NCT01468675

Brief Summary

We evaluated whether collection of risk factors to generate an electronic health record (EHR)-linked personalized health risk appraisal (HRA) for coronary heart disease (CHD), diabetes, breast and colorectal cancer (CRC) was associated with improved patient-provider communication, risk assessment, and breast cancer screening plans in the next year.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6,075

participants targeted

Target at P75+ for not_applicable colorectal-cancer

Timeline
Completed

Started Feb 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 4, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 9, 2011

Completed
1.2 years until next milestone

Study Start

First participant enrolled

February 1, 2013

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
2.4 years until next milestone

Results Posted

Study results publicly available

April 28, 2017

Completed
Last Updated

April 28, 2017

Status Verified

March 1, 2017

Enrollment Period

1.8 years

First QC Date

November 4, 2011

Results QC Date

December 21, 2016

Last Update Submit

March 20, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Number of Subjects Who Discussed Disease Risk With Primary Care Provider

    3 months following primary care visit

Study Arms (2)

Intervention

EXPERIMENTAL

The intervention is completion of a validated, web-based risk assessment used to assess personalized risk and generate a risk report

Other: Intervention

Control

NO INTERVENTION

Usual Care

Interventions

risk assessment survey; decision support for providers for prevention based on risk

Also known as: Risk Assessment and Prevention Recommendations
Intervention

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults 18 - 75 Years old
  • English or Spanish speaking
  • Recent visit to a participating primary care practice

You may not qualify if:

  • No phone number or email address listed in the EHR

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02120, United States

Location

MeSH Terms

Conditions

Colorectal NeoplasmsBreast NeoplasmsCoronary DiseaseDiabetes Mellitus

Interventions

MethodsRisk Assessment

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Investigative TechniquesRiskProbabilityStatistics as TopicEpidemiologic MethodsRisk ManagementOrganization and AdministrationHealth Services AdministrationHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Results Point of Contact

Title
Jennifer Haas, M.D.
Organization
Brigham and Women's Hospital

Study Officials

  • Jennifer Haas, MD

    Brigham and Women's Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

November 4, 2011

First Posted

November 9, 2011

Study Start

February 1, 2013

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

April 28, 2017

Results First Posted

April 28, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share

Locations