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| ID | Type | Description | Link |
|---|---|---|---|
| R01CA218416 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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Study Investigators are conducting this study to learn how to best implement a new iPad program in clinical practice.
The study team has developed mPATH-CRC (mobile PAtient Technology for Health-Colorectal Cancer), a patient-friendly iPad program used by individuals immediately before a routine primary care visit. mPATH-CheckIn is a module that is used in conjunction with mPATH-CRC that consists of questions asked of all adult patients at check-in. mPATH-CRC is a module specific for patients due for CRC screening.
To fully realize mPATH-CRC's potential to decrease CRC mortality, the program now must be implemented in primary care practices in a way that encourages routine and sustained use. However, while hundreds of mobile health (mHealth) tools have been developed in recent years, the optimal strategies for implementing and maintaining mHealth interventions in clinical practice are unknown. This study will compare the results of a "high touch" strategy to a "low touch" strategy using a Type III hybrid design and incorporating mixed methods to evaluate implementation, maintenance, and effectiveness of mPATH-CRC in a diverse sample of community-based practices.
The study will be conducted in three phases: 1) in a cluster-randomized controlled trial of 22 primary care clinics, the study team will compare the implementation outcomes of a "high touch" evidence-based mHealth implementation strategy with a "low touch" implementation strategy; 2) in a nested pragmatic study, the study team will estimate the effect of mPATH-CRC on completion of CRC screening within 16 weeks of a clinic visit; and 3) by surveying and interviewing clinic staff and providers after implementation is complete, the study team will determine the factors that facilitate or impede the maintenance of mHealth interventions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clinic Patients Eligible for CRC Screening on "high touch" Strategy (Post-Implementation) | Experimental | English or Spanish-speaking patients aged 50-74 who are eligible for CRC screening who are seen in the study clinics randomized to mPATH utilizing the "high touch" implementation strategy in the 12 months after implementation. |
|
| Clinic Patients Eligible for CRC Screening on "low touch" Strategy (Post-Implementation) | Experimental | English or Spanish-speaking patients aged 50-74 who are eligible for CRC screening who are seen in the study clinics randomized to mPATH utilizing the "low touch" implementation strategy in the 12 months after implementation. |
|
| Clinic personnel on "high touch" Strategy (Post-Implementation) | Experimental | Clinic personnel (e.g., administrators, nurses, providers) who are involved with the implementation of mPATH-CRC, in the study clinics randomized to mPATH utilizing the "high touch" implementation strategy in the 12 months after implementation. |
|
| Clinic personnel on "low touch" Strategy (Post-Implementation) | Experimental | Clinic personnel (e.g., administrators, nurses, providers) who are involved with the implementation of mPATH-CRC, in the study clinics randomized to mPATH utilizing the "low touch" implementation strategy in the 12 months after implementation. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mPATH-CRC | Other | mPATH-CRC is a self-administered iPad program that patients eligible for CRC screening use in primary care clinics to help them receive CRC screening. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent of Patients Who Complete the mPATH-CRC Program | mPATH-CRC Implementation: Percent of all eligible patients, ages 50 - 74, who complete the mPATH-CRC program in the 6th month following the implementation date. | Month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| mPATH-CRC Reach (by Socioeconomic Strata) | mPATH-CRC Reach: The proportion of patients, ages 50 - 74, who are given mPATH-CRC or have risk factors identified by mPATH-CheckIn in months 1-6 by varying socioeconomic strata (Describe strata) | up to month 6 |
| mPATH-CRC Adoption |
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This study will include three distinct populations of participants: 1) healthcare providers and staff at primary care practices, 2) patients aged 18 and older seen in the participating study sites, and 3) patients aged 50-74 seen in the participating study sites who are eligible for CRC screening
Patient Inclusion Criteria:
Due for routine CRC screening, defined as:
Patient Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Miller, MD, MS | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27157 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22343624 | Background | Sharp L, Tilson L, Whyte S, O'Ceilleachair A, Walsh C, Usher C, Tappenden P, Chilcott J, Staines A, Barry M, Comber H. Cost-effectiveness of population-based screening for colorectal cancer: a comparison of guaiac-based faecal occult blood testing, faecal immunochemical testing and flexible sigmoidoscopy. Br J Cancer. 2012 Feb 28;106(5):805-16. doi: 10.1038/bjc.2011.580. Epub 2012 Feb 16. | |
| 27305422 | Background | Lin JS, Piper MA, Perdue LA, Rutter CM, Webber EM, O'Connor E, Smith N, Whitlock EP. Screening for Colorectal Cancer: Updated Evidence Report and Systematic Review for the US Preventive Services Task Force. JAMA. 2016 Jun 21;315(23):2576-94. doi: 10.1001/jama.2016.3332. |
| Label | URL |
|---|---|
| Kutner M, Greenburg E, Jin Y, Paulsen C. The Health Literacy of America's Adults: Results from the 2003 National Assessment of Adult Literacy. NCES 2006-483. Natl Cent Educ Stat \[Internet\]. 2006 \[cited 2015 Sep 23\]; | View source |
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We will share de-identified participant data that underlie the results reported in peer-reviewed publications (text, tables, figures, and appendices).
