Smoking, TobaccoNCT05172219
Evaluation of Electronic Portal Messaging and Embedded Asynchronous Care on Physician-Assisted Smoking Quit Attempts
A study testing Physician Sent Outreach with Embedded Asynchronous Care in Portal Message, Physician Sent Outreach without Embedded Asynchronous Care in Portal Message and System Sent Outreach with Embedded Asynchronous Care in Portal Message in people with Smoking, Tobacco, run by Oklahoma State University Center for Health Sciences at 1 site in United States.
Trial summary
Among 10 PCPs, 200 adult smokers with an active patient portal who had been seen by a PCP within 12 months were randomly selected and randomly assigned to one of four conditions to compare the quit attempts of patients sent electronic outreach with and without asynchronous care link and to compare the quit attempts of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking, Tobacco
- What is being tested?
- Physician Sent Outreach with Embedded Asynchronous Care in Portal Message, Physician Sent Outreach without Embedded Asynchronous Care in Portal Message and System Sent Outreach with Embedded Asynchronous Care in Portal Message
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jan 2020to 31 Dec 2020
- 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
- Adults aged 18 years and older who were designated as a smoker in the EHR who had at least one face-to-face visit with their PCP in the prior 12 months and had a patient portal account
- To ensure equal representation across the 10 physicians, we randomly selected 20 patients under each physician to serve in the sample.
Who cannot join
- Patients were excluded if they no longer see the PCP, had a diagnosis for which the outreach program would be insensitive (e.g., lung cancer), previously expressed not wanting smoking cessation counseling, or were no longer a smoker.
- (Patients were post-hoc excluded if EHR indicated that they had received smoking cessation treatment 60 days prior to portal message intervention.)
Trial locations and contacts
1 site in 1 country.
United States1 site
Oklahoma State University Center for Health Sciences
Tulsa, Oklahoma, 74107
About this study
Official title: A Quality Improvement Randomized Clinical Trial to Evaluate Electronic Portal Messaging, Embedded Asynchronous Care and Physician Versus System as Message Sender on Physician-Assisted Smoking Quit Attempts of Primary Care, Adult Patients
Among 10 PCPs, 200 adult smokers with an active patient portal who had been seen by a PCP within 12 months were randomly selected and randomly assigned to one of four conditions to compare the quit attempts of patients sent electronic outreach with and without asynchronous care link and to compare the quit attempts of patients who recieved the portal message from PCP or the health system.
Read the detailed description
The investigators compared the effects of four technology-based smoking cessation messaging strategies on quit attempts by smokers identified in the health system. Specifically, investigators used a fully crossed between-subjects 2 (link to survey on smoking cessation guide: yes/no) × 2 (message source: PCP-generated vs. health system-generated) experimental design to which participants were randomly assigned to one of four intervention groups using a computerized random number generator:
- Group 1 was sent the message from their physician without a link to a survey;
- Group 2 was sent the message from their physician with the link to the survey (which constitutes the asynchronous care);
- Group 3 was sent the message from the health system without a link to the survey; and
- Group 4 was sent the message from the health system with the link to the survey (which constitutes the asynchronous care).
Electronic outreach was a message sent to patients via the patient portal. It encouraged a quit attempt; offered physician assistance; advised the patient on medication use to control cravings; and offered counseling support in the form of a Quitline. Patients in Groups 1 and 3 were invited to schedule an in-person appointment with their PCP if they wanted help. Patients in Groups 2 and 4 received the message with an embedded link to Tobacco Cessation Survey to receive PCP assistance asynchronously. If patients clicked through to access the survey, they answered 17 questions, confirming smoking status, reporting safety information for medication selection, describing prior quit attempts and sharing treatment preferences. The intervention was "asynchronous" because it did not involve direct, simultaneous interaction (e.g., face-to-face, chat, video conference) between the physician and the patient. After patient responses were submitted, they were stored and forwarded to their PCP. Physicians communicated the care plan and instructed patients via the portal message. If the plan included medication, a prescription was sent to the patient's EHR-documented preferred pharmacy without an in-person visit.
