Trial · NCT04514341
Implementing a Multilevel Intervention to Accelerate Colorectal Cancer Screening and Follow-up
NCT04514341, Completed, Milton S. Hershey Medical Center; results first posted 2026-01-14
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Implementing a Multilevel Intervention to Accelerate Colorectal Cancer Screening and Follow-up. Trials, record NCT04514341. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04514341
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Implementing a Multilevel Intervention to Accelerate Colorectal Cancer Screening and Follow-up
- NCT number
- NCT04514341
- Status
- Completed
- Enrollment
- 4 participants, actual
- Lead sponsor
- Milton S. Hershey Medical Center
- Conditions
- Colorectal Cancer
- Interventions
Intervention Phase 1: Provider and Staff education, Intervention Phase 2: Provider and staff education + Patient reminder, Intervention Phase 3: Provider and Staff education + Patient reminder + Patient navigation
- First posted
- 2020-08-14
- Last updated
- 2026-01-14
- Results first posted
- 2026-01-14
- Limitations and caveats
Relevant colorectal screening data, including up-to-date screening rates, screening order rates, and completion rates, were extracted from the electronic health records. However, each participating federally qualified health center used a different EMR system, and the capability to extract relevant data was sometimes limited by the system in use, particularly in one of the participating FQHCs, which used an older system and was unable to extract some data elements successfully.
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | CRC Screening Rate | From date of randomization until the last subject completed the study. This could have been up to 36 months. | The number of patients aged 50-75 years who were up-to-date with colorectal cancer screening during each implementation phase. |
| Primary | CRC Screening Ordering Rate | From date of randomization until the date subject completed the study. This could have been up to 36 months. | The number of patients between the ages of 50 and 75 who needed CRC screening and received a screening order (excluding participants who received an order but have already been up to date with screening ) during each implementation phase. |
| Primary | CRC Screening Completion Rate | From date of randomization until the date subject completed the study. This could have been up to 36 months. | The number of patients between the ages of 50 and 75 who needed CRC screening, received an order for screening, and completed the screening during each implementation phase. |
| Secondary | Provider Education Participation | From the date of the first education session until the completion of the last education sessions. This could have been up to 24 months. | The number of providers who attended the annual education sessions during Phase 1 and Phase 2. To accommodate the COVID-19 restrictions, all sessions were delivered via Zoom, with multiple sessions scheduled within each FQHC based on clinic availability. Both groups received the education component simultaneously, with no delay in implementation. |
| Secondary | Patient Reminder Enrollment | From the initiation of the SMS reminder system until the last participant enrolled. This could have been up to 30 months. | The number of participants who received a FIT or colonoscopy order (excluding Cologuard, which provides its own reminder services) and subsequently enrolled in the short message service (SMS) reminder system during Phase 2 and Phase 3. The SMS platform was used to engage participants and remind them to complete their screenings; participants could opt out at any time by replying "STOP". |
| Secondary | Impact of Remote Patient Navigation Services | From the navigation service initiated at the partner FQHC until the completion of the study, assessed up to 16 months. | The number of participants who received remote navigation services (phone-based navigation) during Phase 3 and subsequently completed their screenings. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | CRC Screening Rate | From date of randomization until the last subject completed the study. This could have been up to 36 months. | The overall number represents all participants across all study phases. The number analyzed reflects only participants contributing data at the reported phase. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | CRC Screening Ordering Rate | From date of randomization until the date subject completed the study. This could have been up to 36 months. | The overall number represents all participants who needed screening across all study Phases. The number analyzed reflects only participants contributing data at the reported phase. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | CRC Screening Completion Rate | From date of randomization until the date subject completed the study. This could have been up to 36 months. | The overall number represents all participants who needed CRC screening and received an order across all study phases. The number analyzed reflects only participants contributing data at the reported milestone. