Cancer, Colon Cancer, Colorectal Cancer, Rectum Cancer
Conditions
Keywords
Mortality, Cancer Screening, Cancer Intervention, Mobile Health, Implementation Science
Brief summary
Study Investigators are conducting this study to learn how to best implement a new iPad program in clinical practice.
Detailed description
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.
Interventions
OTHERmPATH-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.
OTHERmPATH-Checkin
The mPATH-CheckIn program includes health questions to assist clinics with patient check-in, thereby incentivizing its use for all patients.
OTHERhigh touch Implementation strategy
The high touch strategy consists of pre-implementation activities, training, and ongoing support. Pre-Implementation Activities * Clinic champion identified. * Study team meeting with clinic champion * Implementation adaptations as needed for clinic flow Implementation Kick-Off (Day 1) • On-site training with key clinic personnel Months 1 - 6 * Phone/email technical support, as needed. * Access to web-based QA dashboard * Monthly program usage report sent to clinic champions * Scheduled phone-calls with clinic champion to review QA data and explore potential barriers. * Implementation adaptations as needed for clinic flow * Goal-triggered follow-up on-site trainings * Additional on-site trainings as requested. Months 7 - 12 * Phone/email technical support, as needed * Access to web-based QA dashboard
OTHERlow 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 * Phone/email technical support, as needed. * Access to web-based QA dashboard Months 7 - 12 * Phone/email technical support, as needed * Access to web-based QA dashboard
Sponsors
National Cancer Institute (NCI)
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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: * No colonoscopy within the prior 10 years * No flexible sigmoidoscopy within the prior 5 years * No CT colonography within the prior 5 years * No fecal DNA testing within the prior 3 years * No fecal blood testing (guaiac-based test with home kit or fecal immunochemical test) within the prior 12 months Patient
Exclusion criteria
* Personal history of CRC * First degree relative with CRC * Personal history of colorectal polyps
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent of Patients Who Complete the mPATH-CRC Program | Month 6 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| mPATH-CRC Adoption | up to month 6 | 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. |
| mPATH-CheckIn Reach | up to month 6 | 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 |
| mPATH-CheckIn Adoption | up to month 6 | 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 |
| mPATH-CRC Implementation Fidelity | up to month 6 | 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 |
| mPATH-CRC Maintenance | months 7-12 | 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 |
| mPATH-CheckIn Maintenance | months 7-12 | The proportion of patients aged 18 or older who complete mPATH-CheckIn in months 7-12 |
| CRC Screening Tests Ordered | up to 16 weeks from index visit | 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. |
| mPATH-CRC Effectiveness | up to 16 weeks from index visit | 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). |
| mPATH-CRC Reach (by Socioeconomic Strata) | up to month 6 | 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) |
| mPATH-CRC Reach (by Month) | Months 1-5 | 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 |
| mPATH-CRC Acceptability | month 6 | 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. |
| mPATH-CRC Appropriateness | month 6 | 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. |
| mPATH-CRC Feasibility | month 6 | 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. |
| mPATH-CheckIn Acceptability | month 6 | 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. |
| mPATH-CheckIn Appropriateness | month 6 | 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. |
| mPATH-CheckIn Feasibility | month 6 | 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. |
| Facilitators and Barriers to Maintenance (Sustained Use of mPATH-CRC Over Time) | Month 12 or month of discontinuation of mPATH use | 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. |
Countries
United States
Participant flow
Recruitment details
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).
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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
* Clinic champion identified.
* Study team meeting with clinic champion
* Implementation adaptations as needed for clinic flow
Implementation Kick-Off (Day 1)
• On-site training with key clinic personnel
Months 1 - 6
* Phone/email technical support, as needed.
* Access to web-based QA dashboard
* Monthly program usage report sent to clinic champions
* Scheduled phone-calls with clinic champion to review QA data and explore potential barriers.
* Implementation adaptations as needed for clinic flow
* Goal-triggered follow-up on-site trainings
* Additional on-site trainings as requested.
