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2.  An Application of a Modified Constrained Randomization Process to a Practice-Based Cluster Randomized Trial to Improve Colorectal Cancer Screening 
Contemporary clinical trials  2008;30(2):129-132.
Background
When designing cluster randomized trials, it is important for researchers to be familiar with strategies to achieve valid study designs given limited resources. Constrained randomization is a technique to help ensure balance on pre-specified baseline covariates.
Methods
The goal was to develop a randomization scheme that balanced 16 intervention and 16 control practices with respect to 7 factors that may influence improvement in study outcomes during a 4-year cluster randomized trial to improve colorectal cancer screening within a primary care practice-based research network. We used a novel approach that included simulating 30,000 randomization schemes, removing duplicates, identifying which schemes were sufficiently balanced, and randomly selecting one scheme for use in the trial. For a given factor, balance was considered achieved when the frequency of each factor’s sub-classifications differed by no more than 1 between intervention and control groups. The population being studied includes approximately 32 primary care practices located in 19 states within the U.S. that care for approximately 56,000 patients at least 50 years old.
Results
Of 29,782 unique simulated randomization schemes, 116 were determined to be balanced according to pre-specified criteria for all 7 baseline covariates. The final randomization scheme was randomly selected from these 116 acceptable schemes.
Conclusions
Using this technique, we were successfully able to find a randomization scheme that allocated 32 primary care practices into intervention and control groups in a way that preserved balance across 7 baseline covariates. This process may be a useful tool for ensuring covariate balance within moderately large cluster randomized trials.
doi:10.1016/j.cct.2008.10.002
PMCID: PMC2680348  PMID: 18977314
Randomization techniques; cluster randomized trials; covariate balance; study design; practice based research networks; colorectal cancer screening
3.  High Performance in Screening for Colorectal Cancer: A Practice Partner Research Network (PPRNet) Case Study 
Introduction
Colorectal cancer (CRC) screening is recommended for average risk adults age 50 and older, yet half of eligible US adults are not current. Competing demands within primary care suggest a systematic process is needed for improvement. This case study of highest performing practices within the Colorectal Screening in Primary Care study (C-TRIP) explains practice strategies used and provides a model for improving CRC screening in primary care.
Methods
A case study design was used to analyze practice performance data and qualitative data obtained from site visits, network meetings and correspondence. The Practice Partner Research Network (PPRNet) Translating Research into Practice (TRIP) Quality Improvement (QI) model provided an analytic framework to evaluate five highest performing practices in the C-TRIP intervention. Practice strategies were grouped within the concepts: prioritize performance (PP), redesign delivery system (RDS), electronic medical record tools (EMR), and activate the patient (AP).
Results
Thirteen specific practice strategies were exemplified within these four concepts (PP, RDS, EMR, AP). Most or all of these strategies were used by the practices that achieved a rate of up to 78% of adults screened for CRC.
Conclusions
Primary care practices achieving a high proportion of CRC screening use systematic processes in the organization of their care. This case study provides a framework to organize systems that increase early detection and prevention of colorectal cancer.
doi:10.3122/jabfm.2009.02.080108
PMCID: PMC2696281  PMID: 19264937
colorectal cancer screening; primary care; quality improvement; practice-based research
4.  Implementing change in primary care practices using electronic medical records: a conceptual framework 
Background
Implementing change in primary care is difficult, and little practical guidance is available to assist small primary care practices. Methods to structure care and develop new roles are often needed to implement an evidence-based practice that improves care. This study explored the process of change used to implement clinical guidelines for primary and secondary prevention of cardiovascular disease in primary care practices that used a common electronic medical record (EMR).
Methods
Multiple conceptual frameworks informed the design of this study designed to explain the complex phenomena of implementing change in primary care practice. Qualitative methods were used to examine the processes of change that practice members used to implement the guidelines. Purposive sampling in eight primary care practices within the Practice Partner Research Network-Translating Researching into Practice (PPRNet-TRIP II) clinical trial yielded 28 staff members and clinicians who were interviewed regarding how change in practice occurred while implementing clinical guidelines for primary and secondary prevention of cardiovascular disease and strokes.
Results
A conceptual framework for implementing clinical guidelines into primary care practice was developed through this research. Seven concepts and their relationships were modelled within this framework: leaders setting a vision with clear goals for staff to embrace; involving the team to enable the goals and vision for the practice to be achieved; enhancing communication systems to reinforce goals for patient care; developing the team to enable the staff to contribute toward practice improvement; taking small steps, encouraging practices' tests of small changes in practice; assimilating the electronic medical record to maximize clinical effectiveness, enhancing practices' use of the electronic tool they have invested in for patient care improvement; and providing feedback within a culture of improvement, leading to an iterative cycle of goal setting by leaders.
