Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| White River Junction Veterans Affairs Medical Center | FED |
Not provided
Not provided
Not provided
Fecal immunochemical tests (FIT) are a primary method of screening for colorectal cancer (CRC). Implementation intention planning involves encouraging completion or eliminating barriers for the participant to make a plan to complete a behavior or activity. This randomized control study seeks to answer whether the addition of an implementation intention guide impacts behaviors when completing FIT screening. The primary objective includes determining if the implementation intention guide increases completion rate of screening FIT. The secondary objectives is whether this intervention decreases the lab sample rejection rate and reduces the duration between sample collection and laboratory receipt/evaluation of screening FIT.
Colorectal cancer (CRC) has a high incidence, burden of disease, and significant associated mortality.(1,2) Programs to screen for CRC have leveraged stool testing with the fecal immunochemical test (FIT), a non-invasive at home test with no inherent risks, as the primary method in many countries.(3) Advantages of screening with FIT include considerations of safety, simplicity, and cost. However, while this and other options are available for colorectal cancer screening, patient screening rates have still not achieved recommended 70-80% targets.(4) In order to increase colorectal cancer screening rates, various behavioral interventions (including screening reminders, mailed screening outreach, choice architecture) have been implemented with success.(5,6)
Implementation intention planning involves encouraging or eliminating barriers for the participant to make a plan and complete FIT. Prior examples found that touchscreen implementation intention planning increased CRC screening completion by 12%.(7) For FOBT specifically, implementation intention planning instructions increased completion by 1.2-6.6%.(8) However, pre-written tips about FIT related to barriers did not increase FIT completion.(9)
This study seeks to understand the impact of a simple implementation intention planning guide (one-page piece of paper) on increasing rates of successful completion of FIT for colorectal cancer screening. The implementation intention planning guide is a one-page document that encourages the patient to make concrete plans about completing FIT. This study will evaluate if this low-cost intervention improves the rate of successful completion and reduces the duration between sample collection and lab result.
While some versions of implementation intention planning for CRC screening have been evaluated and shown positive impact in CRC screening completion, this study is hoping to build on these findings to evaluate a simplified implementation intention guide for patients specific to FIT. If this intervention is found to improve completion, these significant findings would support future FIT programs with a simple intervention to improve community screening rates. If these interventions do not improve completion, this research will inform the need to pursue investment in evaluating other interventions to improve FIT screening rates.
Aim 1: To determine if inclusion of implementation intention guide in FIT increases 90-day completion rate of screening FIT.
Hypothesis 1: The inclusion of implementation intention guide in FIT will increase the 90-day completion rate of screening FIT by 7%.
Aim 2: To determine if inclusion of implementation intention guide with FIT reduces the duration between sample collection and laboratory receipt/evaluation of screening FIT.
Hypothesis 2: The inclusion of implementation intention guide in FIT will reduce the duration between sample collection and laboratory receipt/evaluation by 20% in number of days and increase the number of samples received in the clinically appropriate time window of screening FIT (reducing the sample rejection rate) by 20%.
References:
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Arm (FIT Standard of Care) | No Intervention | The Control Arm will receive the fecal immunochemical test (FIT) standard of care. Participants in this arm will be evaluated by their ordering provider about their eligibility and appropriateness for FIT for colorectal cancer screening. If appropriate, these participants will receive the FIT, instructions, and any other documentations always provided to participants receiving FIT in clinical practice. Any follow-up materials or communications with their provider will also follow FIT standard of care. They will not receive any additional document/implementation intention guide with their FIT. | |
| Intervention Arm (FIT Standard of Care with Implementation Intention Guide) | Experimental | The Intervention Arm will receive the fecal immunochemical test (FIT) standard of care and the implementation intention guide one-page document. Participants in this arm will be evaluated by their ordering provider about their eligibility and appropriateness for FIT for colorectal cancer screening. If appropriate, these participants will receive the FIT, instructions, and any other documentations always provided to participants receiving FIT in clinical practice. They will also receive the implementation intention guide being evaluated in this study. Any follow-up materials or communications with their provider will also follow FIT standard of care. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Implementation Intention Guide | Behavioral | The intervention is the addition of implementation intention guide document provided with the FIT. This is a one-page piece of paper that was developed by the investigator team and finalized with input/feedback from patient partners. The implementation intention guide includes instructions about the importance of developing a plan to complete FIT. It also includes fillable fields for participants to enter their plan for when to complete, where to store, when to return, and where to return their FIT. Participants will also be able to follow a QR code on the implementation intention guide document to a link to complete an anonymous, electronic version of the guide and share feedback on the intervention. |
| Measure | Description | Time Frame |
|---|---|---|
| FIT completion rate | Percentage of participants who have completed, returned, and have received completed lab results for FIT 90 days following participant reception of FIT. | Through study completion, approximately 12-18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Duration between FIT collection date and receipt by the laboratory | Number of days from the participant FIT collection date (as reported by the participant on the FIT collection bottle) to the date the lab received the participant's FIT. | Through study completion, approximately 12-18 months |
| Rate of lab sample rejection |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Audrey H Calderwood, MD, MS | Contact | 603-650-5261 | Audrey.H.Calderwood@hitchcock.org | |
| Timothy McAuliffe, BA | Contact | timothy.john.mcauliffe@gmail.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dartmouth Hitchcock Clinics, Heater Road Primary Care | Lebanon | New Hampshire | 03766 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Participants will be grouped into intervention and control groups based on alternating weeks/months when they obtain their FIT throughout the study. These timelines will be designated before the initiation of the study with appropriate frequency of alternation to reduce variability between non-study conditions between the weeks/months.
Not provided
Not provided
Not provided
Not provided
|
Percentage of FIT samples rejected from the lab to not be appropriate for further evaluation (e.g., incorrect sampling/storage, expired test) |
| Through study completion, approximately 12-18 months |
| Dartmouth-Hitchcock Medical Center, General Internal Medicine Clinic | Lebanon | New Hampshire | 03766 | United States |
|
| Dartmouth Hitchcock Clinics, Lyme Primary Care Clinic | Lyme | New Hampshire | 03768 | United States |
|
| White River Junction Veterans Affairs Medical Center, Primary Care Clinic | White River Junction | Vermont | 05009 | United States |
|
| White River Junction Veterans Affairs Medical Center, VA Mailed FIT Program | White River Junction | Vermont | 05009 | United States |
|