- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05172219
Evaluation of Electronic Portal Messaging and Embedded Asynchronous Care on Physician-Assisted Smoking Quit Attempts
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
Study Overview
Status
Conditions
Intervention / Treatment
- Behavioral: Physician Sent Outreach without Embedded Asynchronous Care in Portal Message
- Behavioral: Physician Sent Outreach with Embedded Asynchronous Care in Portal Message
- Behavioral: System Sent Outreach without Embedded Asynchronous Care in Portal Message
- Behavioral: System Sent Outreach with Embedded Asynchronous Care in Portal Message
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Oklahoma
-
Tulsa, Oklahoma, United States, 74107
- Oklahoma State University Center for Health Sciences
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Message Type PNSL: Physician sender, No Survey Link
In this arm, the Physician is message sender and the message does not include a link to a survey that initiates asynchronous care.
|
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.
Other Names:
|
|
Active Comparator: Message Type PSL: Physician sender, Survey Link
In this arm, the Physician is message sender and the message does include a link to a survey that initiates asynchronous care.
|
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.
Other Names:
|
|
Active Comparator: Message Type SNSL: System sender, No Survey Link
In this arm, the Health System is message sender and the message does not include a link to a survey that initiates asynchronous care.
|
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.
Other Names:
|
|
Active Comparator: Message Type SSL: System sender, Survey Link
In this arm, the Health System is message sender and the message does include a link to a survey that initiates asynchronous care.
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Smoking Quit Attempt
Time Frame: 30 days after intervention
|
Smoking Quit Attempt documented in the EMR
|
30 days after intervention
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Physician Perceptions of Electronic Outreach Intervention
Time Frame: 6 months after intervention
|
Physician perceptions of the electronic outreach intervention were measured using a 5-point scale to assess perceptions of workload, comfort of providing medication from survey information, and further interest in the program.
|
6 months after intervention
|
Collaborators and Investigators
Investigators
- Principal Investigator: Marjorie A Erdmann, MS, Oklahoma State University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2020031
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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