Pneumonia, PneumococcalNCT05799976
Text Message-Based Nudges Prior to Primary Care Visits to Increase Care Gap Closure
A study testing Text message nudge in people with Pneumonia, Pneumococcal and Diabetes Mellitus, run by Mitesh Patel at 1 site in United States.
Trial summary
Primary care visits are a key aspect of clinical care focused on helping patients to close care gaps related to preventive care such as vaccination, diabetes testing, statin therapy and cancer screening. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pneumonia, Pneumococcal, Diabetes Mellitus, Breast Cancer
- What is being tested?
- Text message nudge
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29,334 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Sep 2023to 9 Feb 2024
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 or older
- Have documented consent to communicate electronically
- Have a visit scheduled with a primary care practice
- Have at least one open care gap among those in the intervention
Who cannot join
- No phone number on file to send text messages
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pragmatic Randomized Intervention Using Text Messages Prior to Primary Care Visits to Encourage Care Gap Closure: The PRIME Randomized Clinical Trial
Primary care visits are a key aspect of clinical care focused on helping patients to close care gaps related to preventive care such as vaccination, diabetes testing, statin therapy and cancer screening. However, less than 50% of care gaps are closed during these visits and new approaches are needed to prime patients for a discussion during these visits. In this study, the study team will evaluate a health system initiative that uses text messaging to patients in days preceding a primary care visit to prime patients to be amenable to ordering of vaccination, diabetes testing, cancer screening, and statin prescribing.
Read the detailed description
The United States Preventive Services Task Force has recommended tests and treatments for vaccination, diabetes testing, statin therapy, and cancer screening. These preventive services have been demonstrated to reduce illness and improve quality of care. Yet, more than 50% of open care gaps go unaddressed during primary care visits.
Nudges are subtle changes to the way information is framed or choices are offered that can have a significant impact on behavior. In a previous randomized clinical trial, text messages sent to patients prior to primary care visits increased vaccination by up to 11% relative to control. The most effective message told patients the influenza vaccine was "reserved for you," and sent two text messages to patients in the 3 days preceding a primary care appointment.
- Being tested
- Text message nudge
- Medical subject headings
- Pneumonia, Pneumococcal, Diabetes Mellitus, Breast Neoplasms, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Text message nudgeBehavioural
The text message nudge will be sent to patients 3 days and 1 day prior to a visit with the primary care practices and notify them of up to 3 care gaps based on electronic health record data. Care gaps will be selected based on availability and ranked in this order: influenza vaccination, pneumococcal vaccination, breast cancer screening, colorectal cancer screening, hemoglobin A1 testing, or statin therapy.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | No intervention | This is a group will serve as usual care and have no intervention during the study period |
| Text Message Group | Experimental | This group of primary care practices will be randomized to have the text message intervention Receives: Behavioral: Text message nudge |
What is being measured
The primary outcome is the main question the study is designed to answer.
Care gap order rate
The proportion of open care gaps that have a test or treatment ordered to address them
Measured: By the end of the day of the primary care visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2023
- Study start5 Sep 2023
- Primary completion9 Nov 2023
- Study completion9 Feb 2024
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 Pneumonia, PneumococcalStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study will use a randomized clinical trial to evaluate a health system initiative to improve care gap closure. We will randomly assign primary care practices that use AthenaClinicals electronic health record at the following locations at Ascension's health system: Alabama-Birmingham, Kansas-Wichita, Tennessee-Nashville, Texas-Austin, and Texas-Waco. These practices will have the opportunity to opt-out from the program before randomization occurs.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 29,334 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mitesh Patel
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor-investigator, Mitesh Patel, Ascension Health
- Investigators
- Mitesh Patel, MD, Principal investigator, Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05799976
- Sponsor's protocol ID
- RIN20230039
- Status last verified
- Apr 2024
- First submitted
- 22 Mar 2023
- Last updated
- 25 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Has patient information that we are not approved to share
Publications
Milkman KL, Patel MS, Gandhi L, Graci HN, Gromet DM, Ho H, Kay JS, Lee TW, Akinola M, Beshears J, Bogard JE, Buttenheim A, Chabris CF, Chapman GB, Choi JJ, Dai H, Fox CR, Goren A, Hilchey MD, Hmurovic J, John LK, Karlan D, Kim M, Laibson D, Lamberton C, Madrian BC, Meyer MN, Modanu M, Nam J, Rogers T, Rondina R, Saccardo S, Shermohammed M, Soman D, Sparks J, Warren C, Weber M, Berman R, Evans CN, Snider CK, Tsukayama E, Van den Bulte C, Volpp KG, Duckworth AL. A megastudy of text-based nudges encouraging patients to get vaccinated at an upcoming doctor's appointment. Proc Natl Acad Sci U S A. 2021 May 18;118(20):e2101165118. doi: 10.1073/pnas.2101165118.
PubMed 33926993Patel MS, Aloia TA, Shoemaker AG, Fakih MG, Masoudi FA, Smith L, Rosenzweig E, Chaiyachati KH, Conrad BN, Bandreddi J, Fogel RI. A Digital Care Plan Nudge to Improve Primary Care Outcomes. NEJM Evid. 2025 Jun;4(6):EVIDoa2400419. doi: 10.1056/EVIDoa2400419. Epub 2025 May 27.