- Conditions
- Smoking, Tobacco
- Being tested
- Physician Sent Outreach with Embedded Asynchronous Care in Portal Message, Physician Sent Outreach without Embedded Asynchronous Care in Portal Message, System Sent Outreach with Embedded Asynchronous Care in Portal Message, System Sent Outreach without Embedded Asynchronous Care in Portal Message
- Keywords
- Smoking Quit Attempts, Quality Improvement, Asynchronous Care, Electronic Messaging
- Medical subject headings
- Tobacco Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physician Sent Outreach with Embedded Asynchronous Care in Portal MessageBehavioural
Also called PSL
PCPs sent a portal message encouraging a quit attempt embedded a link to asynchronous care within a portal message encouraging a quit attempt in order to compare EMR-documented, physician-assisted quit attempts to those who received messages without the link 30 days after messages were sent.
Physician Sent Outreach without Embedded Asynchronous Care in Portal MessageBehavioural
Also called PNSL
Physician sent a portal message encouraging a quit attempt without a link to asynchronous care within a portal message encouraging a quit attempt in order to compare EMR-documented, physician-assisted quit attempts to those who received messages without the link 30 days after messages were sent.
System Sent Outreach with Embedded Asynchronous Care in Portal MessageBehavioural
Also called SSL
Health System sent a portal message encouraging a quit attempt embedded a link to asynchronous care within a portal message encouraging a quit attempt in order to compare EMR-documented, physician-assisted quit attempts to those who received messages without the link 30 days after messages were sent.
System Sent Outreach without Embedded Asynchronous Care in Portal MessageBehavioural
Also called SNSL
Health System sent a portal message encouraging a quit attempt without a link to asynchronous care within a portal message encouraging a quit attempt in order to compare EMR-documented, physician-assisted quit attempts to those who received messages without the link 30 days after messages were sent. Half of the messages came from the patient's PCP and the other half came from the health system to determine if communication from a patient's physician was associated with more quit attempts.
| Study group | Role | What they receive |
|---|---|---|
| Message Type PNSL: Physician sender, No Survey Link | Active comparator | In this arm, the Physician is message sender and the message does not include a link to a survey that initiates asynchronous care. Receives: Behavioral: Physician Sent Outreach without Embedded Asynchronous Care in Portal Message |
| Message Type PSL: Physician sender, Survey Link | Active comparator | In this arm, the Physician is message sender and the message does include a link to a survey that initiates asynchronous care. Receives: Behavioral: Physician Sent Outreach with Embedded Asynchronous Care in Portal Message |
| Message Type SNSL: System sender, No Survey Link | Active comparator | In this arm, the Health System is message sender and the message does not include a link to a survey that initiates asynchronous care. Receives: Behavioral: System Sent Outreach without Embedded Asynchronous Care in Portal Message |
| Message Type SSL: System sender, Survey Link | Active comparator | In this arm, the Health System is message sender and the message does include a link to a survey that initiates asynchronous care. Receives: Behavioral: System Sent Outreach with Embedded Asynchronous Care in Portal Message |
What is being measured
The primary outcome is the main question the study is designed to answer.
Smoking Quit Attempt
Smoking Quit Attempt documented in the EMR
Measured: 30 days after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2021
- Study start13 Jan 2020
- Primary completion24 Feb 2020
- Study completion31 Dec 2020
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 Smoking, TobaccoStudies 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
- The model was a 2 (link to survey) × 2 (message source) experimental design; therefore, we had two factors that created four treatment conditions.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oklahoma State University Center for Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marjorie A Erdmann, MS, Principal investigator, Oklahoma State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05172219
- Sponsor's protocol ID
- 2020031
- Status last verified
- Dec 2021
- First submitted
- 30 Nov 2021
- Last updated
- 29 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Erdmann M, Edwards B, Adewumi MT. Effect of Electronic Portal Messaging With Embedded Asynchronous Care on Physician-Assisted Smoking Cessation Attempts: A Randomized Clinical Trial. JAMA Netw Open. 2022 Feb 1;5(2):e220348. doi: 10.1001/jamanetworkopen.2022.0348.
