VaccinationNCT05096026
Effect of Electronic and Mail Outreach From Primary Care Physicians for COVID-19 Vaccination Among Elderly Patients
A study testing Standard PCP Outreach and Culturally Tailored PCP Outreach in people with Vaccination, run by Kaiser Permanente at 1 site in United States.
Trial summary
This randomized controlled trial tested the effect of culturally tailored and standard electronic secure messages and mailings from patients' primary care physicians to encourage COVID-19 vaccination among adults aged 65 and older. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Vaccination
- What is being tested?
- Standard PCP Outreach and Culturally Tailored PCP Outreach
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8,287 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Mar 2021to 31 Aug 2021
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- -
Who cannot join
- Received COVID-19 vaccine prior to Study Outreach 1.
Trial locations and contacts
1 site in 1 country.
United States1 site
Kaiser Permanente Northern California
Oakland, California, 94612
About this study
This randomized controlled trial tested the effect of culturally tailored and standard electronic secure messages and mailings from patients' primary care physicians to encourage COVID-19 vaccination among adults aged 65 and older.
Read the detailed description
This randomized controlled trial tested the effect of culturally tailored and standard electronic secure messages and mailings from patients' primary care physicians to encourage COVID-19 vaccination among adults aged 65 and older. Patients who had not received a COVID-19 vaccination or appointment after previous outreach attempts were randomized to receive (a) an electronic secure message and/or mail outreach from their PCP, (b) similar outreach with additional culturally tailored content, or (c) usual care. The primary outcome was receipt of COVID-19 vaccination during the 8 weeks after the initial study outreach date.
- Conditions
- Vaccination
- Being tested
- Standard PCP Outreach, Culturally Tailored PCP Outreach
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard PCP OutreachBehavioural
These patients were sent two study outreach messages. Study Outreach 1 was an electronic secure message sent on behalf of the PCP, encouraging COVID-19 vaccination and designed based on behavioral science principles. Letters were sent to patients who had not signed up for the electronic health record portal. Study Outreach 2 was a postcard sent to all patients who had not been vaccinated or made an appointment by four weeks after Study Outreach 1.
Culturally Tailored PCP OutreachBehavioural
These patients were sent messages similar to those in Standard PCP Outreach, but with additional culturally tailored content and photos.
| Study group | Role | What they receive |
|---|---|---|
| Standard PCP Outreach | Experimental | These patients were sent standard outreach messages to promote COVID-19 vaccination. Receives: Behavioral: Standard PCP Outreach |
| Culturally Tailored PCP Outreach | Experimental | These patients were sent messages similar to those in the Standard PCP Outreach Group, but with additional culturally tailored content. Receives: Behavioral: Culturally Tailored PCP Outreach |
| Usual Care | No intervention | These patients were not sent the above study outreach messages, but may have received other messages from their local medical centers or counties. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Days to COVID-19 vaccination
Days to COVID-19 vaccination
Measured: During the 8 weeks after Study Outreach 1 was sent
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2021
- Study start29 Mar 2021
- Primary completion20 May 2021
- Study completion31 Aug 2021
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 VaccinationStudies of the same condition, open and under way.
- More trials run by Kaiser PermanenteThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 8,287 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tracy Lieu, MD, Principal investigator, The Permanente Medical Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05096026
- Sponsor's protocol ID
- RDO KPNC 21-044
- Status last verified
- Oct 2021
- First submitted
- 25 Oct 2021
- Last updated
- 27 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified data will be shared on submission of a protocol approved by the Kaiser Permanente Northern California Institutional Review Board or Research Determination Official, and contingent on appropriate data sharing agreement being completed.
Publications
Lieu TA, Elkin EP, Escobar PR, Finn L, Klein NP, Durojaiye C, Prausnitz S, Quesenberry CP, Sawyer D, Teran S, Goler N, Parodi SM, Chen YI. Effect of Electronic and Mail Outreach From Primary Care Physicians for COVID-19 Vaccination of Black and Latino Older Adults: A Randomized Clinical Trial. JAMA Netw Open. 2022 Jun 1;5(6):e2217004. doi: 10.1001/jamanetworkopen.2022.17004.