Beginning 6 months and ending 5 years following article publication.
Investigators who provide a methodologically sound proposal to use the participant data in a meta-analysis.
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This is a pragmatic trial, with data being pulled from the electronic health record, so there is no loss to follow-up. A patient enters the dataset once at the time of their clinic visit; they are not actively followed over time but rather a retrospective data pull was conducted at the end of the study for relevant outcomes. The periods described under the description for "high touch" and "low touch" are at the clinic level, not the patient level.
18 clinics were enrolled in the study. These clinics were randomized to the "high touch" or "low touch" implementation strategy. From these 18 clinics, 77145 total participants were enrolled. This includes 67134 adult patients (13092 of whom were eligible for CRC screening) seen in the clinics sometime during the 12 months after implementation, 514 clinic personnel involved in the implementation of mPATH, and 9497 patients in the pre-implementation cohort (8 months prior to implementation).
| ID | Title | Description |
|---|---|---|
| FG000 | "High Touch" Strategy | Populations evaluated include: Patients Eligible for CRC Screening (Pre- and Post-Implementation), All Adult Patients (Post-Implementation), and Clinic Personnel (Post-Implementation) at clinics randomized to the "high touch" strategy. mPATH-CRC: mPATH-CRC is a self-administered iPad program that patients eligible for CRC screening use in primary care clinics to help them receive CRC screening. mPATH-Checkin: The mPATH-CheckIn program includes health questions to assist clinics with patient check-in, thereby incentivizing its use for all patients. "high touch" Implementation strategy: The "high touch" strategy consists of pre-implementation activities, training, and ongoing support. Pre-Implementation Activities
Implementation Kick-Off (Day 1) • On-site training with key clinic personnel Months 1 - 6
Months 7 - 12
|
| FG001 | "Low Touch" Strategy | Populations evaluated include: Patients Eligible for CRC Screening (Pre- and Post-Implementation), All Adult Patients (Post-Implementation), and Clinic Personnel (Post-Implementation) at clinics randomized to the "low touch" strategy. mPATH-CRC: mPATH-CRC is a self-administered iPad program that patients eligible for CRC screening use in primary care clinics to help them receive CRC screening. mPATH-Checkin: The mPATH-CheckIn program includes health questions to assist clinics with patient check-in, thereby incentivizing its use for all patients. "low touch" Implementation Strategy: Clinics randomized to receive the low touch implementation strategy will receive: Pre-Implementation Activities • N/A Implementation Kick-Off (Day 1) • On-site training with key clinic personnel Months 1 - 6
Months 7 - 12
|
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Adult Clinic Patients on "High Touch" Strategy (Post-Implementation) | English or Spanish-speaking patients aged 18 or older who are seen in the study clinics randomized to mPATH utilizing the "high touch" implementation strategy in the 12 months after implementation. mPATH-Checkin: The mPATH-CheckIn program includes health questions to assist clinics with patient check-in, thereby incentivizing its use for all patients. "high touch" Implementation strategy: The "high touch" strategy consists of pre-implementation activities, training, and ongoing support. Pre-Implementation Activities
Implementation Kick-Off (Day 1) • On-site training with key clinic personnel Months 1 - 6
Months 7 - 12
|
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Demographics data are only available for clinic personnel who filled out a survey. "Adult Clinic Patients Eligible for CRC Screening Post-Implementation" is a subset of "All Adult Clinic Patients (Post-Implementation)." The subset is included here because the patients eligible for CRC screening is the analysis population for outcomes related to implementation of mPATH-CRC. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percent of Patients Who Complete the mPATH-CRC Program | mPATH-CRC Implementation: Percent of all eligible patients, ages 50 - 74, who complete the mPATH-CRC program in the 6th month following the implementation date. | The analysis population for this outcome is in the sixth month after implementation, so this is a subset of the overall baseline population that includes patients eligible for CRC screening over the full12 months following implementation. | Posted | Count of Participants | Participants | Month 6 |
