Breast Cancer, Colorectal Cancer, High Blood Pressure, High Cholesterol, Prostate Cancer
Conditions
Keywords
shared decision making
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.
Interventions
None listed
Sponsors
University of Massachusetts, Boston
Massachusetts General Hospital
Study design
Observational model
OTHER
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
30 Years to 75 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Decision Regret Scale | Baseline survey | 5-item decision regret scale ranges from 0-100 with higher scores indicating greater decisional regret. |
| 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 |
| 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. |
| 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. |
| 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 |
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
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 details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 100 |
| 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. | 96 |
| 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. | 140 |
| 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. | 98 |
| 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. | 99 |
| Total | 533 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | did not have complete information for primary outcome | 0 | 4 | 0 | 2 | 0 |
Baseline characteristics
| Characteristic | High Blood Pressure | High Cholesterol | Colorectal Cancer Screening | Breast Cancer Screening | Prostate Cancer Screening | Total |
|---|---|---|---|---|---|---|
| Age, Continuous | 43 years STANDARD_DEVIATION 11 | 52 years STANDARD_DEVIATION 12 | 61 years STANDARD_DEVIATION 7 | 44 years STANDARD_DEVIATION 3 | 52 years STANDARD_DEVIATION 4 | 52 years STANDARD_DEVIATION 11 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 11 Participants | 10 Participants | 10 Participants | 8 Participants | 6 Participants | 45 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 85 Participants | 90 Participants | 130 Participants | 90 Participants | 93 Participants | 488 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race and Ethnicity Not Collected | — | — | — | — | — | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 4 Participants | 4 Participants | 7 Participants | 0 Participants | 17 Participants |
| Race (NIH/OMB) Black or African American | 11 Participants | 8 Participants | 16 Participants | 9 Participants | 17 Participants | 61 Participants |
| Race (NIH/OMB) More than one race | 4 Participants | 3 Participants | 2 Participants | 2 Participants | 1 Participants | 12 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants | 7 Participants | 5 Participants | 5 Participants | 5 Participants | 26 Participants |
| Race (NIH/OMB) White | 74 Participants | 78 Participants | 112 Participants | 75 Participants | 75 Participants | 414 Participants |
| Sex: Female, Male Female | 41 Participants | 63 Participants | 43 Participants | 98 Participants | 0 Participants | 245 Participants |
| Sex: Female, Male Male | 55 Participants | 37 Participants | 97 Participants | 0 Participants | 99 Participants | 288 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 100 | 0 / 100 | 0 / 140 | 0 / 100 | 0 / 99 |
| other Total, other adverse events | 0 / 100 | 0 / 100 | 0 / 140 | 0 / 100 | 0 / 99 |
| serious Total, serious adverse events | 0 / 100 | 0 / 100 | 0 / 140 | 0 / 100 | 0 / 99 |
Outcome results
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.
Time frame: Baseline survey
Population: participants who provided complete information to calculate a shared decision making process score (primary outcome of interest)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High Cholesterol | Shared Decision Making Process Measure | 2.12 score on a scale | Standard Deviation 1.03 |
| High Blood Pressure | Shared Decision Making Process Measure | 2.65 score on a scale | Standard Deviation 1.04 |
| Colorectal Cancer Screening | Shared Decision Making Process Measure | 1.61 score on a scale | Standard Deviation 1.12 |
| Breast Cancer Screening | Shared Decision Making Process Measure | 1.4 score on a scale | Standard Deviation 1.1 |
| Prostate Cancer Screening | Shared Decision Making Process Measure | 1.87 score on a scale | Standard Deviation 0.97 |
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.
