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Lack of sufficient participants meeting the eligibility criteria to complete study in proposed and acceptable time frame.
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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 preventative screenings for those patients who, based on national quality standards, have become newly eligible for screening measures. We hypothesize that educational outreach may increase completion rates.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual Care | No Intervention | Usual Care. Participants in this arm will receive Usual care until outcome assessment is performed at 6 months following randomization. At that time, they will be sent a letter reminding them to obtain the ordered preventative service test, however no further outcomes will be assessed. Thus, during the course of the study, all participants in this arm will have solely received usual care. | |
| Behavioral: Letter Only | Experimental | Behavioral: Letter Only Prior to a scheduled upcoming appointment, participants will get a letter signed by their physician that provides brief information about colorectal cancer (CRC) and notes the importance of CRC screening. |
|
| Behavioral: Letter and Educational DVD | Experimental | Behavioral: Letter and Educational DVD Participants will get a letter from their physician that provides brief information about colorectal cancer (CRC) and notes the importance of CRC screening. It will be accompanied by an educational DVD about the screening. The participants will receive this prior to a scheduled upcoming appointment with their physician. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Letter Only | Behavioral | Prior to a scheduled upcoming appointment, participants will get a letter signed by their physician that provides brief information about colorectal cancer (CRC) and notes the importance of CRC screening. |
| Measure | Description | Time Frame |
|---|---|---|
| Completion of CRC Screening | What would have been reported as this Outcome Measure is the number of participants who completed screening. We planned to review electronic health records of participants 6 months post randomization to look for either: (1) note in free text MD note documenting receipt of one form of colorectal cancer (CRC) screening during study period or (2)lab results from fecal occult blood test, sigmoidoscopy, or colonoscopy. Screening completion equaled presence of a lab result or physician note in chart. No patient charts were reviewed due to low accrual. | 6 months from initial contact |
| Measure | Description | Time Frame |
|---|---|---|
| The Secondary Outcome for the Study is the Time to Screening Completion. | This Outcome Measure would have reported the length of time, measured in days, that occurred between the date of randomization and the completed screening date. We planned to review the electronic health records of participants 6 months post randomization to look for either: (1)note in free text MD note documenting receipt of one form of CRC screening during study period or (2)lab results from fecal occult blood test, sigmoidoscopy, or colonoscopy. Screening completion equaled presence of a lab result or physician note in chart. No patient charts were reviewed due to low accrual. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kenzie Cameron, PhD | Northwestern University, Department of General Internal Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern Medical Faculty Foundation General Internal Medicine Clinic | Chicago | Illinois | 60611 | United States |
We used data contained in the clinic's electronic health record to identify eligible patients. All eligible patients were randomly assigned to one of the three study arms.
The trial took place at a large urban academic primary care internal medicine practice in Chicago, IL. The trial enrolled patients between March and December 2009.
