Online Trial Examining Validity and Reliability of the Shared Decision Making Process Survey
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
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
- 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
- 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
- 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
- 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
Other Outcome Measures
- 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
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.- 2019P001434-1
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
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)
|
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%
|
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)
|
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%
|
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%
|
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%
|
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)
|
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)
|
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
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 |
KSEPUCHA@mgh.havard.edu |
- 2019P001434-1