Clinical trial NCT03525015: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Age Related Cataracts
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2018-05-15
Enrollment: 696
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility 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.

Primary outcomes:
measure: Informed choice about cataract surgery
timeFrame: 2 weeks
Secondary outcomes:
measure: Perceived importance of cataract surgery benefit/harms
timeFrame: 2 weeks
measure: Perceived personal chances of surgical benefit/harms
timeFrame: 2 weeks
measure: Decisional conflict
timeFrame: 2 weeks
measure: Decisional confidence
timeFrame: 2 weeks
measure: Time perspective
timeFrame: 2 weeks
measure: Anticipated regret
timeFrame: 2 weeks
measure: Cataract worry and anxiety
timeFrame: 2 weeks
measure: Booklet utilization and acceptability
timeFrame: 2 weeks
measure: Undergoing cataract surgery
timeFrame: 1 year
measure: Decision regret
timeFrame: 1 year
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Dashi Community Health Center
city: Guangzhou
country: China
facility: Donghuan Community Health Center
city: Guangzhou
country: China
facility: Huangcun Community Health Center
city: Guangzhou
country: China
facility: Huaying Community Health Center
city: Guangzhou
country: China
facility: Qiaonan Community Health Center
city: Guangzhou
country: China
facility: Shawan Community Health Center
city: Guangzhou
country: China
facility: Shibi Community Health Center
city: Guangzhou
country: China
facility: Shiqiao Community Health Center
city: Guangzhou
country: China
facility: Xiayuan Community Health Center
city: Guangzhou
country: China
facility: Yuancun Community Health Center
city: Guangzhou
country: China
facility: Zhognshan Ophthalmic Center, Sun Yat-sen University
Study officials:
affiliation: Zhongshan Ophthalmic Center, Sun Yat-sen Univeristy
name: Yingfeng Zheng, M.D. Ph.D.
role: STUDY_DIRECTOR
References: