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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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High Cholesterol, High Blood Pressure, Colorectal Cancer, Breast Cancer, Prostate Cancer

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| High Cholesterol<br>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<br>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<br>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<br>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<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Shared Decision Making Process Measure | The Shared Decision Making Process is a short patient-reported survey that measures the amount of shared decision making that occurs in an interaction. Scores range from 0-4 where higher values indicate a better shared decision making process occurred. | Baseline survey | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decisional Conflict Tool (SURE) | Measures decisional conflict, consists of 4 yes/no items. Scores range 0-4 where 0 indicates no decisional conflict, and scores 1 to 3 indicate decisional conflict. The measure is often reported as a top-score of 0, thus the percentage of patients with a total score of 0 or no decisional conflict. | Baseline survey | 
| Decision Regret Scale | 5-item decision regret scale ranges from 0-100 with higher scores indicating greater decisional regret. | Baseline survey | 
| Single-Item Measure of Decision Regret | Single item asking If you knew then what you know now, do you think you would make the same decision about [how to manage your high cholesterol/ how to manage your high blood pressure/breast cancer screening/colon cancer screening/ prostate cancer screening]? where the last part varies by group. Response options are: Definitely yes, Probably yes, Probably no, Definitely no | Baseline survey | 
| Treatment Choice | Single item asking patient What did you want to do in regard to (depending on the group) high cholesterol/high blood pressure/colon cancer screening/breast cancer screening/prostate cancer screening | Baseline survey | 
| Adapted Controlled Preference Scale | Single item asking the participant who made the ultimate decision. The categorical response options are 1) the patient made the decision, 2)the provider made the decision, or 3) both patient and provider made the decision together. | Baseline survey | 
| Shared Decision Making Process Measure Retest | The Shared Decision Making Process is a short patient-reported survey that measures the amount of shared decision making that occurs in an interaction. Scores range from 0-4 where higher values indicate a better shared decision making process occurred. | 1 week after baseline survey | 
| Knowledge | Multiple choice knowledge items for each topic will be combined to a total knowledge score (0-100) with higher scores indicating higher knowledge | Baseline survey | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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shared decision making