Increasing Digital Equity and Access Among Rural Patients (IDEA) Study

NCT05209451 | Completed

• 1 other identifier: 21-011617
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research is to learn more about how access to digital resources impacts healthcare and smoking cessation in rural areas of Minnesota, Iowa, and Wisconsin. Aim 1: Conduct a pragmatic randomized clinical trial and use mixed methods to assess the impact of providing access to technology and/or coaching support on participation in and response to a digital, evidence-based behavioral health program for smoking cessation. Aim 2: Assess the feasibility and patient experience of providing electronic remuneration and a loaner device with data plan coverage to access the Internet for remote clinical trials participation.

Conditions

Smoking Cessation

Keywords

Rural; Smoking; Smoking cessation; Treatment; Intervention; Digital; Literacy; Equity; Inclusion; Community Engagement

Outcome Measures

Primary Outcomes (1)

• Trial engagement

  Composite measure of assessment completion and use of online cessation program

  12 weeks

Secondary Outcomes (3)

• Smoking abstinence

  4 and 12 weeks

• Use of evidence-based smoking cessation treatment

  4 and 12 weeks

• Patient experience

  12 weeks

Study Arms (3)

Control Condition - No additional study intervention

ACTIVE COMPARATOR

Subjects will receive a 12-week, digital, evidence-based behavioral health program for smoking cessation delivered through the patient portal and a written guide on existing digital access resources along with any other necessary material.

Behavioral: Digital, evidence-based behavioral health program for smoking cessation

Loaner Digital Device

EXPERIMENTAL

Subjects will receive a 12-week, digital, evidence-based behavioral health program for smoking cessation delivered through the patient portal and a written guide on existing digital access resources along with any other necessary material. Participants in this group will also receive a loaned Bluetooth enabled iPad with data plan coverage for the study duration.

Behavioral: Digital, evidence-based behavioral health program for smoking cessation; Other: Bluetooth enabled iPad

Loaner Digital Device + Coaching Support

EXPERIMENTAL

Subjects will receive a 12-week, digital, evidence-based behavioral health program for smoking cessation delivered through the patient portal and a written guide on existing digital access resources along with any other necessary material. Participants in this group will also receive a loaned Bluetooth enabled iPad with data plan coverage for the study duration plus up to six coaching call, 15-20 minutes in duration.

Behavioral: Digital, evidence-based behavioral health program for smoking cessation; Behavioral: Coaching Support

Interventions

Digital, evidence-based behavioral health program for smoking cessation BEHAVIORAL

Remotely delivered, 12-week smoking cessation program delivered through the patient portal. The program will deliver a smoking cessation intervention that links study participants to tailored, interactive and effective evidence-based smoking cessation resources.

Control Condition - No additional study intervention; Loaner Digital Device; Loaner Digital Device + Coaching Support

Bluetooth enabled iPad OTHER

Bluetooth enabled iPad with data plan coverage that provides a personal Wi-Fi (Internet) hot spot for all home devices and allows for up to 64 GB of cellular data.

Loaner Digital Device

Coaching Support BEHAVIORAL

Six coaching calls, 15-20 minutes each in duration. The research coach will use motivational interviewing and goal setting to enhance the participant's technology access and use and digital literacy.