|
2 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Clinic Patients Eligible for CRC Screening on "High Touch" Strategy (Post-Implementation) | English or Spanish-speaking patients aged 50-74 who are eligible for CRC screening who are seen in the study clinics randomized to mPATH utilizing the "high touch" implementation strategy in the 12 months after implementation. mPATH-CRC: mPATH-CRC is a self-administered iPad program that patients eligible for CRC screening use in primary care clinics to help them receive CRC screening. mPATH-Checkin: The mPATH-CheckIn program includes health questions to assist clinics with patient check-in, thereby incentivizing its use for all patients. "high touch" Implementation strategy: The "high touch" strategy consists of pre-implementation activities, training, and ongoing support. Pre-Implementation Activities
Implementation Kick-Off (Day 1) • On-site training with key clinic personnel Months 1 - 6
Months 7 - 12
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. David P. Miller, Jr | Wake Forest University School of Medicine | 336-713-5218 | dmiller@wakehealth.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 22, 2023 | Sep 19, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 2, 2022 | Sep 19, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D009369 | Neoplasms |
| D012004 | Rectal Neoplasms |
| D003110 | Colonic Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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|
| All Adult Clinic Patients on "high touch" Strategy (Post-Implementation) | Experimental | English or Spanish-speaking patients aged 18 or older who are seen in the study clinics randomized to mPATH utilizing the "high touch" implementation strategy in the 12 months after implementation. |
|
| All Adult Clinic Patients on "low touch" Strategy (Post-Implementation) | Experimental | English or Spanish-speaking patients aged 18 or older who are seen in the study clinics randomized to mPATH utilizing the "low touch" implementation strategy in the 12 months after implementation. |
|
| Clinic Patients Eligible for CRC Screening on "high touch" Strategy (Pre-Implementation) | Other | English or Spanish-speaking patients aged 50-74 who are eligible for CRC screening who are seen in the study clinics randomized to mPATH utilizing the "high touch" implementation strategy but in 8 months before implementation. |
|
| Clinic Patients Eligible for CRC Screening on "low touch" Strategy (Pre-Implementation) | Other | English or Spanish-speaking patients aged 50-74 who are eligible for CRC screening who are seen in the study clinics randomized to mPATH utilizing the "low touch" implementation strategy but in 8 months before implementation. |
|
| mPATH-Checkin | Other | The mPATH-CheckIn program includes health questions to assist clinics with patient check-in, thereby incentivizing its use for all patients. |
|
| "high touch" Implementation strategy | Other | The "high touch" strategy consists of pre-implementation activities, training, and ongoing support. Pre-Implementation Activities
Implementation Kick-Off (Day 1) • On-site training with key clinic personnel Months 1 - 6
Months 7 - 12
|
|
| "low touch" Implementation Strategy | Other | Clinics randomized to receive the low touch implementation strategy will receive: Pre-Implementation Activities • N/A Implementation Kick-Off (Day 1) • On-site training with key clinic personnel Months 1 - 6
Months 7 - 12
|
|
The mean usage of mPATH-CRC among staff and providers over the first 6 months following implementation; usage is calculated for each staff/provider as the proportion of times mPATH-CRC is completed out of the total times mPATH-CRC should have been launched. |
| up to month 6 |
| mPATH-CheckIn Reach | The proportion of patients aged 18 or older who complete mPATH-CheckIn in months 1-6; this outcome will be calculated overall and within socioeconomic strata | up to month 6 |