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| ID | Title | Description |
|---|---|---|
| FG000 | Usual Care | Usual Care. Participants in this arm will receive usual care until outcome assessment is performed at 6 months following randomization. At that time, they will be sent a letter reminding them to obtain the ordered preventative service test. |
| FG001 | Behavioral: Letter Only | Behavioral: Letter Only Prior to a scheduled upcoming appointment, participants will get a letter signed by their physician that provides brief information about colorectal cancer (CRC) and notes the importance of CRC screening. |
| FG002 | Behavioral: Letter and Educational DVD | Behavioral: Letter and Educational DVD Participants will get a letter from their physician that provides brief information about colorectal cancer (CRC) and notes the importance of CRC screening. It will be accompanied by an educational DVD about the screening. The participants will receive this prior to a scheduled upcoming appointment with their physician. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Usual Care | Usual Care. Participants in this arm will receive usual care until outcome assessment is performed at 6 months following randomization. At that time, they will be sent a letter reminding them to obtain the ordered preventative service test. |
| BG001 | Behavioral: Letter Only |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | The Secondary Outcome for the Study is the Time to Screening Completion. | This Outcome Measure would have reported the length of time, measured in days, that occurred between the date of randomization and the completed screening date. We planned to review the electronic health records of participants 6 months post randomization to look for either: (1)note in free text MD note documenting receipt of one form of CRC screening during study period or (2)lab results from fecal occult blood test, sigmoidoscopy, or colonoscopy. Screening completion equaled presence of a lab result or physician note in chart. No patient charts were reviewed due to low accrual. | Although 60 individuals were randomized to condition, the trial was halted prior to primary or secondary outcome chart reviews. Hence there are no results to report. | Posted | Number | participants | 6 months after randomization |
|
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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 | Usual Care | Usual Care. Participants in this arm will receive usual care until outcome assessment is performed at 6 months following randomization. At that time, they will be sent a letter reminding them to obtain the ordered preventative service test. |
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Early termination prior to collection of primary or secondary outcome measures, hence no analyses of the primary or secondary outcomes were performed.Thus, the only results reported are baseline characteristics of enrolled participants.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kenzie A. Cameron, PhD, MPH | Northwestern University, Department of General Internal Medicine | 312-503-3910 | K-Cameron@northwestern.edu |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| Letter and Educational DVD | Behavioral | Participants will get a letter from their physician that provides brief information about colorectal cancer (CRC) and notes the importance of CRC screening. It will be accompanied by an educational DVD about the screening. The participants will receive this prior to a scheduled upcoming appointment with their physician. |
|
| 6 months after randomization |
Behavioral: Letter Only Prior to a scheduled upcoming appointment, participants will get a letter signed by their physician that provides brief information about colorectal cancer (CRC) and notes the importance of CRC screening. |
| BG002 | Behavioral: Letter and Educational DVD | Behavioral: Letter and Educational DVD Participants will get a letter from their physician that provides brief information about colorectal cancer (CRC) and notes the importance of CRC screening. It will be accompanied by an educational DVD about the screening. The participants will receive this prior to a scheduled upcoming appointment with their physician. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Usual Care - participants receive usual care
| OG001 | Behavioral: Letter Only | Participants in this arm will receive a letter signed by their physician that provides brief information about colorectal cancer (CRC) and notes the importance of CRC screening. |
| OG002 | Behavioral: Letter and Educational DVD | Participants will get a letter from their physician that provides brief information about colorectal cancer (CRC) and notes the importance of CRC screening. It will be accompanied by an educational DVD about the screening. The participants will receive this prior to a scheduled upcoming appointment with their physician. |
|
|
| Primary | Completion of CRC Screening | What would have been reported as this Outcome Measure is the number of participants who completed screening. We planned to review electronic health records of participants 6 months post randomization to look for either: (1) note in free text MD note documenting receipt of one form of colorectal cancer (CRC) screening during study period or (2)lab results from fecal occult blood test, sigmoidoscopy, or colonoscopy. Screening completion equaled presence of a lab result or physician note in chart. No patient charts were reviewed due to low accrual. | Although 60 individuals were randomized to condition, the trial was halted prior to primary or secondary outcome chart reviews. Hence there are no results to report. | Posted | Number | participants | 6 months from initial contact |
|
|
|
| 0 |
| 21 |
| 0 |
| 21 |
| EG001 | Behavioral: Letter Only | Behavioral: Letter Only Prior to a scheduled upcoming appointment, participants will get a letter signed by their physician that provides brief information about colorectal cancer (CRC) and notes the importance of CRC screening. | 0 | 18 | 0 | 18 |
| EG002 | Behavioral: Letter and Educational DVD | Behavioral: Letter and Educational DVD Participants will get a letter from their physician that provides brief information about colorectal cancer (CRC) and notes the importance of CRC screening. It will be accompanied by an educational DVD about the screening. The participants will receive this prior to a scheduled upcoming appointment with their physician. | 0 | 21 | 0 | 21 |
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| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |