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

Sponsor
Massachusetts General Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT04317690
Collaborator
Carol Cosenza, Center for Survey Research at University of Massachusetts, Boston (Other)
539
1
3.4
157.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    539 participants
    Observational Model:
    Other
    Time Perspective:
    Retrospective
    Official Title:
    Online Trial Examining Validity and Reliability of the Shared Decision Making Process Survey
    Actual Study Start Date :
    Mar 17, 2020
    Actual Primary Completion Date :
    Jun 29, 2020
    Actual Study Completion Date :
    Jun 29, 2020

    Arms and Interventions

    Arm Intervention/Treatment
    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.

    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.

    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.

    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.

    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.

    Outcome Measures

    Primary Outcome Measures

    1. Shared Decision Making Process Measure [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 Outcome Measures

    1. Decisional Conflict Tool (SURE) [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 [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 [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 [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 [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 [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 [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 Outcome Measures

    1. Adherence [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    30 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Massachusetts General Hospital Boston Massachusetts United States 02114

    Sponsors and Collaborators

    • Massachusetts General Hospital
    • Carol Cosenza, Center for Survey Research at University of Massachusetts, Boston

    Investigators

    • Principal Investigator: Karen Sepucha, PhD, Massachusetts General Hospital

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Karen Sepucha, Director of the Health Decision Sciences Center, Massachusetts General Hospital
    ClinicalTrials.gov Identifier:
    NCT04317690
    Other Study ID Numbers:
    • 2019P001434-1
    First Posted:
    Mar 23, 2020
    Last Update Posted:
    May 20, 2022
    Last Verified:
    May 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Karen Sepucha, Director of the Health Decision Sciences Center, Massachusetts General Hospital
    Additional relevant MeSH terms:

    Study Results

    Participant Flow

    Recruitment Details March 2020 - July 2020 using a national, non-probability panel obtained from Marketing Systems Group (MSG). MSG recruited participants by sending out invitation emails to potential responders.
    Pre-assignment Detail Eligible respondents were adults in the US who had talked with a healthcare provider about screening for cancer (breast, colon, or prostate) or taking medication for a common chronic condition (depression, high cholesterol, or high blood pressure) in the past two years. Respondents were re-contacted approximately one-week post survey for a re-test survey.
    Arm/Group Title High Cholesterol High Blood Pressure Colorectal Cancer Screening Breast Cancer Screening Prostate Cancer Screening
    Arm/Group Description 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. 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. 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. 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. 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.
    Period Title: Overall Study
    STARTED 100 100 140 100 99
    COMPLETED 100 96 140 98 99
    NOT COMPLETED 0 4 0 2 0

    Baseline Characteristics

    Arm/Group Title High Cholesterol High Blood Pressure Colorectal Cancer Screening Breast Cancer Screening Prostate Cancer Screening Total
    Arm/Group Description 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. 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. 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. 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. 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. Total of all reporting groups
    Overall Participants 100 96 140 98 99 533
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    52
    (12)
    43
    (11)
    61
    (7)
    44
    (3)
    52
    (4)
    52
    (11)
    Sex: Female, Male (Count of Participants)
    Female
    63
    63%
    41
    42.7%
    43
    30.7%
    98
    100%
    0
    0%
    245
    46%
    Male
    37
    37%
    55
    57.3%
    97
    69.3%
    0
    0%
    99
    100%
    288
    54%
    Ethnicity (NIH/OMB) (Count of Participants)
    Hispanic or Latino
    10
    10%
    11
    11.5%
    10
    7.1%
    8
    8.2%
    6
    6.1%
    45
    8.4%
    Not Hispanic or Latino
    90
    90%
    85
    88.5%
    130
    92.9%
    90
    91.8%
    93
    93.9%
    488
    91.6%
    Unknown or Not Reported
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    0
    0%
    1
    1%
    1
    0.7%
    0
    0%
    1
    1%
    3
    0.6%
    Asian
    4
    4%
    2
    2.1%
    4
    2.9%
    7
    7.1%
    0
    0%
    17
    3.2%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Black or African American
    8
    8%
    11
    11.5%
    16
    11.4%
    9
    9.2%
    17
    17.2%
    61
    11.4%
    White
    78
    78%
    74
    77.1%
    112
    80%
    75
    76.5%
    75
    75.8%
    414
    77.7%
    More than one race
    3
    3%
    4
    4.2%
    2
    1.4%
    2
    2%
    1
    1%
    12
    2.3%
    Unknown or Not Reported
    7
    7%
    4
    4.2%
    5
    3.6%
    5
    5.1%
    5
    5.1%
    26
    4.9%
    Race and Ethnicity Not Collected (Count of Participants)
    Count of Participants [Participants]
    0
    0%

