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NCT Number: NCT04317690

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

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.

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Key information

Conditions

High Cholesterol Breast Cancer Breast Diseases Breast Neoplasms Cardiovascular Diseases Colonic Diseases Colorectal Cancer Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Dyslipidemias Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Male Genital Neoplasms, Male High Blood Pressure Hypercholesterolemia Hyperlipidemias Hypertension Intestinal Diseases Intestinal Neoplasms Lipid Metabolism Disorders Male Urogenital Diseases Metabolic Diseases Neoplasms Neoplasms by Site Nutritional and Metabolic Diseases Prostate Cancer Prostatic Diseases Prostatic Neoplasms Rectal Diseases Skin Diseases Skin and Connective Tissue Diseases Urogenital Diseases Urogenital Neoplasms Vascular Diseases

Age range

30 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Shared Decision Making Process Measure

    Time frame: Baseline survey

    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.

Secondary outcomes

  1. Decisional Conflict Tool (SURE)

    Time frame: Baseline survey

    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.

  2. Decision Regret Scale

    Time frame: Baseline survey

    5-item decision regret scale ranges from 0-100 with higher scores indicating greater decisional regret.

  3. Single-Item Measure of Decision Regret

    Time frame: Baseline survey

    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

  4. Treatment Choice

    Time frame: Baseline survey

    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

  5. Adapted Controlled Preference Scale

    Time frame: Baseline survey

    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.

  6. Shared Decision Making Process Measure Retest

    Time frame: 1 week after baseline survey

    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.

  7. Knowledge

    Time frame: Baseline survey

    Multiple choice knowledge items for each topic will be combined to a total knowledge score (0-100) with higher scores indicating higher knowledge

Other outcomes

  1. Adherence

    Time frame: Baseline survey

    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.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • University of Massachusetts, Boston

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Mar 23, 2020
Registry last updated
May 20, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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