Conclusion
This conceptual framework provides a mental model which can serve as a guide for practice leaders implementing clinical guidelines in primary care practice using electronic medical records. Using the concepts as implementation and evaluation criteria, program developers and teams can stimulate improvements in their practice settings. Investing in collaborative team development of clinicians and staff may enable the practice environment to be more adaptive to change and improvement.
doi:10.1186/1748-5908-3-3
PMCID: PMC2254645  PMID: 18199330
5.  Using a summary measure for multiple quality indicators in primary care: the Summary QUality InDex (SQUID) 
Background
Assessing the quality of primary care is becoming a priority in national healthcare agendas. Audit and feedback on healthcare quality performance indicators can help improve the quality of care provided. In some instances, fewer numbers of more comprehensive indicators may be preferable. This paper describes the use of the Summary Quality Index (SQUID) in tracking quality of care among patients and primary care practices that use an electronic medical record (EMR). All practices are part of the Practice Partner Research Network, representing over 100 ambulatory care practices throughout the United States.
Methods
The SQUID is comprised of 36 process and outcome measures, all of which are obtained from the EMR. This paper describes algorithms for the SQUID calculations, various statistical properties, and use of the SQUID within the context of a multi-practice quality improvement (QI) project.
Results
At any given time point, the patient-level SQUID reflects the proportion of recommended care received, while the practice-level SQUID reflects the average proportion of recommended care received by that practice's patients. Using quarterly reports, practice- and patient-level SQUIDs are provided routinely to practices within the network. The SQUID is responsive, exhibiting highly significant (p < 0.0001) increases during a major QI initiative, and its internal consistency is excellent (Cronbach's alpha = 0.93). Feedback from physicians has been extremely positive, providing a high degree of face validity.
Conclusion
The SQUID algorithm is feasible and straightforward, and provides a useful QI tool. Its statistical properties and clear interpretation make it appealing to providers, health plans, and researchers.
doi:10.1186/1748-5908-2-11
PMCID: PMC1852570  PMID: 17407560
6.  The effect of ethnicity on outcomes in a practice-based trial to improve cardiovascular disease prevention 
Background
Health disparities are a growing concern. Recently, we conducted a practice-based trial to help primary care physicians improve adherence with 21 quality indicators relevant to the primary and secondary prevention of cardiovascular disease and stroke. Although the primary concern in that study was whether patients in intervention practices outperformed those in control practices, we were also interested in determining whether minority patients were more, less, or just as likely to benefit from the intervention as non-minorities.
Methods
Baseline (fourth quarter 2000) and follow-up (fourth quarter 2002) data were obtained from 3 intervention practices believed to have at least 10% minority representation. Two practices had a black (non-Hispanic) population sufficient for analysis, while the other had a sufficient Hispanic population. Within each practice, changes in the 21 indicators were compared between the minority patient population and the entire patient population. The proportion of measures in which minority patients exhibited greater improvement was calculated for each practice and for all 3 practices combined, and comparisons were made using non-parametric methods.
Results
For all black patients, the observed improvement in 50% of 22 eligible study indicators was better than that observed among all white patients in the same practices. The average changes in the study indicators observed among the black and white patients were not significantly different (p = 0.300) from one another. Likewise for all minority patients in all 3 practices combined, the observed improvement in 14 of 29 (43.3%) eligible study indicators was better than that observed among all white patients. The average changes in the study indicators among all minority patients were not significantly different from the changes observed among the white patients (p = 0.272).
Conclusions
Among 3 intervention practices involved in a quality improvement project, there did not appear to be any significant disparity between minority and non-minority patients in the improvement in study indicators.
doi:10.1186/1475-9276-3-12
PMCID: PMC544361  PMID: 15585057
7.  Colorectal Cancer Screening in Primary Care: Theoretical Model to Improve Prevalance in the Practice Partner Research Network 
Health promotion practice  2009;12(2):229-234.
Colorectal cancer (CRC) is the second leading cause of cancer death in the United States (US). Half of Americans above age 50 are not current with recommended screening; research is needed to assess the impact of interventions designed to increase receipt of CRC screening. The Colorectal Cancer Screening in Primary Care (C-TRIP) study is a theoretically-informed group randomized trial within 32 primary care practices. Baseline median proportion of active patients aged 50 years or older up-to-date with CRC screening among the 32 practices was 50.8% (N=55,746). Men were more likely to be screened than women (52.9% vs. 49.2% respectively). Patients 50–59 years of age were less likely to be up-to-date with screening (45.4%) than those in the 60–69 year and 70–79 years groups (58.5% in both groups). Opportunities exist to increase the proportion of CRC screening received in adults age 50 and older. C-TRIP evaluates the effectiveness of a model for improvement for increasing this proportion.
doi:10.1177/1524839909332139
PMCID: PMC2889237  PMID: 19297657

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