PubMed 35713906
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Electronic and Mail Outreach From Primary Care Physicians for COVID-19 Vaccination Among Elderly Patients
- ClinicalTrials.gov ID
- NCT05096026
- Acronym / sponsor ID
- RDO KPNC 21-044
- Conditions
- Vaccination
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8,287 participants (actual)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Study start
- 29 Mar 2021 (actual)
- Primary completion
- 20 May 2021 (actual)
- Study completion
- 31 Aug 2021 (actual)
- First posted
- 27 Oct 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.
This randomized controlled trial tested the effect of culturally tailored and standard electronic secure messages and mailings from patients' primary care physicians to encourage COVID-19 vaccination among adults aged 65 and older.
Detailed description
This randomized controlled trial tested the effect of culturally tailored and standard electronic secure messages and mailings from patients' primary care physicians to encourage COVID-19 vaccination among adults aged 65 and older. Patients who had not received a COVID-19 vaccination or appointment after previous outreach attempts were randomized to receive (a) an electronic secure message and/or mail outreach from their PCP, (b) similar outreach with additional culturally tailored content, or (c) usual care. The primary outcome was receipt of COVID-19 vaccination during the 8 weeks after the initial study outreach date.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard PCP Outreach | Experimental | Behavioral: Standard PCP OutreachThese patients were sent standard outreach messages to promote COVID-19 vaccination. |
| Culturally Tailored PCP Outreach | Experimental | Behavioral: Culturally Tailored PCP OutreachThese patients were sent messages similar to those in the Standard PCP Outreach Group, but with additional culturally tailored content. |
| Usual Care | No intervention | –These patients were not sent the above study outreach messages, but may have received other messages from their local medical centers or counties. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- -
Key exclusion criteria (1 listed)
- Received COVID-19 vaccine prior to Study Outreach 1.
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 |
|---|---|---|
| Standard PCP OutreachThese patients were sent two study outreach messages. Study Outreach 1 was an electronic secure message sent on behalf of the PCP, encouraging COVID-19 vaccination and designed based on behavioral science principles. Letters were sent to patients who had not signed up for the electronic health record portal. Study Outreach 2 was a postcard sent to all patients who had not been vaccinated or made an appointment by four weeks after Study Outreach 1. | Behavioural | Standard PCP Outreach |
| Culturally Tailored PCP OutreachThese patients were sent messages similar to those in Standard PCP Outreach, but with additional culturally tailored content and photos. | Behavioural | Culturally Tailored PCP Outreach |
Primary outcome
Days to COVID-19 vaccination
Time frame: During the 8 weeks after Study Outreach 1 was sent
Days to COVID-19 vaccination
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 27 Oct 2021.
- Derived from this study: PubMed 35713906Lieu TA, Elkin EP, Escobar PR, Finn L, Klein NP, Durojaiye C, Prausnitz S, Quesenberry CP, Sawyer D, Teran S, Goler N, Parodi SM, Chen YI. Effect of Electronic and Mail Outreach From Primary Care Physicians for COVID-19 Vaccination of Black and Latino Older Adults: A Randomized Clinical Trial. JAMA Netw Open. 2022 Jun 1;5(6):e2217004. doi: 10.1001/jamanetworkopen.2022.17004.
- Individual participant dataSharing planned: Yes. Deidentified data will be shared on submission of a protocol approved by the Kaiser Permanente Northern California Institutional Review Board or Research Determination Official, and contingent on appropriate data sharing agreement being completed.
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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.
Tracy Lieu, MD principal investigator
The Permanente Medical Group
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard PCP Outreach and Culturally Tailored PCP Outreach in people with Vaccination, run by Kaiser Permanente 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 1 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 27 Oct 2021. 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?
Days to COVID-19 vaccination (time frame: During the 8 weeks after Study Outreach 1 was sent). 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 NCT05096026, 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 27 Oct 2021.