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

NCT ID: NCT04317690

Last Updated: 2022-05-20

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

539 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-03-17

Study Completion Date

2020-06-29

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.

Conditions

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High Cholesterol High Blood Pressure Colorectal Cancer Breast Cancer Prostate Cancer

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Study Groups

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High Cholesterol

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.

No interventions assigned to this group

High Blood Pressure

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.

No interventions assigned to this group

Colorectal Cancer Screening

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.

No interventions assigned to this group

Breast Cancer Screening

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.

No interventions assigned to this group

Prostate Cancer Screening

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.

No interventions assigned to this group

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
Minimum Eligible Age

30 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Massachusetts, Boston

OTHER

Sponsor Role collaborator

Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Karen Sepucha

Director of the Health Decision Sciences Center

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Karen Sepucha, PhD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

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Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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2019P001434-1

Identifier Type: -

Identifier Source: org_study_id

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