| mPATH-CheckIn Adoption | The mean usage of mPATH-CheckIn among staff and providers over the first 6 months following implementation; usage is calculated for front desk staff as the proportion of times mPATH-CheckIn is completed out of the total times mPATH-CheckIn should have been handed out; usage is calculated for nurses/providers as the proportion of times mPATH-CheckIn is completed and data is transmitted to the EHR out of the total times mPATH-CheckIn should have been handed out | up to month 6 |
| mPATH-CRC Implementation Fidelity | The proportion of patients who use mPATH-CRC and request a CRC screening test who have a test ordered or have the order dismissed (i.e., "self-order" feature is used as designed) in months 1-6 | up to month 6 |
| mPATH-CRC Maintenance | The proportion of patients aged 50-74 who are eligible for CRC screening who complete mPATH-CRC or have risk factors identified by mPATH-CheckIn in months 7-12 | months 7-12 |
| mPATH-CheckIn Maintenance | The proportion of patients aged 18 or older who complete mPATH-CheckIn in months 7-12 | months 7-12 |
| CRC Screening Tests Ordered | The outcome is defined as the proportion of patients aged 50-74 who are eligible for CRC screening who have a CRC screening test ordered (colonoscopy, flexible sigmoidoscopy, fecal testing for blood, or fecal DNA testing) within 16 weeks of their index visit to the clinic. This outcome will also be compared between the pre- and post-implementation cohorts. | up to 16 weeks from index visit |
| mPATH-CRC Effectiveness | The proportion of patients aged 50-74 who are eligible for CRC screening who complete CRC screening within 16 weeks of their index visit to the clinic. Effectiveness is determined by comparing the proportion who complete screening in a pre-implementation cohort (months 12 - 4 before implementation) to a post-implementation cohort (months 1 - 8 after implementation). | up to 16 weeks from index visit |
| Facilitators and Barriers to Maintenance (Sustained Use of mPATH-CRC Over Time) | These will be identified through semi-structured interviews. Interviews will explore how mPATH-CRC was incorporated in the clinic's work flow and factors that affected maintenance such as intervention adaptations, organizational characteristics, and the champion's role. Interviews will be conducted with four members of each selected clinic: the clinic champion, one clinician, one front desk team member, and one medical assistant/nursing team member. | Month 12 or month of discontinuation of mPATH use |
| mPATH-CRC Reach (by Month) | The proportion of patients aged 50-74 who are eligible for CRC screening who complete mPATH-CRC or have risk factors identified by mPATH-CheckIn in months 1-5 following implementation | Months 1-5 |
| mPATH-CRC Acceptability | The Acceptability of Intervention Measure (AIM) is a 4-item measure scored on a 5-point scale and summed. The Range of Scores is from 4 to 20. Higher Scores indicate higher acceptability. | month 6 |
| mPATH-CRC Appropriateness | The Intervention Appropriateness Measure (IAM) is a 4-item measure scored on a 5-point scale and summed. The Range of Scores is from 4 to 20. Higher Scores indicate higher appropriateness. | month 6 |
| mPATH-CRC Feasibility | The Feasibility of Intervention Measure (FIM) is a 4-item measure scored on a 5-point scale and summed. The Range of Scores is from 4 to 20. Higher Scores indicate higher feasibility. | month 6 |
| mPATH-CheckIn Acceptability | The Acceptability of Intervention Measure (AIM) is a 4-item measure scored on a 5-point scale and summed. The Range of Scores is from 4 to 20. Higher Scores indicate higher acceptability. | month 6 |
| mPATH-CheckIn Appropriateness | The Intervention Appropriateness Measure (IAM) is a 4-item measure scored on a 5-point scale and summed. The Range of Scores is from 4 to 20. Higher Scores indicate higher appropriateness. | month 6 |
| mPATH-CheckIn Feasibility | The Feasibility of Intervention Measure (FIM) is a 4-item measure scored on a 5-point scale and summed. The Range of Scores is from 4 to 20. Higher Scores indicate higher feasibility. | month 6 |
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| 40323625 | Derived | Miller DP Jr, Snavely AC, Dharod A, Wright E, Randazzo A, Bundy R, Dignan M, Foley KL. High-Touch vs Low-Touch Strategy for Implementing a CRC Screening Digital Health Intervention: A Randomized Clinical Trial. JAMA Intern Med. 2025 Jul 1;185(7):788-795. doi: 10.1001/jamainternmed.2025.0779. |
