Online Trial Examining Validity and Reliability of the Shared Decision Making Process Survey

Mass General Brigham

Status: Completed

Conditions: Breast Cancer; High Blood Pressure; Prostate Cancer; High Cholesterol; Colorectal Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT04317690

2019P001434-1

Details and patient eligibility

About

The purpose of this study is to survey a sample of adults who have recently made a decision about treatment of high cholesterol or high blood pressure or a decision about screening for colorectal cancer, breast cancer, or prostate cancer. The main goal is to gather evidence of the validity and reliability of the Shared Decision Making Process scale. Secondary goal is to gather evidence on the quality of decisions for these common medical situations.

Full description

Study staff worked with a national sampling firm to recruit subjects for five different medical decisions. The five decisions are (1) treatment of high cholesterol, (2) treatment of high blood pressure (3) when to start breast cancer screening (4) whether or not to have prostate cancer screening and (5) which test to have for colorectal cancer screening. Respondents complete a survey about their experiences talking with health care providers about the specific clinical decision. The survey measured the amount of shared decision making, knowledge, preferences, decisional conflict and decision regret. The study will obtain 500 responses total, or 100 for each decision.

Sample is an online non-probability panel of adults living in the United States. In the survey, participants were screened to meet specific qualifications. After 1 week, a random selection of 50 respondents are invited to complete the retest instrument.

All analyses will be conducted separately for each group, and results may be pooled across cancer screening and medication contexts. First, study staff will examine the descriptives for the Shared Decision Making Process items. Study staff will also test several hypotheses to examine validity of the scores such as whether higher shared decision making process scores are associated with less decisional conflict and less regret. Staff will also examine retest reliability of the Shared Decision Making Process scale.

Enrollment: 539 patients

Sex: All

Ages: 30 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

High Blood Pressure Group

• Between the ages of 30-75
• No previous heart attack or stroke
• Have been diagnosed with high blood pressure
• Taking medication for high blood pressure for 2 years or less; or have discussed managing high blood pressure in the past 2 years

High Cholesterol

• Between the ages of 30-75
• No previous heart attack or stroke
• Have been diagnosed with high cholesterol
• Taking medication for high cholesterol for 2 years or less; or have discussed managing high cholesterol in the past 2 years

Colorectal Cancer Screening

• Between the ages of 50-75
• No previous diagnosis of colon cancer
• Have been screened for colon cancer (or discussed screening for colon cancer) in the past 2 years
• Had first colon cancer screening in past 2 years

Breast Cancer Screening

• Female
• Between the ages of 40-55
• No previous diagnosis of breast cancer
• Have had mammogram (or discussed having a mammogram) in the past 2 years
• Had first mammogram in past 2 years

Prostate Cancer Screening

• Male
• Between the ages of 45-69
• No previous diagnosis of prostate cancer
• Have been screened for prostate cancer (or discussed screening for prostate cancer) in the past 2 years
• Had first prostate cancer screening in past 2 years

Exclusion criteria

High Blood Pressure Group

• None

High Cholesterol

• None

Colorectal Cancer Screening

• None

Breast Cancer Screening

• None

Prostate Cancer Screening

• None

Trial design

539 participants in 5 patient groups

High Cholesterol

Description:

People between the ages of 30-75 ,with no previous heart attack or stroke history, who have been diagnosed with high cholesterol, who are either taking medication for high cholesterol for 2 years or less; or have discussed managing high cholesterol in the past 2 years. These people will see items only pertaining to high cholesterol.

High Blood Pressure

Description:

People between the ages of 30-75 ,with no previous heart attack or stroke history, who have been diagnosed with high blood pressure, who are either taking medication for high blood pressure for 2 years or less; or have discussed managing high blood pressure in the past 2 years. These people will see items only pertaining to high blood pressure.

Colorectal Cancer Screening

Description:

People between the ages of 50-75 with no previous diagnosis of colon cancer, who have been screened for colon cancer (or discussed screening for colon cancer) in the past 2 years, or who had first colon cancer screening in past 2 years. These people will see items only pertaining to colon cancer screening.

Breast Cancer Screening

Description:

Females between the ages of 40-50 with no previous diagnosis of breast cancer who have had mammogram (or discussed having a mammogram) in the past 2 years, or had first mammogram in past 2 years. These people will see items only pertaining to breast cancer screening.

Prostate Cancer Screening

Description:

Men between the ages of 45-69 with no previous diagnosis of prostate cancer who have been screened for prostate cancer (or discussed screening for prostate cancer) in the past 2 years or had first prostate cancer screening in the past 2 years. These people will see items only pertaining to prostate cancer screening.