Time frame: Baseline survey
Population: participants who answered the controlled preference scale question.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| High Cholesterol | Adapted Controlled Preference Scale | Mainly my decision | 43 Participants |
| High Cholesterol | Adapted Controlled Preference Scale | We made the decision together | 39 Participants |
| High Cholesterol | Adapted Controlled Preference Scale | Mainly the healthcare provider's decision | 18 Participants |
| High Blood Pressure | Adapted Controlled Preference Scale | Mainly the healthcare provider's decision | 24 Participants |
| High Blood Pressure | Adapted Controlled Preference Scale | Mainly my decision | 46 Participants |
| High Blood Pressure | Adapted Controlled Preference Scale | We made the decision together | 26 Participants |
| Colorectal Cancer Screening | Adapted Controlled Preference Scale | Mainly the healthcare provider's decision | 25 Participants |
| Colorectal Cancer Screening | Adapted Controlled Preference Scale | Mainly my decision | 59 Participants |
| Colorectal Cancer Screening | Adapted Controlled Preference Scale | We made the decision together | 56 Participants |
| Breast Cancer Screening | Adapted Controlled Preference Scale | Mainly my decision | 49 Participants |
| Breast Cancer Screening | Adapted Controlled Preference Scale | We made the decision together | 36 Participants |
| Breast Cancer Screening | Adapted Controlled Preference Scale | Mainly the healthcare provider's decision | 13 Participants |
| Prostate Cancer Screening | Adapted Controlled Preference Scale | Mainly the healthcare provider's decision | 10 Participants |
| Prostate Cancer Screening | Adapted Controlled Preference Scale | Mainly my decision | 68 Participants |
| Prostate Cancer Screening | Adapted Controlled Preference Scale | We made the decision together | 21 Participants |
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.
Time frame: Baseline survey
Population: 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 | Measure | Value (NUMBER) |
|---|---|---|
| High Cholesterol | Decisional Conflict Tool (SURE) | 68 percentage of participants |
| High Blood Pressure | Decisional Conflict Tool (SURE) | 70 percentage of participants |
| Colorectal Cancer Screening | Decisional Conflict Tool (SURE) | 68 percentage of participants |
| Breast Cancer Screening | Decisional Conflict Tool (SURE) | 78 percentage of participants |
| Prostate Cancer Screening | Decisional Conflict Tool (SURE) | 71 percentage of participants |
Secondary
Decision Regret Scale
5-item decision regret scale ranges from 0-100 with higher scores indicating greater decisional regret.
Time frame: Baseline survey
Population: Participants who answered all 5 decision regret questions. Only 526/533 participants provided enough information to calculate decision regret score.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High Cholesterol | Decision Regret Scale | 22 score on a scale | Standard Deviation 18 |
| High Blood Pressure | Decision Regret Scale | 27 score on a scale | Standard Deviation 18 |
| Colorectal Cancer Screening | Decision Regret Scale | 17 score on a scale | Standard Deviation 18 |
| Breast Cancer Screening | Decision Regret Scale | 16 score on a scale | Standard Deviation 16 |
| Prostate Cancer Screening | Decision Regret Scale | 25 score on a scale | Standard Deviation 22 |
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
Time frame: Baseline survey
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High Blood Pressure | Knowledge | 61 score on a scale | Standard Deviation 29 |
| Colorectal Cancer Screening | Knowledge | 56 score on a scale | Standard Deviation 22 |
| Breast Cancer Screening | Knowledge | 40 score on a scale | Standard Deviation 18 |
| Prostate Cancer Screening | Knowledge | 43 score on a scale | Standard Deviation 26 |
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.
Time frame: 1 week after baseline survey
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High Cholesterol | Shared Decision Making Process Measure Retest | 2.27 score on a scale | Standard Deviation 1.02 |
| High Blood Pressure | Shared Decision Making Process Measure Retest | 2.32 score on a scale | Standard Deviation 1.42 |
| Colorectal Cancer Screening | Shared Decision Making Process Measure Retest | 1.68 score on a scale | Standard Deviation 1.13 |
| Breast Cancer Screening | Shared Decision Making Process Measure Retest | 1.57 score on a scale | Standard Deviation 1.18 |
| Prostate Cancer Screening | Shared Decision Making Process Measure Retest | 1.67 score on a scale | Standard Deviation 1.02 |
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
Time frame: Baseline survey
Population: participants who answered the single-item regret question.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| High Cholesterol | Single-Item Measure of Decision Regret | Definitely yes | 49 Participants |
| High Cholesterol | Single-Item Measure of Decision Regret | Probably yes | 44 Participants |
| High Cholesterol | Single-Item Measure of Decision Regret | Probably no | 5 Participants |
| High Cholesterol | Single-Item Measure of Decision Regret | Definitely no | 2 Participants |
| High Blood Pressure | Single-Item Measure of Decision Regret | Definitely yes | 52 Participants |
| High Blood Pressure | Single-Item Measure of Decision Regret | Definitely no | 0 Participants |
| High Blood Pressure | Single-Item Measure of Decision Regret | Probably yes | 37 Participants |
| High Blood Pressure | Single-Item Measure of Decision Regret | Probably no | 7 Participants |
| Colorectal Cancer Screening | Single-Item Measure of Decision Regret | Definitely no | 1 Participants |
| Colorectal Cancer Screening | Single-Item Measure of Decision Regret | Probably yes | 54 Participants |
| Colorectal Cancer Screening | Single-Item Measure of Decision Regret | Probably no | 8 Participants |
| Colorectal Cancer Screening | Single-Item Measure of Decision Regret | Definitely yes | 77 Participants |
| Breast Cancer Screening | Single-Item Measure of Decision Regret | Definitely yes | 61 Participants |
| Breast Cancer Screening | Single-Item Measure of Decision Regret | Probably yes | 32 Participants |
| Breast Cancer Screening | Single-Item Measure of Decision Regret | Definitely no | 1 Participants |
| Breast Cancer Screening | Single-Item Measure of Decision Regret | Probably no | 4 Participants |
| Prostate Cancer Screening | Single-Item Measure of Decision Regret | Definitely no | 3 Participants |
| Prostate Cancer Screening | Single-Item Measure of Decision Regret | Probably no | 7 Participants |
| Prostate Cancer Screening | Single-Item Measure of Decision Regret | Probably yes | 39 Participants |
| Prostate Cancer Screening | Single-Item Measure of Decision Regret | Definitely yes | 50 Participants |
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
Time frame: Baseline survey
Population: participants who answered the treatment preference question.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| High Cholesterol | Treatment Choice | not take medicine/(wait) not screen for cancer | 61 Participants |
| High Cholesterol | Treatment Choice | take medicine/(start) screen for cancer | 37 Participants |
| High Cholesterol | Treatment Choice | other | 2 Participants |
| High Blood Pressure | Treatment Choice | not take medicine/(wait) not screen for cancer | 32 Participants |
| High Blood Pressure | Treatment Choice | take medicine/(start) screen for cancer | 64 Participants |
| High Blood Pressure | Treatment Choice | other | 0 Participants |
| Colorectal Cancer Screening | Treatment Choice | other | 1 Participants |
| Colorectal Cancer Screening | Treatment Choice | take medicine/(start) screen for cancer | 123 Participants |
| Colorectal Cancer Screening | Treatment Choice | not take medicine/(wait) not screen for cancer | 16 Participants |
| Breast Cancer Screening | Treatment Choice | not take medicine/(wait) not screen for cancer | 19 Participants |
| Breast Cancer Screening | Treatment Choice | take medicine/(start) screen for cancer | 72 Participants |
| Breast Cancer Screening | Treatment Choice | other | 6 Participants |
| Prostate Cancer Screening | Treatment Choice | not take medicine/(wait) not screen for cancer | 25 Participants |
| Prostate Cancer Screening | Treatment Choice | take medicine/(start) screen for cancer | 71 Participants |
| Prostate Cancer Screening | Treatment Choice | other | 3 Participants |
Other Pre-specified
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.
Time frame: Baseline survey
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High Cholesterol | Adherence | 85 score on a scale | Standard Deviation 19 |
| High Blood Pressure | Adherence | 87 score on a scale | Standard Deviation 14 |