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| BG001 | All Adult Clinic Patients on "Low Touch" Strategy (Post-Implementation) | English or Spanish-speaking patients aged 18 or older who are seen in the study clinics randomized to mPATH utilizing the "low touch" implementation strategy in the 12 months after implementation. mPATH-Checkin: The mPATH-CheckIn program includes health questions to assist clinics with patient check-in, thereby incentivizing its use for all patients. "low touch" Implementation Strategy: Clinics randomized to receive the low touch implementation strategy will receive: Pre-Implementation Activities • N/A Implementation Kick-Off (Day 1) • On-site training with key clinic personnel Months 1 - 6
Months 7 - 12
|
| BG002 | Clinic Personnel on "High Touch" Strategy (Post-Implementation) | Clinic personnel (e.g., administrators, nurses, providers) who are involved with the implementation of mPATH-CRC, in the study clinics randomized to mPATH utilizing the "high touch" implementation strategy in the 12 months after implementation. mPATH-CRC: mPATH-CRC is a self-administered iPad program that patients eligible for CRC screening use in primary care clinics to help them receive CRC screening. mPATH-Checkin: The mPATH-CheckIn program includes health questions to assist clinics with patient check-in, thereby incentivizing its use for all patients. "high touch" Implementation strategy: The "high touch" strategy consists of pre-implementation activities, training, and ongoing support. Pre-Implementation Activities
Implementation Kick-Off (Day 1) • On-site training with key clinic personnel Months 1 - 6
Months 7 - 12
|
| BG003 | Clinic Personnel on "Low Touch" Strategy (Post-Implementation) | Clinic personnel (e.g., administrators, nurses, providers) who are involved with the implementation of mPATH-CRC, in the study clinics randomized to mPATH utilizing the "low touch" implementation strategy in the 12 months after implementation. mPATH-CRC: mPATH-CRC is a self-administered iPad program that patients eligible for CRC screening use in primary care clinics to help them receive CRC screening. mPATH-Checkin: The mPATH-CheckIn program includes health questions to assist clinics with patient check-in, thereby incentivizing its use for all patients. "low touch" Implementation Strategy: Clinics randomized to receive the low touch implementation strategy will receive: Pre-Implementation Activities • N/A Implementation Kick-Off (Day 1) • On-site training with key clinic personnel Months 1 - 6
Months 7 - 12
|
| BG004 | Clinic Patients Eligible for CRC Screening on "High Touch" Strategy (Pre-Implementation) | English or Spanish-speaking patients aged 50-74 who are eligible for CRC screening who are seen in the study clinics randomized to mPATH utilizing the "high touch" implementation strategy but in 8 months before implementation. "high touch" Implementation strategy: The "high touch" strategy consists of pre-implementation activities, training, and ongoing support. Pre-Implementation Activities
Implementation Kick-Off (Day 1) • On-site training with key clinic personnel Months 1 - 6
Months 7 - 12
|
| BG005 | Clinic Patients Eligible for CRC Screening on "Low Touch" Strategy (Pre-Implementation) | English or Spanish-speaking patients aged 50-74 who are eligible for CRC screening who are seen in the study clinics randomized to mPATH utilizing the "low touch" implementation strategy but in 8 months before implementation. "low touch" Implementation Strategy: Clinics randomized to receive the low touch implementation strategy will receive: Pre-Implementation Activities • N/A Implementation Kick-Off (Day 1) • On-site training with key clinic personnel Months 1 - 6
Months 7 - 12
|
| BG006 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex/Gender, Customized | "Adult Clinic Patients Eligible for CRC Screening Post-Implementation" is a subset of "All Adult Clinic Patients (Post-Implementation)." The subset is included here because the patients eligible for CRC screening is the analysis population for outcomes related to implementation of mPATH-CRC. | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | "Adult Clinic Patients Eligible for CRC Screening Post-Implementation" is a subset of "All Adult Clinic Patients (Post-Implementation)." The subset is included here because the patients eligible for CRC screening is the analysis population for outcomes related to implementation of mPATH-CRC. | Count of Participants | Participants |
|
