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| Name | Class |
|---|---|
| Agency for Healthcare Research and Quality (AHRQ) | FED |
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The purpose of this study is to evaluate whether patient outreach is effective at increasing compliance with preventive screenings ordered by their physician. We hypothesize that educational outreach may increase completion rates.
We designed an intervention to focus on patients who have received and accepted a referral for colonoscopy, yet have exhibited some barriers to screening as demonstrated by a lack of screening completion. We conducted a randomized controlled trial to assess the effects of a multicomponent intervention (patient reminder, print and multimedia materials) on colorectal screening completion among this target population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group | Experimental | Received Educational Outreach |
|
| Usual Care Control Group | No Intervention | Participants in this arm will receive normal care until outcome assessment is performed at 6 months following the placement of the order for the preventive service. They will be sent a letter reminding them to obtain the ordered preventive service test. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Educational outreach | Behavioral | Participants will get a letter from their physician that explains that their records show the test has not been completed. The letter will be mailed along with an educational brochure and a DVD about colorectal cancer and colorectal cancer screening. |
| Measure | Description | Time Frame |
|---|---|---|
| Colorectal Cancer Screening Completion. | We reviewed electronic health records of participants 3 months post randomization to ascertain outcome. We looked for one or both of the following (1) note in free text MD note documenting receipt of one form of colorectal cancer (CRC) screening during study period (2)lab results from fecal occult blood test, sigmoidoscopy, or colonoscopy. Participants were categorized as completing CRC screening if there was a lab result or physician note located in chart during study period. If no note or lab result was found in chart, then the participant was categorized as not completing CRC screening. | 3 months post randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Colorectal Cancer Screening Completion | We reviewed electronic health records of participants 6 months post randomization to ascertain outcome. We looked for one or both of the following (1) note in free text MD note documenting receipt of one form of colorectal cancer (CRC) screening during study period (2)lab results from fecal occult blood test, sigmoidoscopy, or colonoscopy. Participants were categorized as completing CRC screening if there was a lab result or physician note located in chart during study period. If no note or lab result was found in chart, then the participant was categorized as not completing CRC screening. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kenzie A Cameron, PhD, MPH | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern Medical Faculty Foundation General Internal Medicine Clinic | Chicago | Illinois | 60611 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21149742 | Result | Cameron KA, Persell SD, Brown T, Thompson J, Baker DW. Patient outreach to promote colorectal cancer screening among patients with an expired order for colonoscopy: a randomized controlled trial. Arch Intern Med. 2011 Apr 11;171(7):642-6. doi: 10.1001/archinternmed.2010.468. Epub 2010 Dec 13. |
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We used data contained in the clinic's electronic health record to identify eligible patients. All eligible patients were randomly assigned in equal numbers to either the control or intervention arms. All eligible patients were randomized and assigned to groups until we reached target study size.
This trial took place at a large urban academic primary care internal medicine practice in Chicago, IL. This trial was enrolling patients between October 2008 and May 2009.
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention Group | Participants assigned to this group received a one-time educational intervention within one week of randomization. Educational intervention consisted of a letter from patient's physician, a brochure about colorectal cancer screening, and a DVD about colorectal cancer screening. |
| FG001 | Usual Care Control Group | Participants in this arm will receive normal care until outcome assessment is performed at 6 months following the placement of the order for the preventive service. They will be sent a letter reminding them to obtain the ordered preventive service test. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention Group | Participants assigned to this group received a one-time educational intervention within one week of randomization. Educational intervention consisted of a letter from patient's physician, a brochure about colorectal cancer screening, and a DVD about colorectal cancer screening. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| 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 | Colorectal Cancer Screening Completion. | We reviewed electronic health records of participants 3 months post randomization to ascertain outcome. We looked for one or both of the following (1) note in free text MD note documenting receipt of one form of colorectal cancer (CRC) screening during study period (2)lab results from fecal occult blood test, sigmoidoscopy, or colonoscopy. Participants were categorized as completing CRC screening if there was a lab result or physician note located in chart during study period. If no note or lab result was found in chart, then the participant was categorized as not completing CRC screening. | Analysis was based on intention to treat. | Posted | Number | participants | 3 months post randomization |
|
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This was a minimal risk trial assessing an educational intervention which was approved by our Institutional Review Board with a waiver of consent. Serious and/or other adverse events were not collected or assessed.
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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 | Intervention Group | Participants assigned to this group received a one-time educational intervention within one week of randomization. Educational intervention consisted of a letter from patient's physician, a brochure about colorectal cancer screening, and a DVD about colorectal cancer screening. |
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This study does not identify the timing of the intervention that would have the most impact. Mailings occurred 3 months or more after the order was placed, contacting patients sooner may have been more effective.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kenzie A. Cameron, PhD, MPH | Northwestern University | 312-503-3910 | k-cameron@northwestern.edu |
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|
| 6 months post randomization |
| Usual Care Control Group |
Participants in this arm will receive normal care until outcome assessment is performed at 6 months following the placement of the order for the preventive service. They will be sent a letter reminding them to obtain the ordered preventive service test. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
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| Number of visits in past 2 years | Number | Participants |
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| Colorectal Cancer (CRC) screening history | Number | Participants |
|
| Insurance Status | Number | Participants |
|
| OG001 |
| Intervention Group |
Received Educational Outreach |
|
|
|
| Secondary | Colorectal Cancer Screening Completion | We reviewed electronic health records of participants 6 months post randomization to ascertain outcome. We looked for one or both of the following (1) note in free text MD note documenting receipt of one form of colorectal cancer (CRC) screening during study period (2)lab results from fecal occult blood test, sigmoidoscopy, or colonoscopy. Participants were categorized as completing CRC screening if there was a lab result or physician note located in chart during study period. If no note or lab result was found in chart, then the participant was categorized as not completing CRC screening. | Analysis was based on intention to treat. | Posted | Number | participants | 6 months post randomization |
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|
|
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Usual Care Control Group | Participants in this arm will receive normal care until outcome assessment is performed at 6 months following the placement of the order for the preventive service. They will be sent a letter reminding them to obtain the ordered preventive service test. | 0 | 0 | 0 | 0 |
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