Bang for the Buck : Assessing the impact of different features of a web-based decision aid to improve decision making for asymptomatic carotid disease

Study ID
STU 082010-091

Cancer Related
No

Healthy Volunteers
No

Study Sites

  • Parkland Health & Hospital System
  • UT Southwestern Ambulatory Services

Contact
Kimberly Batchelor
214-648-0578
kim.batchelor@utsouthwestern.edu

Principal Investigator
Ethan Halm

Summary

The purpose of this study is to develop a decision aid (DA) to help patients with asymptomatic carotid disease weigh the benefits and risks of surgical vs. medical treatment. This study has three phases:

1. Phase 1. Develop and validate a Decision Quality (DQ) instrument to measure the depth of understanding and quality of informed decision making in carotid disease. This will involve surveying patients and physicians about what they consider important to the treatment decision in carotid disease.

2. Phase 2. A web-based randomized controlled trial to assess the impact of 5 different factors on knowledge, comprehension, and decision quality.

3. Phase 3. Conduct a randomized control trial (RCT) using the DA in patients with carotid disease deciding between medical therapy and surgery. Following the determination of a and amp;apos;best performing and amp;apos; DA, a pilot RCT will be conducted comparing the DA to a standard written patient handout. We will assess: (1) the acceptability of the DA; (2) knowledge and decision quality; (3) how the DA may have influenced the consultation visit with the subject and amp;apos;s physician (4) whether it would be better having the DA before or after the initial consultation.

Participant Eligibility

Phase 1:

Subjects will be included who:

* Have asymptomatic carotid disease

* Read and write English. (The instruments will not be translated into another language due to funding constraints.)

Physicians and nurses will be included who:

* Treat patients with carotid disease

Phase 2:

Study subjects will be included if they:

* Are adults >= 60 years old

* Have one or more risk factors for asymptomatic carotid disease (hypertension, hyperlipidemia, diabetes, coronary artery disease, or peripheral vascular disease

Phase 3:

Subjects will be included who:

* Have asymptomatic carotid disease

* Read and write English. (The decision aid and instruments will not be translated into another language due to funding constraints.)