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

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.

Study Overview

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

Interventional

Enrollment (Actual)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Oklahoma
      • Tulsa, Oklahoma, United States, 74107
        • Oklahoma State University Center for Health Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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:
  • PNSL
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:
  • PSL
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:
  • SNSL
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:
  • SSL

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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Marjorie A Erdmann, MS, Oklahoma State University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 13, 2020

Primary Completion (Actual)

February 24, 2020

Study Completion (Actual)

December 31, 2020

Study Registration Dates

First Submitted

November 30, 2021

First Submitted That Met QC Criteria

December 28, 2021

First Posted (Actual)

December 29, 2021

Study Record Updates

Last Update Posted (Actual)

December 29, 2021

Last Update Submitted That Met QC Criteria

December 28, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

Clinical Trials on Smoking, Tobacco

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