Trial Outcomes & Findings for Health Information Technology (HIT) Enhanced Family History Documentation and Management in Primary Care (NCT NCT01468675)
NCT ID: NCT01468675
Last Updated: 2017-04-28
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
6075 participants
Primary outcome timeframe
3 months following primary care visit
Results posted on
2017-04-28
Participant Flow
Participant milestones
| Measure |
Intervention
Risk Assessment and Prevention Recommendations
|
Control
Control - Usual Care
|
|---|---|---|
|
Overall Study
STARTED
|
2699
|
3376
|
|
Overall Study
COMPLETED
|
1699
|
2004
|
|
Overall Study
NOT COMPLETED
|
1000
|
1372
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Health Information Technology (HIT) Enhanced Family History Documentation and Management in Primary Care
Baseline characteristics by cohort
| Measure |
Intervention
n=1699 Participants
Risk Assessment and Prevention Recommendations provided to subjects
|
Control
n=2004 Participants
Usual Care
|
Total
n=3703 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55 years
n=5 Participants
|
56 years
n=7 Participants
|
55 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
1338 Participants
n=5 Participants
|
1415 Participants
n=7 Participants
|
2753 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
361 Participants
n=5 Participants
|
589 Participants
n=7 Participants
|
950 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
white
|
1418 participants
n=5 Participants
|
1675 participants
n=7 Participants
|
3093 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
black
|
79 participants
n=5 Participants
|
82 participants
n=7 Participants
|
161 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Latino
|
91 participants
n=5 Participants
|
105 participants
n=7 Participants
|
196 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other/ unknown
|
111 participants
n=5 Participants
|
142 participants
n=7 Participants
|
253 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
1699 participants
n=5 Participants
|
2004 participants
n=7 Participants
|
3703 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 months following primary care visitPopulation: 1673+1847 (Total=3520) is the total number of subjects who answered the question that this outcome is derived from. (During your last doctor visit, did you talk to your PCP about your risk of developing cancer, heart disease or diabetes.) The total number of subjects included in the analysis is 3703.
Outcome measures
| Measure |
Intervention
n=1673 Participants
Validated, web-based risk assessment is being used to assess personalized risk and generate a risk report
risk assessment survey; decision support for providers for prevention based on risk
|
Control
n=1847 Participants
Usual care
|
|---|---|---|
|
Number of Subjects Who Discussed Disease Risk With Primary Care Provider
|
905 Participants
|
841 Participants
|
Adverse Events
Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place