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Provider Education Participation | From the date of the first education session until the completion of the last education sessions. This could have been up to 24 months. | The overall number represents the total number of providers invited to the education sessions during Phase 1 and Phase 2. The number analyzed reflects the number of providers invited to the education sessions during the reported phase. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Patient Reminder Enrollment | From the initiation of the SMS reminder system until the last participant enrolled. This could have been up to 30 months. | The overall number represents the total number of participants who received a FIT or colonoscope order during the implementation of Phase 1 and Phase 2. The number analyzed reflects only the number of participants contributing data to the reported milestone. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Impact of Remote Patient Navigation Services | From the navigation service initiated at the partner FQHC until the completion of the study, assessed up to 16 months. | The overall number represents the number of participants whom the navigators successfully contacted and spoke to during Phase 3. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group28
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| CRC Screening Rate | Group 1 | Phase 1: Provider and Staff Education | 8611 | Participants | |
| CRC Screening Rate | Group 2 | Phase 1: Provider and Staff Education | 3989 | Participants | |
| CRC Screening Rate | Group 1 | Phase 2: Provider Education + Patient Reminder | 9438 | Participants | |
| CRC Screening Rate | Group 2 | Phase 2: Provider Education + Patient Reminder | 3186 | Participants | |
| CRC Screening Rate | Group 1 | Phase 3: Provider and Staff Education + Patient Reminders + Remote Patient Navigation | 10720 | Participants | |
| CRC Screening Rate | Group 2 | Phase 3: Provider and Staff Education + Patient Reminders + Remote Patient Navigation | 3303 | Participants | |
| CRC Screening Ordering Rate | Group 1 | Phase 1: Provide and Staff Education | 7012 | Participants | |
| CRC Screening Ordering Rate | Group 2 | Phase 1: Provide and Staff Education | 5087 | Participants | |
| CRC Screening Ordering Rate | Group 1 | Phase 2: Provider and Staff Education + Patient Reminders | 6458 | Participants | |
| CRC Screening Ordering Rate | Group 2 | Phase 2: Provider and Staff Education + Patient Reminders | 4757 | Participants |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 results by groupParticipant flow48
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Baseline (Months 0-12) | STARTED | Group 1 | 18,099 | 2 |
| Baseline (Months 0-12) | STARTED | Group 2 | 20,834 | 2 |
| Baseline (Months 0-12) | Group 1 and Group 2 collect baseline data only, no intervention | Group 1 | 18,099 | 2 |
| Baseline (Months 0-12) | Group 1 and Group 2 collect baseline data only, no intervention | Group 2 | 20,834 | 2 |
| Baseline (Months 0-12) | COMPLETED | Group 1 | 18,099 | 2 |
| Baseline (Months 0-12) | COMPLETED | Group 2 | 20,834 | 2 |
| Baseline (Months 0-12) | NOT COMPLETED | Group 1 | 0 | 0 |
| Baseline (Months 0-12) | NOT COMPLETED | Group 2 | 0 | 0 |
| Step 1 (Months 13-18) | STARTED | Group 1 | 19,318 | 2 |
| Step 1 (Months 13-18) | STARTED | Group 2 | 18,878 | 2 |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 participant flowAdverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals24
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Group 1 During Phase 0 (No Intervention) | 0 | 18,099 |
| Total, all-cause mortality | Group 2 During Phase 0 (No Intervention) | 0 | 20,834 |
| Total, all-cause mortality | Groups 1 During Phase 1 | 0 | 19,318 |
| Total, all-cause mortality | Groups 2 During Phase 1 | 0 | 18,878 |
| Total, all-cause mortality | Group 1 During Phase 2 | 0 | 21,102 |
| Total, all-cause mortality | Group 2 During Phase 2 | 0 | 15,725 |
| Total, all-cause mortality | Group 1 During Phase 3 | 0 | 21,602 |
| Total, all-cause mortality | Group 2 During Phase 3 | 0 | 15,037 |
| Total, other adverse events | Group 1 During Phase 0 (No Intervention) | 0 | 18,099 |
| Total, other adverse events | Group 2 During Phase 0 (No Intervention) | 0 | 20,834 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 33121536 | DERIVED |
Source PubMed
Grants2
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|---|---|---|---|---|---|
| UH3CA233229 | ACCISIS-Chicago | KIM, KAREN E; POLITE, BLASE N. | PENNSYLVANIA STATE UNIV HERSHEY MED CTR | NATIONAL CANCER INSTITUTE | 2019 to 2022 | NIH RePORTER |
| UG3CA233229 | ACCISIS-Chicago | KIM, KAREN E; POLITE, BLASE N. | UNIVERSITY OF CHICAGO | NATIONAL CANCER INSTITUTE | 2018 | NIH RePORTER |
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Group 1 vs Group 2: Impact of Remote Patient Navigation Services |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04514341
GET https://conductscience.org/api/trials/v1/NCT04514341/results?page=2