Clinical trial NCT04317690: Online Trial Examining Validity and Reliability of the Shared Decision Making Process Survey
Official title: Online Trial Examining Validity and Reliability of the Shared Decision Making Process Survey
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: High Cholesterol
High Blood Pressure
Colorectal Cancer
Breast Cancer
Prostate Cancer
Keywords: shared decision making
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: University of Massachusetts, Boston
First posted: 2020-03-23
Enrollment: 539
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Sample was an online non-probability panel of adults living in the United States. Marketing Systems Group, the sample vendor, invited potential respondents from a targeted panel consisting of participants matching the sex, age, and group dynamics described above. In the survey, they were screened to meet our specific qualifications noted above.

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Shared Decision Making Process Measure
timeFrame: Baseline survey
Secondary outcomes:
measure: Decisional Conflict Tool (SURE)
timeFrame: Baseline survey
measure: Decision Regret Scale
timeFrame: Baseline survey
measure: Single-Item Measure of Decision Regret
timeFrame: Baseline survey
measure: Treatment Choice
timeFrame: Baseline survey
measure: Adapted Controlled Preference Scale
timeFrame: Baseline survey
measure: Shared Decision Making Process Measure Retest
timeFrame: 1 week after baseline survey
measure: Knowledge
timeFrame: Baseline survey
Other outcomes:
measure: Adherence
timeFrame: Baseline survey
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Karen Sepucha, PhD
role: PRINCIPAL_INVESTIGATOR
References: