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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04317690
• Other study ID #: 2019P001434-1
• Status: Completed
• Start date: March 17, 2020
• Est. completion date: June 29, 2020

Study information

• Verified date: May 2022
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 539
• Est. completion date: June 29, 2020
• Est. primary completion date: June 29, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Colorectal Cancer
• High Blood Pressure
• High Cholesterol
• Hypercholesterolemia
• Hypertension
• Prostate Cancer

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Carol Cosenza, Center for Survey Research at University of Massachusetts, Boston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adherence	3 item measure of adherence to medication asked for the high cholesterol and high blood pressure sample participants who indicate that they are taking medicine. (patients in the cancer screening arm did not get this question). composite score ranged from 0-100, with higher scores indicating greater adherence to medication within the last 30 days.	Baseline survey
Primary	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	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
Secondary	Decision Regret Scale	5-item decision regret scale ranges from 0-100 with higher scores indicating greater decisional regret.	Baseline survey
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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