Impact of a Printed Decision Aid on Cataract Surgery Choice

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Sun Yat-sen University

Status

Unknown

Conditions

Age Related Cataracts

Treatments

Other: An usual booklet about cataract and cataract surgery
Other: A decision aid booklet about cataract surgery choice

Study type

Interventional

Funder types

Other

Identifiers

NCT03525015
2017KYPJ066

Details and patient eligibility

About

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.

Full 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.

Enrollment

696 estimated patients

Sex

All

Ages

50 to 80 years old

Volunteers

No 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.

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

696 participants in 2 patient groups

A decision aid booklet
Experimental group
Description:
A decision aid booklet about cataract surgery choice
Treatment:
Other: A decision aid booklet about cataract surgery choice
An usual booklet
Active Comparator group
Description:
An usual booklet about cataract and cataract surgery
Treatment:
Other: An usual booklet about cataract and cataract surgery

Trial contacts and locations

11

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Central trial contact

Yingfeng Zheng, M.D. Ph.D.

Data sourced from clinicaltrials.gov

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