Months 7 - 12
* Phone/email technical support, as needed
* Access to web-based QA dashboard | 43,775 |
| 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
* Phone/email technical support, as needed.
* Access to web-based QA dashboard
Months 7 - 12
* Phone/email technical support, as needed
* Access to web-based QA dashboard | 23,359 |
| 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
* Clinic champion identified.
* Study team meeting with clinic champion
* Implementation adaptations as needed for clinic flow
Implementation Kick-Off (Day 1)
• On-site training with key clinic personnel
Months 1 - 6
* Phone/email technical support, as needed.
* Access to web-based QA dashboard
* Monthly program usage report sent to clinic champions
* Scheduled phone-calls with clinic champion to review QA data and explore potential barriers.
* Implementation adaptations as needed for clinic flow
* Goal-triggered follow-up on-site trainings
* Additional on-site trainings as requested.
Months 7 - 12
* Phone/email technical support, as needed
* Access to web-based QA dashboard | 282 |
| 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
* Phone/email technical support, as needed.
* Access to web-based QA dashboard
Months 7 - 12
* Phone/email technical support, as needed
* Access to web-based QA dashboard | 232 |
| 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
* Clinic champion identified.
* Study team meeting with clinic champion
* Implementation adaptations as needed for clinic flow
Implementation Kick-Off (Day 1)
• On-site training with key clinic personnel
Months 1 - 6
* Phone/email technical support, as needed.
* Access to web-based QA dashboard
* Monthly program usage report sent to clinic champions
* Scheduled phone-calls with clinic champion to review QA data and explore potential barriers.
* Implementation adaptations as needed for clinic flow
* Goal-triggered follow-up on-site trainings
* Additional on-site trainings as requested.
Months 7 - 12
* Phone/email technical support, as needed
* Access to web-based QA dashboard | 5,526 |
| 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
* Phone/email technical support, as needed.
* Access to web-based QA dashboard
Months 7 - 12
* Phone/email technical support, as needed
* Access to web-based QA dashboard | 3,971 |
| Total | 77,145 |
Baseline characteristics
| Characteristic | All Adult Clinic Patients on High Touch Strategy (Post-Implementation) | All Adult Clinic Patients on Low Touch Strategy (Post-Implementation) | Total | Clinic Personnel on Low Touch Strategy (Post-Implementation) | Clinic Patients Eligible for CRC Screening on High Touch Strategy (Pre-Implementation) | Clinic Patients Eligible for CRC Screening on Low Touch Strategy (Pre-Implementation) | Clinic Personnel on High Touch Strategy (Post-Implementation) |
|---|---|---|---|---|---|---|---|
| Age, Continuous Adult Clinic Patients Eligible for CRC Screening Post-Implementation | 59.9 years STANDARD_DEVIATION 7.2 | 59.6 years STANDARD_DEVIATION 6.9 | 59.8 years STANDARD_DEVIATION 7.1 | — | — | — | — |
| Age, Continuous All Participants | 55.0 years STANDARD_DEVIATION 17.7 | 52.3 years STANDARD_DEVIATION 17.8 | 54.7 years STANDARD_DEVIATION 16.9 | 37.6 years STANDARD_DEVIATION 8.4 | 59.5 years STANDARD_DEVIATION 7.1 | 59.4 years STANDARD_DEVIATION 6.9 | 37.0 years STANDARD_DEVIATION 8.8 |
| Ethnicity (NIH/OMB) Adult Clinic Patients Eligible for CRC Screening Post-Implementation Hispanic or Latino | 444 Participants | 195 Participants | 639 Participants | — | — | — | — |
| Ethnicity (NIH/OMB) Adult Clinic Patients Eligible for CRC Screening Post-Implementation Not Hispanic or Latino | 7419 Participants | 4937 Participants | 12356 Participants | — | — | — | — |
| Ethnicity (NIH/OMB) Adult Clinic Patients Eligible for CRC Screening Post-Implementation Unknown or Not Reported | 70 Participants | 27 Participants | 97 Participants | — | — | — | — |
| Ethnicity (NIH/OMB) All Participants Hispanic or Latino | 2412 Participants | 955 Participants | 3863 Participants | 7 Participants | 361 Participants | 114 Participants | 14 Participants |