PubMed 35226082
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Quality Improvement Randomized Clinical Trial to Evaluate Electronic Portal Messaging, Embedded Asynchronous Care and Physician Versus System as Message Sender on Physician-Assisted Smoking Quit Attempts of Primary Care, Adult Patients
- ClinicalTrials.gov ID
- NCT05172219
- Acronym / sponsor ID
- 2020031
- Conditions
- Smoking, Tobacco
- Keywords
- Smoking Quit Attempts, Quality Improvement, Asynchronous Care, Electronic Messaging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Oklahoma State University Center for Health SciencesUniversity, hospital or other
- Study start
- 13 Jan 2020 (actual)
- Primary completion
- 24 Feb 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 29 Dec 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.
Among 10 PCPs, 200 adult smokers with an active patient portal who had been seen by a PCP within 12 months were randomly selected and randomly assigned to one of four conditions to compare the quit attempts of patients sent electronic outreach with and without asynchronous care link and to compare the quit attempts of patients who recieved the portal message from PCP or the health system.
Detailed description
The investigators compared the effects of four technology-based smoking cessation messaging strategies on quit attempts by smokers identified in the health system. Specifically, investigators used a fully crossed between-subjects 2 (link to survey on smoking cessation guide: yes/no) × 2 (message source: PCP-generated vs. health system-generated) experimental design to which participants were randomly assigned to one of four intervention groups using a computerized random number generator:
- Group 1 was sent the message from their physician without a link to a survey;
- Group 2 was sent the message from their physician with the link to the survey (which constitutes the asynchronous care);
- Group 3 was sent the message from the health system without a link to the survey; and
- Group 4 was sent the message from the health system with the link to the survey (which constitutes the asynchronous care).
Electronic outreach was a message sent to patients via the patient portal. It encouraged a quit attempt; offered physician assistance; advised the patient on medication use to control cravings; and offered counseling support in the form of a Quitline. Patients in Groups 1 and 3 were invited to schedule an in-person appointment with their PCP if they wanted help. Patients in Groups 2 and 4 received the message with an embedded link to Tobacco Cessation Survey to receive PCP assistance asynchronously. If patients clicked through to access the survey, they answered 17 questions, confirming smoking status, reporting safety information for medication selection, describing prior quit attempts and sharing treatment preferences. The intervention was "asynchronous" because it did not involve direct, simultaneous interaction (e.g., face-to-face, chat, video conference) between the physician and the patient. After patient responses were submitted, they were stored and forwarded to their PCP. Physicians communicated the care plan and instructed patients via the portal message. If the plan included medication, a prescription was sent to the patient's EHR-documented preferred pharmacy without an in-person visit.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- The model was a 2 (link to survey) × 2 (message source) experimental design; therefore, we had two factors that created four treatment conditions.
| Arm | Type | Receives |
|---|---|---|
| Message Type PNSL: Physician sender, No Survey Link | Active comparator | Behavioral: Physician Sent Outreach without Embedded Asynchronous Care in Portal MessageIn this arm, the Physician is message sender and the message does not include a link to a survey that initiates asynchronous care. |
| Message Type PSL: Physician sender, Survey Link | Active comparator | Behavioral: Physician Sent Outreach with Embedded Asynchronous Care in Portal MessageIn this arm, the Physician is message sender and the message does include a link to a survey that initiates asynchronous care. |
| Message Type SNSL: System sender, No Survey Link | Active comparator | Behavioral: System Sent Outreach without Embedded Asynchronous Care in Portal MessageIn this arm, the Health System is message sender and the message does not include a link to a survey that initiates asynchronous care. |
| Message Type SSL: System sender, Survey Link | Active comparator | Behavioral: System Sent Outreach with Embedded Asynchronous Care in Portal MessageIn this arm, the Health System is message sender and the message does include a link to a survey that initiates asynchronous care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults aged 18 years and older who were designated as a smoker in the EHR who had at least one face-to-face visit with their PCP in the prior 12 months and had a patient portal account
- To ensure equal representation across the 10 physicians, we randomly selected 20 patients under each physician to serve in the sample.