    Outcome Measures

    1. Primary Outcome
    Title Shared Decision Making Process Measure
    Description 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.
    Time Frame Baseline survey

    Outcome Measure Data

    Analysis Population Description
    participants who provided complete information to calculate a shared decision making process score (primary outcome of interest)
    Arm/Group Title High Cholesterol High Blood Pressure Colorectal Cancer Screening Breast Cancer Screening Prostate Cancer Screening
    Arm/Group Description 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. 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. 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. 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. 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.
    Measure Participants 100 96 140 98 99
    Mean (Standard Deviation) [score on a scale]
    2.12
    (1.03)
    2.65
    (1.04)
    1.61
    (1.12)
    1.4
    (1.1)
    1.87
    (0.97)
    2. Secondary Outcome
    Title Decisional Conflict Tool (SURE)
    Description 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.
    Time Frame Baseline survey

    Outcome Measure Data

    Analysis Population Description
    participants who completed all 4 items of the short decisional conflict scale. Only 532/533 participants provided enough information to calculate a SURE score.
    Arm/Group Title High Cholesterol High Blood Pressure Colorectal Cancer Screening Breast Cancer Screening Prostate Cancer Screening
    Arm/Group Description 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. 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. 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. 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. 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.
    Measure Participants 100 96 139 98 99
    Number [percentage of participants]
    68
    68%
    70
    72.9%
    68
    48.6%
    78
    79.6%
    71
    71.7%
    3. Secondary Outcome
    Title Decision Regret Scale
    Description 5-item decision regret scale ranges from 0-100 with higher scores indicating greater decisional regret.
    Time Frame Baseline survey

    Outcome Measure Data

    Analysis Population Description
    Participants who answered all 5 decision regret questions. Only 526/533 participants provided enough information to calculate decision regret score.
    Arm/Group Title High Cholesterol High Blood Pressure Colorectal Cancer Screening Breast Cancer Screening Prostate Cancer Screening
    Arm/Group Description 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. 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. 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. 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. 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.
    Measure Participants 100 94 139 95 98
    Mean (Standard Deviation) [score on a scale]
    22
    (18)
    27
    (18)
    17
    (18)
    16
    (16)
    25
    (22)
    4. Secondary Outcome
    Title Single-Item Measure of Decision Regret
    Description 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
    Time Frame Baseline survey

    Outcome Measure Data

    Analysis Population Description
    participants who answered the single-item regret question.
    Arm/Group Title High Cholesterol High Blood Pressure Colorectal Cancer Screening Breast Cancer Screening Prostate Cancer Screening
    Arm/Group Description 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. 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. 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. 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. 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.
    Measure Participants 100 96 140 98 99
    Definitely yes
    49
    49%
    52
    54.2%
    77
    55%
    61
    62.2%
    50
    50.5%
    Probably yes
    44
    44%
    37
    38.5%
    54
    38.6%
    32
    32.7%
    39
    39.4%
    Probably no
    5
    5%
    7
    7.3%
    8
    5.7%
    4
    4.1%
    7
    7.1%
    Definitely no
    2
    2%
    0
    0%
    1
    0.7%
    1
    1%
    3
    3%
    5. Secondary Outcome
    Title Treatment Choice
    Description 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
    Time Frame Baseline survey

    Outcome Measure Data

    Analysis Population Description
    participants who answered the treatment preference question.
    Arm/Group Title High Cholesterol High Blood Pressure Colorectal Cancer Screening Breast Cancer Screening Prostate Cancer Screening
    Arm/Group Description 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. 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. 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. 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. 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.
    Measure Participants 100 96 140 97 99
    take medicine/(start) screen for cancer
    37
    37%
    64
    66.7%
    123
    87.9%
    72
    73.5%
    71
    71.7%
    not take medicine/(wait) not screen for cancer
    61
    61%
    32
    33.3%
    16
    11.4%
    19
    19.4%
    25
    25.3%
    other
    2
    2%
    0
    0%
    1
    0.7%
    6
    6.1%
    3
    3%
    6. Secondary Outcome
    Title Adapted Controlled Preference Scale
    Description 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.
    Time Frame Baseline survey

