NCT05172219

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 13, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 24, 2020

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

November 30, 2021

Completed
29 days until next milestone

First Posted

Study publicly available on registry

December 29, 2021

Completed
Last Updated

December 29, 2021

Status Verified

December 1, 2021

Enrollment Period

1 month

First QC Date

November 30, 2021

Last Update Submit

December 28, 2021

Conditions

Keywords

Smoking Quit AttemptsQuality ImprovementAsynchronous CareElectronic Messaging

Outcome Measures

Primary Outcomes (1)

  • Smoking Quit Attempt

    Smoking Quit Attempt documented in the EMR

    30 days after intervention

Other Outcomes (1)

  • Physician Perceptions of Electronic Outreach Intervention

    6 months after intervention

Study Arms (4)

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.

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.

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.

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.

Behavioral: System Sent Outreach with Embedded Asynchronous Care in Portal Message

Interventions

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.

Also known as: PSL
Message Type PSL: Physician sender, Survey Link

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.

Also known as: PNSL
Message Type PNSL: Physician sender, No Survey Link

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.

Also known as: SSL
Message Type SSL: System sender, Survey Link

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.

Also known as: SNSL
Message Type SNSL: System sender, No Survey Link

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oklahoma State University Center for Health Sciences

Tulsa, Oklahoma, 74107, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Tobacco Smoking

Condition Hierarchy (Ancestors)

SmokingBehaviorTobacco Use

Study Officials

  • Marjorie A Erdmann, MS

    Oklahoma State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Participants: The patients were not informed of other portal messages. The portal message they received (if it had a link to asynchronous care or not and if it was sent by physician or system) was determined by random assignment. Care Providers: After reviewing patients for exclusion criteria, the physicians were not informed which intervention group patients were assigned. They knew who was selected for the study and then those patients were randomly assigned to intervention groups by computerized randomization system. Investigators: The data was extracted from the EHR and de-identified prior to sharing it with the investigators. Therefore, the investigators were blind to patients and patient assignment. Outcomes Assessor: Outcomes were assessed only from de-identified data.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: The model was a 2 (link to survey) Ă— 2 (message source) experimental design; therefore, we had two factors that created four treatment conditions.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 30, 2021

First Posted

December 29, 2021

Study Start

January 13, 2020

Primary Completion

February 24, 2020

Study Completion

December 31, 2020

Last Updated

December 29, 2021

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

Locations