knowledge score and an intention that is consistent with their attitude score)	2 weeks post intervention	Informed choice is an aggregated measure of multiple measurements, including knowledge (a 12-item questionnaire that assesses conceptual (items 1-10) and numerical (items 11-12) knowledge), attitudes (6 items, with 5 responses for each), and intentions (single item with 5 responses); Analysis: Informed Choice= Good Knowledge (score ≥50% in basic knowledge, ≥40% in knowledge associated with each treatment option, and at least 1 point in each numerical knowledge question) AND Positive Attitude (score ≥24) AND Positive Intention ("definitely will" or "likely to"), OR Good Knowledge AND Negative Attitude (score \<23) AND Negative Intention ("unsure", "not likely to", or "definitely will not")

Secondary Outcome Measures

Name	Time	Method
Cataract worry and anxiety	2 weeks post intervention	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.
Decisional confidence	2 weeks post intervention	Decisional confidence will be assessed using a 11-item Decision Self Efficacy Scale.
Anticipated regret	2 weeks post intervention	Two items from a validated scale will measure anticipated regret about having cataract surgery (action regret) and about not having cataract (inaction regret).
Perceived importance of surgical benefit/harms	2 weeks post intervention	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.
Perceived personal chances of surgical benefit/harms	2 weeks post intervention	Participants will be asked about their perceived personal likelihood of experiencing specific outcomes if they have cataract surgeries, compared with an average patient who had undergone cataract surgery.
Decisional conflict	2 weeks post intervention	Decisional conflict will be assessed using a 16-item Decisional Conflict Scale.
Time perspective	2 weeks post intervention	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.
Heath-related quality of life: Chinese version of the EQ-5D-5L telephone interview script	Baseline, 1 year post intervention	This will be assessed using the simplified Chinese version of the EQ-5D-5L telephone interview script from the EuroQol research foundation.
Costs	Baseline, 1 year post intervention	This will be assessed using the Treatment Inventory of Costs in Patients with psychiatric disorders (TIC-P) questionnaire.
Booklet utilization and acceptability	2 weeks post intervention	Acceptability and utilization of materials will be assessed based on the following items: 1. the proportion of participants who could read the booklet all the way through; 2. the proportion of participants who agree that the information is new; 3. the proportion of participants who agree that the length is just about right; 4. the proportion of participants who think the information is balanced; 5. the proportion of participants who agree that the booklet is clear and easy to understand; 6. the proportion of participants who find the materials helpful; 7. the proportion of participants who feel it worth recommending to others.
Undergoing cataract surgery	1 year post intervention	Self-reported undergoing cataract surgery will be assessed via telephone survey at 1 year.
Decision regret	1 year post intervention	The Decision Regret Scale will measure participants' level of regret regarding their initial decision whether to have cataract surgery or not.
Visual functioning	Baseline, 1 year post intervention	This will be assessed using the Catquest 9SF questionnaire.
Fall questionnaire	1 year post intervention	This will be assessed using a single item question "Did you have any fall in the past 12 months whereby you landed on the ground or floor?"

Trial Locations

Locations (1)

Zhognshan Ophthalmic Center, Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China