Loaner Digital Device + Coaching Support

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A Mayo Clinic Midwest patient (Mayo Clinic Rochester or Mayo Clinic Health System \[MCHS\]) with a Mayo Clinic number.
• Aged 18 years or older.
• Can read and speak in the English language. Based on 2019 data, 97% of our Rochester and MCHS patients speak English. The study will provide all participants with a smoking cessation program delivered through the Mayo Clinic patient portal. Currently, Mayo Clinic's portal services are not offered in languages other than English.
• Has a Minnesota, Iowa, or Wisconsin address currently or at date of most recent visit to Mayo Clinic.
• Rural resident based on RUCA codes derived from ZIP code of current or last known address.
• Has access to a telephone of any type (e.g., landline, smartphone). Access to a telephone is needed to complete the coaching support intervention and to follow-up with participants if there are issues with accessing the patient portal for the smoking cessation intervention.
• Current smoker defined as one or more cigarettes (even a puff) smoked in the past 30 days (original criteria). This definition allows for enrollment of non-daily and/or light smoking enhancing the generalizability. In addition to cigarettes, cigarillos and cigars are combustible tobacco products and thus relevant as a focus for our study. Thus, the protocol was modified with IRB approval to change this criterion to include other combustible tobacco use. The final criterion was "Current smoker defined as one or more cigarettes, cigarillos, or cigars (even a puff) smoked in the past 30 days." To enhance the generalizability of our findings, we will enroll participants using other tobacco/nicotine products if cigarette, cigarillo or cigar smoking is the primary product used
• For past 3 months not enrolled in a program or use of cessation pharmacotherapy (original criterion). The protocol was modified with IRB approval to allow for ad hoc use to enhance generalizability. The final criterion was "For past 3 months not enrolled in a program or use of cessation pharmacotherapy other than ad hoc use, for example used nicotine gum or lozenge once or twice."
• Willing to make a quit smoking attempt.
• Has a patient portal account, or is willing to create a patient portal account.
• Has an email address to provide to study staff, or is willing to create an email address.
• Has digital access barriers defined by one or more of the following:
• based on participant ZIP code from current or last known address geocoded census block group indicates area of poor BB internet coverage; (b) no existing Mayo Clinic patient portal account or (c) has a Mayo Clinic patient portal account but has not used it in the past 5 years; (d) self-reports having no access to broadband (high speed) internet connection for personal use; and/or (e) self-reports low digital literacy defined with the screening question "How comfortable are you using technology to manage your health care remotely? For example, using patient online services (i.e., patient portal) to schedule appointments, check for test results, or send a message to your provider?" (included: not at all or a little comfortable).

You may not qualify if:

• Has participated in a behavioral smoking cessation program in the past 3 months

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic Rochester

Rochester, Minnesota, 55905, United States

Location

Related Publications (3)

• Kelpin S, Brockman TA, Decker PA, Young A, Boehmer K, Nguyen A, Kamath C, St Sauver J, Sinicrope PS, Sharma P, McCoy R, Allen S, Huang M, Pritchett J, Esterov D, Lampman M, Petersen C, Cheville A, Patten CA. Increasing digital equity to promote online smoking cessation program engagement among rural adults: a randomized controlled pilot trial. Commun Med (Lond). 2024 Oct 8;4(1):194. doi: 10.1038/s43856-024-00624-6.

  PMID: 39375517 DERIVED

• Patten CA, Koller KR, King DK, Prochaska JJ, Sinicrope PS, McDonell MG, Decker PA, Lee FR, Fosi JK, Young AM, Sabaque CV, Brown AR, Borah BJ, Thomas TK. Aniqsaaq (To Breathe): Study protocol to develop and evaluate an Alaska Native family-based financial incentive intervention for smoking cessation. Contemp Clin Trials Commun. 2023 Apr 3;33:101129. doi: 10.1016/j.conctc.2023.101129. eCollection 2023 Jun.

  PMID: 37091507 DERIVED

• Patten C, Brockman T, Kelpin S, Sinicrope P, Boehmer K, St Sauver J, Lampman M, Sharma P, Reinicke N, Huang M, McCoy R, Allen S, Pritchett J, Esterov D, Kamath C, Decker P, Petersen C, Cheville A. Interventions for Increasing Digital Equity and Access (IDEA) among rural patients who smoke: Study protocol for a pragmatic randomized pilot trial. Contemp Clin Trials. 2022 Aug;119:106838. doi: 10.1016/j.cct.2022.106838. Epub 2022 Jun 25.

  PMID: 35760340 DERIVED

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Smoking Cessation; Smoking; Literacy

Condition Hierarchy (Ancestors)

Health Behavior; Behavior; Communication

Study Officials

• Christi Patten, PhD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 10, 2022
• First Posted: January 26, 2022
• Study Start: February 11, 2022
• Primary Completion: February 17, 2023
• Study Completion: February 17, 2023
• Last Updated: September 20, 2024

Record last verified: 2024-09

Locations

US (1)