High CholesterolNCT04317690
Online Trial Examining Validity and Reliability of the Shared Decision Making Process Survey
An observational study of High Cholesterol and High Blood Pressure, run by Massachusetts General Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- High Cholesterol, High Blood Pressure, Colorectal Cancer
- How many people
- 539 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Mar 2020to 29 Jun 2020
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Sample was an online non-probability panel of adults living in the United States. Marketing Systems Group, the sample vendor, invited potential respondents from a targeted panel consisting of participants matching the sex, age, and group dynamics described above. In the survey, they were screened to meet our specific qualifications noted above.
Who may be able to join
- 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
Show all 27Show fewer
- 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
Who cannot join
- High Blood Pressure Group
- None
- High Cholesterol
- None
- Colorectal Cancer Screening
- None
Show all 10Show fewer
- Breast Cancer Screening
- None
- Prostate Cancer Screening
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
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.
Read the 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.
- Keywords
- shared decision making
- Medical subject headings
- Hypercholesterolemia, Hypertension, Colorectal Neoplasms, Breast Neoplasms, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline survey
Secondary outcomes (7)
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.
Measured: Baseline survey
Decision Regret Scale
5-item decision regret scale ranges from 0-100 with higher scores indicating greater decisional regret.
Measured: Baseline survey
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
Measured: Baseline survey
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
Measured: Baseline survey
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.
Measured: Baseline survey
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.
Measured: 1 week after baseline survey
Knowledge
Multiple choice knowledge items for each topic will be combined to a total knowledge score (0-100) with higher scores indicating higher knowledge
Measured: Baseline survey
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2020
- Study start17 Mar 2020
- Primary completion29 Jun 2020
- Study completion29 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for High CholesterolStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 539 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Massachusetts, Boston
- Responsible party
- Principal investigator, Karen Sepucha, Massachusetts General Hospital
- Investigators
- Karen Sepucha, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04317690
- Sponsor's protocol ID
- 2019P001434-1
- Status last verified
- May 2022
- First submitted
- 19 Mar 2020
- Last updated
- 20 May 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The study team will create a complete, cleaned, de-identified copy of the final data set for each online field test.
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Online Trial Examining Validity and Reliability of the Shared Decision Making Process Survey
- ClinicalTrials.gov ID
- NCT04317690
- Acronym / sponsor ID
- 2019P001434-1
- Keywords
- shared decision making
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 539 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- University of Massachusetts, Boston
- Study start
- 17 Mar 2020 (actual)
- Primary completion
- 29 Jun 2020 (actual)
- Study completion
- 29 Jun 2020 (actual)
- First posted
- 23 Mar 2020 (actual)
- Results
- Posted 20 May 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Sample was an online non-probability panel of adults living in the United States. Marketing Systems Group, the sample vendor, invited potential respondents from a targeted panel consisting of participants matching the sex, age, and group dynamics described above. In the survey, they were screened to meet our specific qualifications noted above.
Key inclusion criteria (27 listed)
- 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
Key exclusion criteria (10 listed)
- High Blood Pressure Group
- None
- High Cholesterol
- None
- Colorectal Cancer Screening
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Shared Decision Making Process Measure
Time frame: Baseline survey
The Shared Decision Making Process is a short patient-reported survey that measures the amount of shared decision making that occurs in an interaction. Scores range from 0-4 where higher values indicate a better shared decision making process occurred.
7 secondary outcomes
Decisional Conflict Tool (SURE)
Time frame: Baseline survey
Decision Regret Scale
Time frame: Baseline survey
Single-Item Measure of Decision Regret
Time frame: Baseline survey
Treatment Choice
Time frame: Baseline survey
Adapted Controlled Preference Scale
Time frame: Baseline survey
Shared Decision Making Process Measure Retest
Time frame: 1 week after baseline survey
Knowledge
Time frame: Baseline survey
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. The study team will create a complete, cleaned, de-identified copy of the final data set for each online field test.
Related trials for High Cholesterol
Active, not recruitingObservational study
Study Evaluating LDL-C Change and Adherence to Inclisiran Lipid-lowering Therapy in ASCVD
Primary Hypercholesterolemia, Mixed Dyslipidemia
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
RecruitingObservational study
Causes and Natural History of Dyslipidemias
Hypercholesterolemia, Atherosclerosis
Active, not recruitingObservational study
Early Detection of Familial Hypercholesterolaemia in Pre-school Children ( CzeCH-IT)
Familial Hypercholesterolaemia
Not yet recruiting
Penn Family Screening for Familial Hypercholesterolemia (NHLBI R33) Trial 3
Familial Hypercholesterolemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karen Sepucha, PhD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of High Cholesterol and High Blood Pressure, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 27 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 May 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Shared Decision Making Process Measure (time frame: Baseline survey). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2022.