| Race (NIH/OMB) | "Adult Clinic Patients Eligible for CRC Screening Post-Implementation" is a subset of "All Adult Clinic Patients (Post-Implementation)." The subset is included here because the patients eligible for CRC screening is the analysis population for outcomes related to implementation of mPATH-CRC. | Count of Participants | Participants |
|
| Insurance | "Adult Clinic Patients Eligible for CRC Screening Post-Implementation" is a subset of "All Adult Clinic Patients (Post-Implementation)." The subset is included here because the patients eligible for CRC screening is the analysis population for outcomes related to implementation of mPATH-CRC. | Count of Participants | Participants |
|
| OG001 | Clinic Patients Eligible for CRC Screening on "Low Touch" Strategy (Post-Implementation) | English or Spanish-speaking patients aged 50-74 who are eligible for CRC screening who are seen in the study clinics randomized to mPATH utilizing the "low touch" implementation strategy in the 12 months after implementation. English or Spanish-speaking patients aged 50-74 who are eligible for CRC screening who are seen in the study clinics randomized to mPATH utilizing the "high touch" implementation strategy in the 12 months after implementation. mPATH-CRC: mPATH-CRC is a self-administered iPad program that patients eligible for CRC screening use in primary care clinics to help them receive CRC screening. mPATH-Checkin: The mPATH-CheckIn program includes health questions to assist clinics with patient check-in, thereby incentivizing its use for all patients. "low touch" Implementation Strategy: Clinics randomized to receive the low touch implementation strategy will receive: Pre-Implementation Activities • N/A Implementation Kick-Off (Day 1) • On-site training with key clinic personnel Months 1 - 6
Months 7 - 12
|
|
|
| Secondary | mPATH-CRC Reach (by Socioeconomic Strata) | mPATH-CRC Reach: The proportion of patients, ages 50 - 74, who are given mPATH-CRC or have risk factors identified by mPATH-CheckIn in months 1-6 by varying socioeconomic strata (Describe strata) | Not Posted | up to month 6 | Participants |
| Secondary | mPATH-CRC Adoption | The mean usage of mPATH-CRC among staff and providers over the first 6 months following implementation; usage is calculated for each staff/provider as the proportion of times mPATH-CRC is completed out of the total times mPATH-CRC should have been launched. | Not Posted | up to month 6 | Participants |
| Secondary | mPATH-CheckIn Reach | The proportion of patients aged 18 or older who complete mPATH-CheckIn in months 1-6; this outcome will be calculated overall and within socioeconomic strata | Not Posted | up to month 6 | Participants |
| Secondary | mPATH-CheckIn Adoption | The mean usage of mPATH-CheckIn among staff and providers over the first 6 months following implementation; usage is calculated for front desk staff as the proportion of times mPATH-CheckIn is completed out of the total times mPATH-CheckIn should have been handed out; usage is calculated for nurses/providers as the proportion of times mPATH-CheckIn is completed and data is transmitted to the EHR out of the total times mPATH-CheckIn should have been handed out | Not Posted | up to month 6 | Participants |
| Secondary | mPATH-CRC Implementation Fidelity | The proportion of patients who use mPATH-CRC and request a CRC screening test who have a test ordered or have the order dismissed (i.e., "self-order" feature is used as designed) in months 1-6 | Not Posted | up to month 6 | Participants |
| Secondary | mPATH-CRC Maintenance | The proportion of patients aged 50-74 who are eligible for CRC screening who complete mPATH-CRC or have risk factors identified by mPATH-CheckIn in months 7-12 | Not Posted | months 7-12 | Participants |
| Secondary | mPATH-CheckIn Maintenance | The proportion of patients aged 18 or older who complete mPATH-CheckIn in months 7-12 | Not Posted | months 7-12 | Participants |
| Secondary | CRC Screening Tests Ordered | The outcome is defined as the proportion of patients aged 50-74 who are eligible for CRC screening who have a CRC screening test ordered (colonoscopy, flexible sigmoidoscopy, fecal testing for blood, or fecal DNA testing) within 16 weeks of their index visit to the clinic. This outcome will also be compared between the pre- and post-implementation cohorts. | Not Posted | up to 16 weeks from index visit | Participants |