PubMed 40423396
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pragmatic Randomized Intervention Using Text Messages Prior to Primary Care Visits to Encourage Care Gap Closure: The PRIME Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05799976
- Acronym / sponsor ID
- RIN20230039
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29,334 participants (actual)
- Lead sponsor
- Mitesh PatelIndustry (pharma, biotech, devices)
- Study start
- 5 Sep 2023 (actual)
- Primary completion
- 9 Nov 2023 (actual)
- Study completion
- 9 Feb 2024 (actual)
- First posted
- 5 Apr 2023 (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.
Primary care visits are a key aspect of clinical care focused on helping patients to close care gaps related to preventive care such as vaccination, diabetes testing, statin therapy and cancer screening. However, less than 50% of care gaps are closed during these visits and new approaches are needed to prime patients for a discussion during these visits. In this study, the study team will evaluate a health system initiative that uses text messaging to patients in days preceding a primary care visit to prime patients to be amenable to ordering of vaccination, diabetes testing, cancer screening, and statin prescribing.
Detailed description
The United States Preventive Services Task Force has recommended tests and treatments for vaccination, diabetes testing, statin therapy, and cancer screening. These preventive services have been demonstrated to reduce illness and improve quality of care. Yet, more than 50% of open care gaps go unaddressed during primary care visits.
Nudges are subtle changes to the way information is framed or choices are offered that can have a significant impact on behavior. In a previous randomized clinical trial, text messages sent to patients prior to primary care visits increased vaccination by up to 11% relative to control. The most effective message told patients the influenza vaccine was "reserved for you," and sent two text messages to patients in the 3 days preceding a primary care appointment.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This study will use a randomized clinical trial to evaluate a health system initiative to improve care gap closure. We will randomly assign primary care practices that use AthenaClinicals electronic health record at the following locations at Ascension's health system: Alabama-Birmingham, Kansas-Wichita, Tennessee-Nashville, Texas-Austin, and Texas-Waco. These practices will have the opportunity to opt-out from the program before randomization occurs.
| Arm | Type | Receives |
|---|---|---|
| Usual Care | No intervention | –This is a group will serve as usual care and have no intervention during the study period |
| Text Message Group | Experimental | Behavioral: Text message nudgeThis group of primary care practices will be randomized to have the text message intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 or older
- Have documented consent to communicate electronically
- Have a visit scheduled with a primary care practice
- Have at least one open care gap among those in the intervention
Key exclusion criteria (1 listed)
- No phone number on file to send text messages
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 |
|---|---|---|
| Text message nudgeThe text message nudge will be sent to patients 3 days and 1 day prior to a visit with the primary care practices and notify them of up to 3 care gaps based on electronic health record data. Care gaps will be selected based on availability and ranked in this order: influenza vaccination, pneumococcal vaccination, breast cancer screening, colorectal cancer screening, hemoglobin A1 testing, or statin therapy. | Behavioural | Text Message Group |
Primary outcome
Care gap order rate
Time frame: By the end of the day of the primary care visit
The proportion of open care gaps that have a test or treatment ordered to address them
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 25 Apr 2024.
- Background: PubMed 33926993Milkman KL, Patel MS, Gandhi L, Graci HN, Gromet DM, Ho H, Kay JS, Lee TW, Akinola M, Beshears J, Bogard JE, Buttenheim A, Chabris CF, Chapman GB, Choi JJ, Dai H, Fox CR, Goren A, Hilchey MD, Hmurovic J, John LK, Karlan D, Kim M, Laibson D, Lamberton C, Madrian BC, Meyer MN, Modanu M, Nam J, Rogers T, Rondina R, Saccardo S, Shermohammed M, Soman D, Sparks J, Warren C, Weber M, Berman R, Evans CN, Snider CK, Tsukayama E, Van den Bulte C, Volpp KG, Duckworth AL. A megastudy of text-based nudges encouraging patients to get vaccinated at an upcoming doctor's appointment. Proc Natl Acad Sci U S A. 2021 May 18;118(20):e2101165118. doi: 10.1073/pnas.2101165118.
- Derived from this study: PubMed 40423396Patel MS, Aloia TA, Shoemaker AG, Fakih MG, Masoudi FA, Smith L, Rosenzweig E, Chaiyachati KH, Conrad BN, Bandreddi J, Fogel RI. A Digital Care Plan Nudge to Improve Primary Care Outcomes. NEJM Evid. 2025 Jun;4(6):EVIDoa2400419. doi: 10.1056/EVIDoa2400419. Epub 2025 May 27.
- Individual participant dataSharing planned: No. Has patient information that we are not approved to share
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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.
Mitesh Patel, MD principal investigator
Principal Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Text message nudge in people with Pneumonia, Pneumococcal and Diabetes Mellitus, run by Mitesh Patel 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 4 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 25 Apr 2024. 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?
Care gap order rate (time frame: By the end of the day of the primary care 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 NCT05799976, 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 25 Apr 2024.