    Outcome Measure Data

    Analysis Population Description
    participants who answered the controlled preference scale question.
    Arm/Group Title High Cholesterol High Blood Pressure Colorectal Cancer Screening Breast Cancer Screening Prostate Cancer Screening
    Arm/Group Description 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. 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. 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. 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. 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.
    Measure Participants 100 96 140 98 99
    Mainly my decision
    43
    43%
    46
    47.9%
    59
    42.1%
    49
    50%
    68
    68.7%
    Mainly the healthcare provider's decision
    18
    18%
    24
    25%
    25
    17.9%
    13
    13.3%
    10
    10.1%
    We made the decision together
    39
    39%
    26
    27.1%
    56
    40%
    36
    36.7%
    21
    21.2%
    7. Secondary Outcome
    Title Shared Decision Making Process Measure Retest
    Description 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.
    Time Frame 1 week after baseline survey

    Outcome Measure Data

    Analysis Population Description
    Participants who completed the baseline survey were re-contacted approximately 1 week post-survey for a retest. Participants who completed the retest survey and provided enough information to calculate the shared decision making process score were part of this analysis.
    Arm/Group Title High Cholesterol High Blood Pressure Colorectal Cancer Screening Breast Cancer Screening Prostate Cancer Screening
    Arm/Group Description 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. 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. 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. 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. 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.
    Measure Participants 45 40 65 42 38
    Mean (Standard Deviation) [score on a scale]
    2.27
    (1.02)
    2.32
    (1.42)
    1.68
    (1.13)
    1.57
    (1.18)
    1.67
    (1.02)
    8. Secondary Outcome
    Title Knowledge
    Description Multiple choice knowledge items for each topic will be combined to a total knowledge score (0-100) with higher scores indicating higher knowledge
    Time Frame Baseline survey

    Outcome Measure Data

    Analysis Population Description
    participants who answered at least 50% of the knowledge items in their respective clinical groups. Participants in the high cholesterol group were not given a knowledge score. Only 131/234 provided enough information to calculate a shared decision making process score (primary outcome of interest)
    Arm/Group Title High Cholesterol High Blood Pressure Colorectal Cancer Screening Breast Cancer Screening Prostate Cancer Screening
    Arm/Group Description 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. 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. 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. 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. 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.
    Measure Participants 0 96 137 98 99
    Mean (Standard Deviation) [score on a scale]
    61
    (29)
    56
    (22)
    40
    (18)
    43
    (26)
    9. Other Pre-specified Outcome
    Title Adherence
    Description 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.
    Time Frame Baseline survey

    Outcome Measure Data

    Analysis Population Description
    participants in the high cholesterol and high blood pressure groups who answered all 3 medication adherence questions. participants in the three cancer screening groups were not assigned medication adherence questions and thus were not part of this analysis. Only 56/100 (high cholesterol) and 68/96 (high blood pressure) participants provided enough information to calculate adherence score.
    Arm/Group Title High Cholesterol High Blood Pressure Colorectal Cancer Screening Breast Cancer Screening Prostate Cancer Screening
    Arm/Group Description 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. 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. 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. 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. 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.
    Measure Participants 56 68 0 0 0
    Mean (Standard Deviation) [score on a scale]
    85
    (19)
    87
    (14)

    Adverse Events

    Time Frame Surveys responses were reviewed within 2 weeks of completion for evidence of adverse events
    Adverse Event Reporting Description Our definition of adverse event and/or serious adverse event did not differ.
    Arm/Group Title High Cholesterol High Blood Pressure Colorectal Cancer Screening Breast Cancer Screening Prostate Cancer Screening
    Arm/Group Description 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. 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. 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. 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. 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.
    All Cause Mortality
    High Cholesterol High Blood Pressure Colorectal Cancer Screening Breast Cancer Screening Prostate Cancer Screening
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/100 (0%) 0/100 (0%) 0/140 (0%) 0/100 (0%) 0/99 (0%)
    Serious Adverse Events
    High Cholesterol High Blood Pressure Colorectal Cancer Screening Breast Cancer Screening Prostate Cancer Screening
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/100 (0%) 0/100 (0%) 0/140 (0%) 0/100 (0%) 0/99 (0%)
    Other (Not Including Serious) Adverse Events
    High Cholesterol High Blood Pressure Colorectal Cancer Screening Breast Cancer Screening Prostate Cancer Screening
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/100 (0%) 0/100 (0%) 0/140 (0%) 0/100 (0%) 0/99 (0%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Dr. Karen R. Sepucha
    Organization Massachusetts General Hospital
    Phone 617-724-3350
    Email KSEPUCHA@mgh.havard.edu
    Responsible Party:
    Karen Sepucha, Director of the Health Decision Sciences Center, Massachusetts General Hospital
    ClinicalTrials.gov Identifier:
    NCT04317690
    Other Study ID Numbers:
    • 2019P001434-1
    First Posted:
    Mar 23, 2020
    Last Update Posted:
    May 20, 2022
    Last Verified:
    May 1, 2022