| Secondary | mPATH-CRC Effectiveness | The proportion of patients aged 50-74 who are eligible for CRC screening who complete CRC screening within 16 weeks of their index visit to the clinic. Effectiveness is determined by comparing the proportion who complete screening in a pre-implementation cohort (months 12 - 4 before implementation) to a post-implementation cohort (months 1 - 8 after implementation). | Not Posted | up to 16 weeks from index visit | Participants |
| Secondary | Facilitators and Barriers to Maintenance (Sustained Use of mPATH-CRC Over Time) | These will be identified through semi-structured interviews. Interviews will explore how mPATH-CRC was incorporated in the clinic's work flow and factors that affected maintenance such as intervention adaptations, organizational characteristics, and the champion's role. Interviews will be conducted with four members of each selected clinic: the clinic champion, one clinician, one front desk team member, and one medical assistant/nursing team member. | Not Posted | Month 12 or month of discontinuation of mPATH use | Participants |
| Secondary | mPATH-CRC Reach (by Month) | The proportion of patients aged 50-74 who are eligible for CRC screening who complete mPATH-CRC or have risk factors identified by mPATH-CheckIn in months 1-5 following implementation | Not Posted | Months 1-5 | Participants |
| Secondary | mPATH-CRC Acceptability | The Acceptability of Intervention Measure (AIM) is a 4-item measure scored on a 5-point scale and summed. The Range of Scores is from 4 to 20. Higher Scores indicate higher acceptability. | Not Posted | month 6 | Participants |
| Secondary | mPATH-CRC Appropriateness | The Intervention Appropriateness Measure (IAM) is a 4-item measure scored on a 5-point scale and summed. The Range of Scores is from 4 to 20. Higher Scores indicate higher appropriateness. | Not Posted | month 6 | Participants |
| Secondary | mPATH-CRC Feasibility | The Feasibility of Intervention Measure (FIM) is a 4-item measure scored on a 5-point scale and summed. The Range of Scores is from 4 to 20. Higher Scores indicate higher feasibility. | Not Posted | month 6 | Participants |
| Secondary | mPATH-CheckIn Acceptability | The Acceptability of Intervention Measure (AIM) is a 4-item measure scored on a 5-point scale and summed. The Range of Scores is from 4 to 20. Higher Scores indicate higher acceptability. | Not Posted | month 6 | Participants |
| Secondary | mPATH-CheckIn Appropriateness | The Intervention Appropriateness Measure (IAM) is a 4-item measure scored on a 5-point scale and summed. The Range of Scores is from 4 to 20. Higher Scores indicate higher appropriateness. | Not Posted | month 6 | Participants |
| Secondary | mPATH-CheckIn Feasibility | The Feasibility of Intervention Measure (FIM) is a 4-item measure scored on a 5-point scale and summed. The Range of Scores is from 4 to 20. Higher Scores indicate higher feasibility. | Not Posted | month 6 | Participants |
| 0 |
| 7,933 |
| 0 |
| 7,933 |
| 0 |
| 7,933 |
| EG001 | Clinic Patients Eligible for CRC Screening on "Low Touch" Strategy (Post-Implementation) | English or Spanish-speaking patients aged 50-74 who are eligible for CRC screening who are seen in the study clinics randomized to mPATH utilizing the "low touch" implementation strategy in the 12 months after implementation. mPATH-CRC: mPATH-CRC is a self-administered iPad program that patients eligible for CRC screening use in primary care clinics to help them receive CRC screening. mPATH-Checkin: The mPATH-CheckIn program includes health questions to assist clinics with patient check-in, thereby incentivizing its use for all patients. "low touch" Implementation Strategy: Clinics randomized to receive the low touch implementation strategy will receive: Pre-Implementation Activities • N/A Implementation Kick-Off (Day 1) • On-site training with key clinic personnel Months 1 - 6
Months 7 - 12
| 0 | 5,159 | 0 | 5,159 | 0 | 5,159 |
| EG002 | All Adult Clinic Patients on "High Touch" Strategy (Post-Implementation) | English or Spanish-speaking patients aged 18 or older who are seen in the study clinics randomized to mPATH utilizing the "high touch" implementation strategy in the 12 months after implementation. mPATH-Checkin: The mPATH-CheckIn program includes health questions to assist clinics with patient check-in, thereby incentivizing its use for all patients. "high touch" Implementation strategy: The "high touch" strategy consists of pre-implementation activities, training, and ongoing support. Pre-Implementation Activities
