Health Knowledge, Attitudes, PracticeNCT04902664
Shared Decision-making on Medical Tests and Care Cascades
A study testing Patient education materials, Physician peer-comparison email and Physician education materials in people with Health Knowledge, Attitudes, Practice and Health Care Utilization, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
The purpose of this randomized controlled trial is to evaluate the impact of patient and provider facing educational materials and peer comparison on medical testing conversations during annual physicals. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Health Knowledge, Attitudes, Practice, Health Care Utilization
- What is being tested?
- Patient education materials, Physician peer-comparison email and Physician education materials
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 329 participants
- Where
- 1 siteUnited States
- Study dates
- 24 May 2021to 29 Oct 2022
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary care physicians at Brigham and Women's Hospital
- In active practice
- Adults age 18 years old or older
- English-speaking
- Access to email
- Did not opt out of receiving research invitations from health system
- Patients of participating physicians
- Scheduled annual physical during the study period
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02120
About this study
Official title: A Multi-pronged Intervention to Initiate Shared Decision-making on Medical Tests and Care Cascades in the Primary Care Setting
The purpose of this randomized controlled trial is to evaluate the impact of patient and provider facing educational materials and peer comparison on medical testing conversations during annual physicals. The investigators hypothesize that education materials and peer comparison will improve conversation quality about medical testing decisions.
Read the detailed description
Medical tests may show unexpected findings leading to additional tests, treatments, and visits that cost money and take time but may not have benefits. This is a prevalent issue with major consequences for patients and clinicians. Making informed decisions about when to order medical tests may help avoid unnecessary costs and worry. However, doctors don't always have detailed conversations about medical testing and there are patient gaps in knowledge. The investigators hypothesize that education materials and peer comparison to promote conversations about medical tests will improve conversation quality about medical testing decisions. The investigators have developed patient and provider-facing interventions to educate on and promote conversations about the uses and consequences of medical tests, and the investigators will test the impact of this just-in-time educational and peer comparison intervention on the likelihood of patients having productive conversations about medical tests. The effects of the intervention will be assessed using surveys before and after the study. This work has the potential to help patients feel more supported by their healthcare system, empower patients to participate in shared decision-making, and build trust between patients and clinicians.
- Being tested
- Patient education materials, Physician peer-comparison email, Physician education materials, General visit preparation materials
- Medical subject headings
- Behavior, Patient Acceptance of Health Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient education materialsBehavioural
Patients receive a text-message and email with educational materials about medical testing.
Physician peer-comparison emailBehavioural
Physicians receive an email with feedback on how they compare to their peers in aggregate on test ordering during annual physicals.
Physician education materialsBehavioural
Physicians receive reference materials on medical test interpretation and incidental findings.
General visit preparation materialsBehavioural
Patients receive a text-message and email with general visit preparation tips.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Experimental | Intervention arm physicians will receive an email with feedback on how they compare to their peers in aggregate on test ordering during annual physicals, along with physician-facing education materials. This email will be sent before each patient study visit for all patients in the study. Participating patients of intervention arm physicians will receive patient education materials one to two days before their study visit. Receives: Behavioral: Patient education materials; Behavioral: Physician peer-comparison email; Behavioral: Physician education materials |
| Control Arm | Placebo comparator | Control arm physicians receive an email with information on the general visit preparation tips that their patients will receive. Participating patients of control arm physicians will receive general visit preparation tips one to two days before their study visit. Receives: Behavioral: General visit preparation materials |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shared Decision-Making Process 4 Survey
Composite score of survey items completed by the patient after physician visit. Min 0, Max 4 (higher is better).
Measured: Within two weeks after visit
Secondary outcomes (5)
Presence of testing discussion
Binary measure from patient post-visit survey (present vs absent)
Measured: Within two weeks after visit
Satisfaction with testing discussion
Binary measure from patient post-visit survey (high vs low)
Measured: Within two weeks after visit
Discussion of next steps
Binary measure from patient post-visit survey (present vs absent)
Measured: Within two weeks after visit
Whether doctor explained tests in a way that was easy to understand
Binary measure from patient post-visit survey (yes completely vs yes a little or no)
Measured: Within two weeks after visit
Patient knowledge
Composite score of survey items from patient post-visit survey. Min 0, Max 4 (higher is better).
Measured: Within two weeks after visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2021
- Study start24 May 2021
- Primary completion6 Oct 2022
- Study completion29 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Health Knowledge, Attitudes, PracticeStudies of the same condition, open and under way.
- More trials run by Brigham and Women's 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 20 primary care physicians will be recruited and randomized to an intervention and a control arm. For each physician, we will recruit at least 10 of their patients with upcoming scheduled physicals. All included patients of intervention physicians will receive the intervention, and all included patients of control physicians will receive general patient visit prep materials.
- Masking
- None (open label)
- Enrolment
- 329 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- RAND, Robert Wood Johnson Foundation
- Responsible party
- Principal investigator, Ishani Ganguli MD, MPH, Brigham and Women's Hospital
- Investigators
- Ishani Ganguli, MD, MPH, Principal investigator, Brigham and Women's HospitalRobert S Rudin, PhD, Principal investigator, RAND
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04902664
- Sponsor's protocol ID
- 2020P001080
- Status last verified
- Nov 2022
- First submitted
- 21 May 2021
- Last updated
- 17 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ganguli I, Mulligan KL, Chant ED, Lipsitz S, Simmons L, Sepucha K, Rudin RS. Effect of a Peer Comparison and Educational Intervention on Medical Test Conversation Quality: A Randomized Clinical Trial. JAMA Netw Open. 2023 Nov 1;6(11):e2342464. doi: 10.1001/jamanetworkopen.2023.42464.