Key exclusion criteria (2 listed)
- Patients were excluded if they no longer see the PCP, had a diagnosis for which the outreach program would be insensitive (e.g., lung cancer), previously expressed not wanting smoking cessation counseling, or were no longer a smoker.
- (Patients were post-hoc excluded if EHR indicated that they had received smoking cessation treatment 60 days prior to portal message intervention.)
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 |
|---|---|---|
| Physician Sent Outreach with Embedded Asynchronous Care in Portal MessageAlso: PSLPCPs sent a portal message encouraging a quit attempt embedded a link to asynchronous care within a portal message encouraging a quit attempt in order to compare EMR-documented, physician-assisted quit attempts to those who received messages without the link 30 days after messages were sent. | Behavioural | Message Type PSL: Physician sender, Survey Link |
| Physician Sent Outreach without Embedded Asynchronous Care in Portal MessageAlso: PNSLPhysician sent a portal message encouraging a quit attempt without a link to asynchronous care within a portal message encouraging a quit attempt in order to compare EMR-documented, physician-assisted quit attempts to those who received messages without the link 30 days after messages were sent. | Behavioural | Message Type PNSL: Physician sender, No Survey Link |
| System Sent Outreach with Embedded Asynchronous Care in Portal MessageAlso: SSLHealth System sent a portal message encouraging a quit attempt embedded a link to asynchronous care within a portal message encouraging a quit attempt in order to compare EMR-documented, physician-assisted quit attempts to those who received messages without the link 30 days after messages were sent. | Behavioural | Message Type SSL: System sender, Survey Link |
| System Sent Outreach without Embedded Asynchronous Care in Portal MessageAlso: SNSLHealth System sent a portal message encouraging a quit attempt without a link to asynchronous care within a portal message encouraging a quit attempt in order to compare EMR-documented, physician-assisted quit attempts to those who received messages without the link 30 days after messages were sent. Half of the messages came from the patient's PCP and the other half came from the health system to determine if communication from a patient's physician was associated with more quit attempts. | Behavioural | Message Type SNSL: System sender, No Survey Link |
Primary outcome
Smoking Quit Attempt
Time frame: 30 days after intervention
Smoking Quit Attempt documented in the EMR
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 29 Dec 2021.
- Derived from this study: PubMed 35226082Erdmann M, Edwards B, Adewumi MT. Effect of Electronic Portal Messaging With Embedded Asynchronous Care on Physician-Assisted Smoking Cessation Attempts: A Randomized Clinical Trial. JAMA Netw Open. 2022 Feb 1;5(2):e220348. doi: 10.1001/jamanetworkopen.2022.0348.
- Individual participant dataSharing planned: No
Related trials for Smoking, Tobacco
Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Enrolling by invitationObservational study
Using Smartwatches to Monitor Smoking in Real-life Situations
Smoking
Not yet recruitingObservational study
PROMETHEE: A Shared Interregional Tele-Tobacco Cessation Platform Embedded Within the IMPULSION Lung Cancer Screening Program
Smoking Cessation, Lung Cancer Screening
Recruiting
Effectiveness of Volitional Help Sheets as an Adjunct to Treatment to Promote Behavior Change: A Pilot Study on Smoking
Tobacco Dependence
Not yet recruiting
Impacto 2.0: Mobile Smoking Cessation Across Texas
Cigarette Smoking, Smoking Cessation
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.
Marjorie A Erdmann, MS principal investigator
Oklahoma State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physician Sent Outreach with Embedded Asynchronous Care in Portal Message, Physician Sent Outreach without Embedded Asynchronous Care in Portal Message and System Sent Outreach with Embedded Asynchronous Care in Portal Message in people with Smoking, Tobacco, run by Oklahoma State University Center for Health Sciences 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 2 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 29 Dec 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?
Smoking Quit Attempt (time frame: 30 days after intervention). 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 NCT05172219, 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 29 Dec 2021.