Implementation Kick-Off (Day 1) • On-site training with key clinic personnel Months 1 - 6
Months 7 - 12
| 0 | 43,775 | 0 | 43,775 | 0 | 43,775 |
| EG003 | All Adult Clinic Patients on "Low Touch" Strategy (Post-Implementation) | English or Spanish-speaking patients aged 18 or older who are seen in the study clinics randomized to mPATH utilizing the "low touch" implementation strategy in the 12 months after implementation. mPATH-Checkin: The mPATH-CheckIn program includes health questions to assist clinics with patient check-in, thereby incentivizing its use for all patients. "low touch" Implementation Strategy: Clinics randomized to receive the low touch implementation strategy will receive: Pre-Implementation Activities • N/A Implementation Kick-Off (Day 1) • On-site training with key clinic personnel Months 1 - 6
Months 7 - 12
| 0 | 23,359 | 0 | 23,359 | 0 | 23,359 |
| EG004 | Clinic Personnel on "High Touch" Strategy (Post-Implementation) | Clinic personnel (e.g., administrators, nurses, providers) who are involved with the implementation of mPATH-CRC, in the study clinics randomized to mPATH utilizing the "high touch" implementation strategy in the 12 months after implementation. mPATH-CRC: mPATH-CRC is a self-administered iPad program that patients eligible for CRC screening use in primary care clinics to help them receive CRC screening. mPATH-Checkin: The mPATH-CheckIn program includes health questions to assist clinics with patient check-in, thereby incentivizing its use for all patients. "high touch" Implementation strategy: The "high touch" strategy consists of pre-implementation activities, training, and ongoing support. Pre-Implementation Activities
Implementation Kick-Off (Day 1) • On-site training with key clinic personnel Months 1 - 6
Months 7 - 12
| 0 | 282 | 0 | 282 | 0 | 282 |
| EG005 | Clinic Personnel on "Low Touch" Strategy (Post-Implementation) | Clinic personnel (e.g., administrators, nurses, providers) who are involved with the implementation of mPATH-CRC, in the study clinics randomized to mPATH utilizing the "low touch" implementation strategy in the 12 months after implementation. mPATH-CRC: mPATH-CRC is a self-administered iPad program that patients eligible for CRC screening use in primary care clinics to help them receive CRC screening. mPATH-Checkin: The mPATH-CheckIn program includes health questions to assist clinics with patient check-in, thereby incentivizing its use for all patients. "low touch" Implementation Strategy: Clinics randomized to receive the low touch implementation strategy will receive: Pre-Implementation Activities • N/A Implementation Kick-Off (Day 1) • On-site training with key clinic personnel Months 1 - 6
Months 7 - 12
| 0 | 232 | 0 | 232 | 0 | 232 |
| EG006 | Clinic Patients Eligible for CRC Screening on "High Touch" Strategy (Pre-Implementation) | English or Spanish-speaking patients aged 50-74 who are eligible for CRC screening who are seen in the study clinics randomized to mPATH utilizing the "high touch" implementation strategy but in 8 months before implementation. "high touch" Implementation strategy: The "high touch" strategy consists of pre-implementation activities, training, and ongoing support. Pre-Implementation Activities
Implementation Kick-Off (Day 1) • On-site training with key clinic personnel Months 1 - 6
Months 7 - 12
| 0 | 5,526 | 0 | 5,526 | 0 | 5,526 |
| EG007 | Clinic Patients Eligible for CRC Screening on "Low Touch" Strategy (Pre-Implementation) | English or Spanish-speaking patients aged 50-74 who are eligible for CRC screening who are seen in the study clinics randomized to mPATH utilizing the "low touch" implementation strategy but in 8 months before implementation. "low touch" Implementation Strategy: Clinics randomized to receive the low touch implementation strategy will receive: Pre-Implementation Activities • N/A Implementation Kick-Off (Day 1) • On-site training with key clinic personnel Months 1 - 6
Months 7 - 12
| 0 | 3,971 | 0 | 3,971 | 0 | 3,971 |
Not provided
Not provided
Not provided
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
|
| Female |
|
| Unknown |
|
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
| Medicare |
|
| Medicaid |
|
| Other |
|
| Uninsured |
|
| Unknown |
|
|