Emery J et al. 2007 "The GRAIDS trial: a cluster randomised controlled trial of computer decision support for the management of familial cancer risk in primary care."

Reference
Emery J, Morris H, Goodchild R, et al. The GRAIDS trial: a cluster randomised controlled trial of computer decision support for the management of familial cancer risk in primary care. Br J Cancer 2007;97(4):486-493.
Abstract
"The objective was to evaluate the effect of an assessment strategy using the computer decision support system (the GRAIDS software), on the management of familial cancer risk in British general practice in comparison with best current practice. The design included cluster randomised controlled trial, and involved forty-five general practice teams in East Anglia, UK. Randomised to GRAIDS (Genetic Risk Assessment on the Internet with Decision Support) support (intervention n = 23) or comparison (n = 22). Training in the new assessment strategy and access to the GRAIDS software (GRAIDS arm) was conducted, compared with an educational session and guidelines about managing familial breast and colorectal cancer risk (comparison) were mailed. Outcomes were measured at practice, practitioner and patient levels. The primary outcome measure, at practice level, was the proportion of referrals made to the Regional Genetics Clinic for familial breast or colorectal cancer that were consistent with referral guidelines. Other measures included practitioner confidence in managing familial cancer (GRAIDS arm only) and, in patients: cancer worry, risk perception and knowledge about familial cancer. There were more referrals to the Regional Genetics Clinic from GRAIDS than comparison practices (mean 6.2 and 3.2 referrals per 10 000 registered patients per year; mean difference 3.0 referrals; 95% confidence interval (CI) 1.2 - 4.8; P 0.001); referrals from GRAIDS practices were more likely to be consistent with referral guidelines (odds ratio (OR) 5.2; 95% CI 1.7 - 15.8, P 0.006). Patients referred from GRAIDS practices had lower cancer worry scores at the point of referral (mean difference - 1.44 95% CI - 2.64 to - 0.23, P 0.02). There were no differences in patient knowledge about familial cancer. The intervention increased GPs' confidence in managing familial cancer. Compared with education and mailed guidelines, assessment including computer decision support increased the number and quality of referrals to the Regional Genetics Clinic for familial cancer risk, improved practitioner confidence and had no adverse psychological effects in patients."
Objective

"To evaluate the effect of an assessment strategy using the computer decision support system ... on the management of familial cancer risk in British general practice in comparison with best current practice."

Tools Used
Type Clinic
Primary care
Type Specific
Family practice
Size
Small and/or medium
Other Information
The study involved 45 general practice teams in East Anglia, United Kingdom, each with at least three full-time equivalent physicians.
Type of Health IT
Decision support system
Type of Health IT Functions
"The [decision support system (DSS)] software links a user-friendly pedigree-drawing tool to patient-specific management advice regarding a family history of breast/ovarian and colorectal cancer, and provides additional numerical risk information about breast cancer... The software ... create[s] pedigrees [based on patient-provided data about family history of cancer] and assesses familial cancer risk using two parallel methods: the implementation of risk assessment guidelines and an epidemiological risk model." Regional guidelines were used, which "are principally designed to assess cancer risk and categorise people into increased risk or population risk; the familial breast/ovarian cancer guidelines additionally categorise women into moderate and high risk, the latter representing people who are also at clinically significant risk of carrying a BRCA1/2 mutation." Patients judged to have increased risk were referred to a Regional Genetics Clinic for further testing.
Workflow-Related Findings
"A significantly higher proportion of referral letters was consistent with the regional guidelines in the intervention arm than in the comparison arm (breast cancer alone and breast and colorectal cancer combined...)." But the Regional Genetics Clinic found an increased risk of cancer for the same proportion of referred patients in the intervention and control groups because the guidelines for colorectal cancer screening led to more low-risk patients being tested.
"Lead clinicians' confidence in managing people with a family history of cancer increased significantly after training and this increase was maintained at 12 months...Their attitudes towards the software were generally positive, such that it was felt to be simple, easy, beneficial and cost-effective and these positive attitudes remained at 12 months...However, there was some reduction over time, in agreement with the statement that the software enhanced consultations ... and persistent agreement that it would prolong consultations...All but one lead clinician intended to continue using the software if it remained available."
Study Design
Randomized controlled trial (RCT)
Study Participants
Practices were randomly assigned to use the decision support system (DSS)-based or non-DSS best practices. "Patients were invited to participate if they expressed concerns about their family history of breast or colorectal cancer in a consultation."