| Ethnicity (NIH/OMB) All Participants Not Hispanic or Latino | 41035 Participants | 22286 Participants | 72542 Participants | 107 Participants | 5112 Participants | 3840 Participants | 162 Participants |
| Ethnicity (NIH/OMB) All Participants Unknown or Not Reported | 328 Participants | 118 Participants | 740 Participants | 118 Participants | 53 Participants | 17 Participants | 106 Participants |
| Insurance Adult Clinic Patients Eligible for CRC Screening Post-Implementation Commercial | 4414 Participants | 2880 Participants | 7294 Participants | — | — | — | — |
| Insurance Adult Clinic Patients Eligible for CRC Screening Post-Implementation Medicaid | 216 Participants | 203 Participants | 419 Participants | — | — | — | — |
| Insurance Adult Clinic Patients Eligible for CRC Screening Post-Implementation Medicare | 2627 Participants | 1648 Participants | 4275 Participants | — | — | — | — |
| Insurance Adult Clinic Patients Eligible for CRC Screening Post-Implementation Other | 273 Participants | 140 Participants | 413 Participants | — | — | — | — |
| Insurance Adult Clinic Patients Eligible for CRC Screening Post-Implementation Uninsured | 403 Participants | 288 Participants | 691 Participants | — | — | — | — |
| Insurance Adult Clinic Patients Eligible for CRC Screening Post-Implementation Unknown | 0 Participants | 0 Participants | 0 Participants | — | — | — | — |
| Insurance All Participants Commercial | 23666 Participants | 13028 Participants | 41740 Participants | 0 Participants | 2922 Participants | 2124 Participants | 0 Participants |
| Insurance All Participants Medicaid | 1783 Participants | 1587 Participants | 3624 Participants | 0 Participants | 141 Participants | 113 Participants | 0 Participants |
| Insurance All Participants Medicare | 14644 Participants | 6893 Participants | 24687 Participants | 0 Participants | 1857 Participants | 1293 Participants | 0 Participants |
| Insurance All Participants Other | 1374 Participants | 722 Participants | 2446 Participants | 0 Participants | 222 Participants | 128 Participants | 0 Participants |
| Insurance All Participants Uninsured | 2308 Participants | 1129 Participants | 4134 Participants | 0 Participants | 384 Participants | 313 Participants | 0 Participants |
| Insurance All Participants Unknown | 0 Participants | 0 Participants | 514 Participants | 232 Participants | 0 Participants | 0 Participants | 282 Participants |
| Race (NIH/OMB) Adult Clinic Patients Eligible for CRC Screening Post-Implementation American Indian or Alaska Native | 63 Participants | 44 Participants | 107 Participants | — | — | — | — |
| Race (NIH/OMB) Adult Clinic Patients Eligible for CRC Screening Post-Implementation Asian | 154 Participants | 99 Participants | 253 Participants | — | — | — | — |
| Race (NIH/OMB) Adult Clinic Patients Eligible for CRC Screening Post-Implementation Black or African American | 860 Participants | 704 Participants | 1564 Participants | — | — | — | — |
| Race (NIH/OMB) Adult Clinic Patients Eligible for CRC Screening Post-Implementation More than one race | 0 Participants | 0 Participants | 0 Participants | — | — | — | — |
| Race (NIH/OMB) Adult Clinic Patients Eligible for CRC Screening Post-Implementation Native Hawaiian or Other Pacific Islander | 12 Participants | 6 Participants | 18 Participants | — | — | — | — |
| Race (NIH/OMB) Adult Clinic Patients Eligible for CRC Screening Post-Implementation Unknown or Not Reported | 457 Participants | 213 Participants | 670 Participants | — | — | — | — |
| Race (NIH/OMB) Adult Clinic Patients Eligible for CRC Screening Post-Implementation White | 6387 Participants | 4093 Participants | 10480 Participants | — | — | — | — |
| Race (NIH/OMB) All Participants American Indian or Alaska Native | 319 Participants | 128 Participants | 527 Participants | 2 Participants | 55 Participants | 22 Participants | 1 Participants |
| Race (NIH/OMB) All Participants Asian | 930 Participants | 504 Participants | 1644 Participants | 4 Participants | 115 Participants | 86 Participants | 5 Participants |
| Race (NIH/OMB) All Participants Black or African American | 4490 Participants | 3329 Participants | 9058 Participants | 19 Participants | 656 Participants | 533 Participants | 31 Participants |