PubMed 37943557
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-pronged Intervention to Initiate Shared Decision-making on Medical Tests and Care Cascades in the Primary Care Setting
- ClinicalTrials.gov ID
- NCT04902664
- Acronym / sponsor ID
- 2020P001080
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 329 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- RAND, Robert Wood Johnson Foundation
- Study start
- 24 May 2021 (actual)
- Primary completion
- 6 Oct 2022 (actual)
- Study completion
- 29 Oct 2022 (actual)
- First posted
- 26 May 2021 (actual)
- 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 this randomized controlled trial is to evaluate the impact of patient and provider facing educational materials and peer comparison on medical testing conversations during annual physicals. The investigators hypothesize that education materials and peer comparison will improve conversation quality about medical testing decisions.
Detailed description
Medical tests may show unexpected findings leading to additional tests, treatments, and visits that cost money and take time but may not have benefits. This is a prevalent issue with major consequences for patients and clinicians. Making informed decisions about when to order medical tests may help avoid unnecessary costs and worry. However, doctors don't always have detailed conversations about medical testing and there are patient gaps in knowledge. The investigators hypothesize that education materials and peer comparison to promote conversations about medical tests will improve conversation quality about medical testing decisions. The investigators have developed patient and provider-facing interventions to educate on and promote conversations about the uses and consequences of medical tests, and the investigators will test the impact of this just-in-time educational and peer comparison intervention on the likelihood of patients having productive conversations about medical tests. The effects of the intervention will be assessed using surveys before and after the study. This work has the potential to help patients feel more supported by their healthcare system, empower patients to participate in shared decision-making, and build trust between patients and clinicians.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 20 primary care physicians will be recruited and randomized to an intervention and a control arm. For each physician, we will recruit at least 10 of their patients with upcoming scheduled physicals. All included patients of intervention physicians will receive the intervention, and all included patients of control physicians will receive general patient visit prep materials.
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Behavioral: Patient education materials, Behavioral: Physician peer-comparison email, Behavioral: Physician education materialsIntervention arm physicians will receive an email with feedback on how they compare to their peers in aggregate on test ordering during annual physicals, along with physician-facing education materials. This email will be sent before each patient study visit for all patients in the study. Participating patients of intervention arm physicians will receive patient education materials one to two days before their study visit. |
| Control Arm | Placebo comparator | Behavioral: General visit preparation materialsControl arm physicians receive an email with information on the general visit preparation tips that their patients will receive. Participating patients of control arm physicians will receive general visit preparation tips one to two days before their study visit. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Primary care physicians at Brigham and Women's Hospital
- In active practice
- Adults age 18 years old or older
- English-speaking
- Access to email
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient education materialsPatients receive a text-message and email with educational materials about medical testing. | Behavioural | Intervention Arm |
| Physician peer-comparison emailPhysicians receive an email with feedback on how they compare to their peers in aggregate on test ordering during annual physicals. | Behavioural | Intervention Arm |
| Physician education materialsPhysicians receive reference materials on medical test interpretation and incidental findings. | Behavioural | Intervention Arm |
| General visit preparation materialsPatients receive a text-message and email with general visit preparation tips. | Behavioural | Control Arm |
Primary outcome
Shared Decision-Making Process 4 Survey
Time frame: Within two weeks after visit
Composite score of survey items completed by the patient after physician visit. Min 0, Max 4 (higher is better).
5 secondary outcomes
Presence of testing discussion
Time frame: Within two weeks after visit
Satisfaction with testing discussion
Time frame: Within two weeks after visit
Discussion of next steps
Time frame: Within two weeks after visit
Whether doctor explained tests in a way that was easy to understand
Time frame: Within two weeks after visit
Patient knowledge
Time frame: Within two weeks after visit
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 17 Nov 2022.
- Derived from this study: PubMed 37943557Ganguli I, Mulligan KL, Chant ED, Lipsitz S, Simmons L, Sepucha K, Rudin RS. Effect of a Peer Comparison and Educational Intervention on Medical Test Conversation Quality: A Randomized Clinical Trial. JAMA Netw Open. 2023 Nov 1;6(11):e2342464. doi: 10.1001/jamanetworkopen.2023.42464.
- Individual participant dataSharing planned: No
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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.
Ishani Ganguli, MD, MPH principal investigator
Brigham and Women's Hospital
Robert S Rudin, PhD principal investigator
RAND
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient education materials, Physician peer-comparison email and Physician education materials in people with Health Knowledge, Attitudes, Practice and Health Care Utilization, run by Brigham and Women's 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 8 inclusion and 0 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 17 Nov 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. Some participants in this study may receive a placebo. 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?
Shared Decision-Making Process 4 Survey (time frame: Within two weeks after visit). 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 NCT04902664, which also lists 1 linked publication.
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 17 Nov 2022.