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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05172219
Other study ID # 2020031
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 13, 2020
Est. completion date December 31, 2020

Study information

Verified date December 2021
Source Oklahoma State University Center for Health Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 patients who recieved the portal message from PCP or the health system.


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.


Recruitment information / eligibility

Status Completed
Enrollment 200
Est. completion date December 31, 2020
Est. primary completion date February 24, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Physician Sent Outreach with Embedded Asynchronous Care in Portal Message
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 Message
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 Message
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 Message
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.

Locations

Country Name City State
United States Oklahoma State University Center for Health Sciences Tulsa Oklahoma

Sponsors (1)

Lead Sponsor Collaborator
Oklahoma State University Center for Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Physician Perceptions of Electronic Outreach 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
Primary Smoking Quit Attempt Smoking Quit Attempt documented in the EMR 30 days after intervention
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