| Race (NIH/OMB) All Participants More than one race | 0 Participants | 0 Participants | 3 Participants | 1 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) All Participants Native Hawaiian or Other Pacific Islander | 46 Participants | 35 Participants | 98 Participants | 0 Participants | 13 Participants | 4 Participants | 0 Participants |
| Race (NIH/OMB) All Participants Unknown or Not Reported | 2448 Participants | 1077 Participants | 4240 Participants | 121 Participants | 341 Participants | 145 Participants | 108 Participants |
| Race (NIH/OMB) All Participants White | 35542 Participants | 18286 Participants | 61575 Participants | 85 Participants | 4346 Participants | 3181 Participants | 135 Participants |
| Sex/Gender, Customized Adult Clinic Patients Eligible for CRC Screening Post-Implementation Female | 4429 Participants | 2782 Participants | 7211 Participants | — | — | — | — |
| Sex/Gender, Customized Adult Clinic Patients Eligible for CRC Screening Post-Implementation Male | 3504 Participants | 2376 Participants | 5880 Participants | — | — | — | — |
| Sex/Gender, Customized Adult Clinic Patients Eligible for CRC Screening Post-Implementation Unknown | 0 Participants | 1 Participants | 1 Participants | — | — | — | — |
| Sex/Gender, Customized All Participants Female | 25823 Participants | 13530 Participants | 44948 Participants | 108 Participants | 3137 Participants | 2188 Participants | 162 Participants |
| Sex/Gender, Customized All Participants Male | 17952 Participants | 9828 Participants | 31983 Participants | 11 Participants | 2389 Participants | 1783 Participants | 20 Participants |
| Sex/Gender, Customized All Participants Unknown | 0 Participants | 1 Participants | 214 Participants | 113 Participants | 0 Participants | 0 Participants | 100 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk |
|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 7,933 | 0 / 5,159 | 0 / 43,775 | 0 / 23,359 | 0 / 282 | 0 / 232 | 0 / 5,526 | 0 / 3,971 |
| other Total, other adverse events | 0 / 7,933 | 0 / 5,159 | 0 / 43,775 | 0 / 23,359 | 0 / 282 | 0 / 232 | 0 / 5,526 | 0 / 3,971 |
| serious Total, serious adverse events | 0 / 7,933 | 0 / 5,159 | 0 / 43,775 | 0 / 23,359 | 0 / 282 | 0 / 232 | 0 / 5,526 | 0 / 3,971 |
Outcome results
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.
Time frame: Month 6
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Clinic Patients Eligible for CRC Screening on High Touch Strategy (Post-Implementation) | Percent of Patients Who Complete the mPATH-CRC Program | 5 Participants |
| Clinic Patients Eligible for CRC Screening on Low Touch Strategy (Post-Implementation) | Percent of Patients Who Complete the mPATH-CRC Program | 4 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.
Time frame: up to 16 weeks from index visit
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.
Time frame: Month 12 or month of discontinuation of mPATH use
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.
Time frame: month 6
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
Time frame: up to month 6
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.
Time frame: month 6
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.
Time frame: month 6
Secondary
mPATH-CheckIn Maintenance
The proportion of patients aged 18 or older who complete mPATH-CheckIn in months 7-12
Time frame: months 7-12
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
Time frame: up to month 6
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.
Time frame: month 6
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.
Time frame: up to month 6
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.
Time frame: month 6
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).
Time frame: up to 16 weeks from index visit
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.
Time frame: month 6
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
Time frame: up to month 6
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
Time frame: months 7-12
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
Time frame: Months 1-5
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)
Time frame: up to month 6