CommunicationSBINCT01501006
Social and Behavioral Influence (SBI)
An observational study of Communication, run by University of Rochester at 1 site in United States.
Trial summary
The purpose of the study is to improve patient-physician communication and clinical decisions in the context of serious illness that may affect important clinical outcomes. The investigators will examine how variations in communication patterns and clinical decisions are affected by patient demographics (e.g age… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Communication
- How many people
- 96 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2010to Mar 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Male and Female physicians of all races and ethnicities
Who may be able to join
- Currently in clinical practice
- Do not plan on moving during the next year
Who cannot join
- Non-physicians
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Social and Behavioral Influences on Clinical Care
The purpose of the study is to improve patient-physician communication and clinical decisions in the context of serious illness that may affect important clinical outcomes. The investigators will examine how variations in communication patterns and clinical decisions are affected by patient demographics (e.g age, sex), patient interactional style (e.g. communication behaviors) and physician characteristics (e.g. attitudes, background, training).
Read the detailed description
This will be a randomized field experiment. Physicians will receive two unannounced covert standardized patient (SP) visits during the 12-24 months after enrollment. SPs are trained actors who will pose as patients to assess physician behavior and communication. Each SP will present just like a real patient, and will have a standardized fabricated scenario and identity. The SP visit will be unannounced; the physician will not be informed at the time of the visit that they are seeing an SP. The visits will be covertly audio-recorded. This is being conducted at 3 sites: University of Rochester, Rochester, NY; Purdue, IN; and University of Michigan.
- Conditions
- Communication
- Keywords
- Physicians
- Medical subject headings
- Communication
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 |
|---|---|---|
| Patient Roles | Physician communication styles will be evaluated with different patient roles. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physicians Communication Style
To examine the degree to which physicians communication style (ex inclusive, authoritative) and clinical decisions (ex. aggressive,passive) differ according to patient characteristics. Unit of Measure: Audio recordings of office visits, will be transcribed, deidentified, and coded.
Measured: 2 years
Secondary outcomes (1)
Physician Communication Moderators (Sex,Class)
To examine how patients participating in their care reduces these patient-specific differences in physician communication behaviors and decisions. Unit of Measure: Audio recordings of office visits, will be transcribed, deidentified, and coded.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2011 (estimated)
- Study startOct 2010
- Primary completionMar 2017
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for CommunicationStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Ronald Epstein, University of Rochester
- Investigators
- Ronald Epstein, MD, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01501006
- Sponsor's protocol ID
- 33086
- Other IDs
- R01CA155376-01
- Acronym
- SBI
- Status last verified
- Mar 2018
- First submitted
- 30 Nov 2011
- Last updated
- 20 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Shields CG, Griggs JJ, Fiscella K, Elias CM, Christ SL, Colbert J, Henry SG, Hoh BG, Hunte HER, Marshall M, Mohile SG, Plumb S, Tejani MA, Venuti A, Epstein RM. The Influence of Patient Race and Activation on Pain Management in Advanced Lung Cancer: a Randomized Field Experiment. J Gen Intern Med. 2019 Mar;34(3):435-442. doi: 10.1007/s11606-018-4785-z. Epub 2019 Jan 10.
PubMed 30632104Elias CM, Shields CG, Griggs JJ, Fiscella K, Christ SL, Colbert J, Henry SG, Hoh BG, Hunte HER, Marshall M, Mohile SG, Plumb S, Tejani MA, Venuti A, Epstein RM. The social and behavioral influences (SBI) study: study design and rationale for studying the effects of race and activation on cancer pain management. BMC Cancer. 2017 Aug 25;17(1):575. doi: 10.1186/s12885-017-3564-2.
PubMed 28841847
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Social and Behavioral Influences on Clinical Care
- ClinicalTrials.gov ID
- NCT01501006
- Acronym / sponsor ID
- SBI / 33086
- Conditions
- Communication
- Keywords
- Physicians
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI)
- Study start
- Oct 2010
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 29 Dec 2011 (estimated)
- Results
- Not posted in the source record
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 the study is to improve patient-physician communication and clinical decisions in the context of serious illness that may affect important clinical outcomes. The investigators will examine how variations in communication patterns and clinical decisions are affected by patient demographics (e.g age, sex), patient interactional style (e.g. communication behaviors) and physician characteristics (e.g. attitudes, background, training).
Detailed description
This will be a randomized field experiment. Physicians will receive two unannounced covert standardized patient (SP) visits during the 12-24 months after enrollment. SPs are trained actors who will pose as patients to assess physician behavior and communication. Each SP will present just like a real patient, and will have a standardized fabricated scenario and identity. The SP visit will be unannounced; the physician will not be informed at the time of the visit that they are seeing an SP. The visits will be covertly audio-recorded. This is being conducted at 3 sites: University of Rochester, Rochester, NY; Purdue, IN; and University of Michigan.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient Roles | – | –Physician communication styles will be evaluated with different patient roles. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Male and Female physicians of all races and ethnicities
Key inclusion criteria (2 listed)
- Currently in clinical practice
- Do not plan on moving during the next year
Key exclusion criteria (1 listed)
- Non-physicians
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
Physicians Communication Style
Time frame: 2 years
To examine the degree to which physicians communication style (ex inclusive, authoritative) and clinical decisions (ex. aggressive,passive) differ according to patient characteristics. Unit of Measure: Audio recordings of office visits, will be transcribed, deidentified, and coded.
1 secondary outcome
Physician Communication Moderators (Sex,Class)
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2018.
- Derived from this study: PubMed 30632104Shields CG, Griggs JJ, Fiscella K, Elias CM, Christ SL, Colbert J, Henry SG, Hoh BG, Hunte HER, Marshall M, Mohile SG, Plumb S, Tejani MA, Venuti A, Epstein RM. The Influence of Patient Race and Activation on Pain Management in Advanced Lung Cancer: a Randomized Field Experiment. J Gen Intern Med. 2019 Mar;34(3):435-442. doi: 10.1007/s11606-018-4785-z. Epub 2019 Jan 10.
- Derived from this study: PubMed 28841847Elias CM, Shields CG, Griggs JJ, Fiscella K, Christ SL, Colbert J, Henry SG, Hoh BG, Hunte HER, Marshall M, Mohile SG, Plumb S, Tejani MA, Venuti A, Epstein RM. The social and behavioral influences (SBI) study: study design and rationale for studying the effects of race and activation on cancer pain management. BMC Cancer. 2017 Aug 25;17(1):575. doi: 10.1186/s12885-017-3564-2.
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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.
Ronald Epstein, MD principal investigator
University of Rochester
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 Communication, run by University of Rochester 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 2 inclusion and 1 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 Mar 2018. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Physicians Communication Style (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01501006, which also lists 2 linked publications.
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 Mar 2018.