Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| P50CA271338 | U.S. NIH Grant/Contract | View source | |
| 850376 | Other Identifier | Penn IRB |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Cancer Institute (NCI) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
The goal of this pragmatic trial is to learn if telehealth strategies can increase shared decision-making (SDM) for lung cancer screening (LCS). It will also learn about the equity of these strategies by conducting non-inferiority analysis by race and sex. The main questions it aims to answer are:
The study uses a Sequential Multiple Assignment Randomized Trial (SMART) design and includes two stages of interventions. The first stage of intervention includes direct patient outreach with an invitation to schedule either a 1) telehealth SDM visit or 2) telehealth or in-person SDM visit. Participants that do not respond to the first stage interventions receive a text message reminder encouraging SDM visit completion with or without digital care coordination.
Annual lung cancer screening using low-dose computed tomography (LDCT) is associated with decreased lung cancer mortality but also with harms. As such, it is recommended, and required for reimbursement, that patients complete an shared decision-making visit (SDM) prior to screening to discuss potential risks and benefits in the context of patient values. Despite guidelines recommending screening and national insurance coverage of LDCT, uptake of SDM visits and subsequent LDCT is remarkably low. We aim to address these gaps by comparing the effectiveness of synchronous and asynchronous telehealth strategies on SDM visits and subsequent LDCT in a pragmatic trial using a Sequential Multiple Assignment Randomized Trial (SMART) design. The specific first stage strategies to be tested are: a) Active Choice Outreach (invitation to schedule a telehealth or in-person SDM visit) vs b) Telehealth Only Outreach (invitation to schedule a telehealth SDM visit). The specific second stage strategies (delivered only if participants do not respond to first stage interventions) are a) text message reminders encouraging SDM visit completion (low-touch) alone or b) in combination with phone-based digital care coordination (high-touch). We will also assess non-inferiority of strategies by race and sex to assess equity of effectiveness.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Choice (Stage 1) + Low Touch (Stage 2) | Experimental | Participants in this arm will be offered the option via outreach letter to complete an SDM visit via telehealth or in-person (Stage 1) and if individuals do not schedule an SDM visit within 30 days (non-responders), they will receive asynchronous text messages alone (Stage 2) |
|
| Active Choice (Stage 1) + High Touch (Stage 2) | Experimental | Participants in this arm will be offered the option via outreach letter to complete an SDM visit via telehealth or in-person (Stage 1) and if individuals do not schedule an SDM visit within 30 days (non-responders), they will receive asynchronous text messages in combination with synchronous digital care coordination (Stage 2). |
|
| Telehealth Only (Stage 1) + Low Touch (Stage 2) | Experimental | Participants in this arm will be offered the option via outreach letter to complete an SDM visit via telehealth only (Stage 1) and if individuals do not schedule an SDM visit within 30 days (non-responders), they will receive asynchronous text messages alone (Stage 2). |
|
| Telehealth Only (Stage 1) + High Touch (Stage 2) | Experimental | Participants in this arm will be offered the option via outreach letter to complete an SDM visit via telehealth only (Stage 1) and if individuals do not schedule an SDM visit within 30 days (non-responders), they will receive asynchronous text messages in combination with synchronous digital care coordination (Stage 2). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active Choice | Behavioral | The participant will be send a letter inviting them to complete a SDM visit either in-person or via telehealth. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Shared decision making (SDM) for lung cancer screening (LCS) | Completion of an SDM visit (in person or telehealth) defined as any completed encounter that has documented SDM for LCS as indicated by 1) procedure code (G0296 or equivalent), or documentation of SDM conversation related to LCS in associated progress notes. | 90 days after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Low-dose computed tomography (LDCT) | Completion of LDCT within 6 months of randomization date among individuals who complete SDM and are determined to be eligible for LCS. | 6 months after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Fidelity to Shared Decision-Making | Completion of key components of SDM for LCS including:
| Up to 90 days after randomization |
| Fidelity to Digital Care Coordination |
Inclusion criteria:
Participants will be eligible if:
Exclusion criteria:
Participants who do not meet inclusion criteria will not be eligible.
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Katharine Rendle, PhD | Contact | 215-349-5442 | katharine.rendle@pennmedicine.upenn.edu | |
| Hannah Toneff, MSW, MA | Contact | 267-882-3186 | Hannah.Toneff@pennmedicine.upenn.edu |
| Name | Affiliation | Role |
|---|---|---|
| Katharine Rendle, PhD | Abramson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pennsylvania | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study uses a sequential randomization design in which all eligible participants will be randomized into one of two interventions at Stage 1 and then participants that do not respond to Stage 1 interventions will be randomized to receive Stage 2 interventions
Not provided
Not provided
Not provided
|
| Telehealth Only | Behavioral | The participant will be send a letter inviting them to complete a SDM visit via telehealth only. |
|
| Low Touch Strategy | Behavioral | Patient will be sent asynchronous text messaging reminders encouraging SDM for LCS using framed messaging. |
|
| High Touch Strategy | Behavioral | Patient will be sent asynchronous text messaging reminders encouraging SDM for LCS using framed messaging in combination with synchronous telephone-based digital care coordination. |
|
Completion of key components of digital care coordination including assessing digital needs and readiness, providing technological support, answering questions about security or safety, and helping to coordinate telehealth appointments. |
| Up to 90 days after randomization |
| Lung cancer diagnoses | Number of people diagnosed with lung cancer after randomization. | 12 months after randomization |
| Reach: Text Message Delivery | The number of participants who are successfully delivered text messages divided by those who are sent text messages in Stage 2. | Up to 90 days after randomization |
| Reach: Digital Care Coordination | The number of participants who complete a digital care coordination visit divided by those contacted by the Digital Care Coordinator in Stage 2. | Up to 90 days after randomization |
| Reach: Scheduling | The number of participants who schedule an SDM visit divided by those who are sent initial outreach. | Up to 90 days after randomization |
| Timeliness | The number of days between randomization and SDM completion among subjects who complete SDM for LCS. | Up to 12 months after randomization |