Clinical trial NCT02515578: Southwest Health Extension Partnership to Enhance Research Dissemination
Official title: Southwest Health Extension Partnership to Enhance Research Dissemination
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Diseases
Keywords: Primary Health Care
Cardiovascular Diseases
Quality Improvement
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: University of New Mexico
First posted: 2015-08-05
Enrollment: 5508
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Heart disease and strokes cause one in three deaths reported each year in the United States. Primary care practices need to implement new research findings that help decrease patients' risk for heart disease and stroke. This project will help to build primary care practice capacity for quality improvement and change management in small and medium size primary care practices in Colorado and New Mexico. This project will also help practices implement patient-centered outcomes research findings.

Detailed description: Cardiovascular disease (CVD) causes one in three deaths reported each year in the United States. Strategies derived from patient-centered outcomes research (PCOR) that address CVD risk factors can greatly reduce the burden of CVD. Primary care practices must transform to deliver a higher level of PCOR evidence-based prevention to decrease cardiovascular risk. PCOR interventions that emphasize patient-centered care including self-management support, team-based care, improved information systems, and active quality improvement have been shown to be effective. Practices often require assistance integrating new programs into clinical operations. Practice facilitation has been shown to enhance implementation of new programs for patients with chronic disease in primary care. Other methods of practice support, including academic detailing, collaborative learning sessions, and health information technology assistance, have also been shown to be effective, by themselves and in combination with practice facilitation. Patient involvement may also aid practice transformation. Increasingly, practices are actively including patients as part of the change process through the creation of patient advisory councils and including patients in practice quality improvement teams. Another method of patient involvement to inform implementation of evidence-based care is the Boot Camp Translation process, in which patients collaborate with primary care clinicians, staff members, and community members to translate best practices into culturally and community relevant implementation at the local level. However, while these efforts have had considerable success, no study has looked at the incremental value of adding patient engagement strategies to the more standard approaches to practice transformation listed above. This project would implement the Southwest Health Extension Program to Enhance Research Dissemination (SHEPERD) as a cooperative program to build primary care practice capacity for quality improvement, change management, and implementation of PCOR findings in small and medium size primary care practices in Colorado and New Mexico, with an initial focus on cardiovascular care. It also would conduct a cluster randomized trial with an external matched cohort control group to examine the Reach, Effectiveness, Adoption, Implementation, and Maintenance of two approaches to practice transformation to implement PCOR interventions for reducing cardiovascular risks in primary care practices, comparing the impact of 1) a standard practice transformation support intervention (including practice facilitation, practice assessment with feedback, HIT assistance, academic detailing, and collaborative learning sessions) to 2) an approach that adds patient engagement activities (including patient advisory councils and boot camp translation) as part of the practice transformation support. This project will provide critical information regarding the added value of patient engagement in practice transformation efforts and will also result in a network of practices across the region with increased capacity for practice transformation and implementation of PCOR findings.

Eligibility criteria: Inclusion Criteria:

* Must be staff or clinicians (including physicians, nurse practitioners, and physician assistants) in an enrolled primary care practice
* Primary care practices must be family medicine or general internal medicine practices with a maximum of ten lead clinicians
* Primary care practices must be either independent or, if part of a larger organization, demonstrate on careful screening that they do not receive significant quality improvement support from the larger organization

Exclusion Criteria:

* Primary care practices with more than 10 lead clinicians
* Non-independent primary care practices that receive significant quality improvement support from their system or organization
* Clinicians and staff who do not speak or read English

Primary outcomes:
measure: Change of documentation of aspirin therapy in patients with ischemic vascular disease.
timeFrame: Baseline, 3, 6, 9, 12, and 15 months from baseline
measure: Change of documentation of blood pressure in patients with a diagnosis of hypertension.
timeFrame: Baseline, 3, 6, 9, 12, and 15 months from baseline
measure: Change of documentation of blood pressure in patients with adequately controlled blood pressure.
timeFrame: Baseline, 3, 6, 9, 12, and 15 months from baseline
measure: Change of documentation of fasting LDL in patients with a fasting LDL at or below the LDL goal.
timeFrame: Baseline, 3, 6, 9, 12, and 15 months from baseline
measure: Change of documentation of patients who had a fasting LDL test performed and prescribed a statin based on risk.
timeFrame: Baseline, 3, 6, 9, 12, and 15 months from baseline
measure: Change of documentation of patients screened about tobacco use.
timeFrame: Baseline, 3, 6, 9, 12, and 15 months from baseline
Secondary outcomes:
measure: Change of the documentation in primary care practice's.
timeFrame: Baseline, 9 and 15 months from baseline
Other outcomes:
Locations:
city: Denver
country: United States
facility: University of Colorado, Denver
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: W. Perry Dickinson, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fernald DH, Mullen R, Hall T, Bienstock A, Kirchner S, Knierim K, de la Cerda D, Callan D, Rhyne RL, Dickinson LM, Dickinson WP. Exemplary Practices in Cardiovascular Care: Results on Clinical Quality Measures from the EvidenceNOW Southwest Cooperative. J Gen Intern Med. 2020 Nov;35(11):3197-3204. doi: 10.1007/s11606-020-06094-5. Epub 2020 Aug 17.
citation: English AF, Dickinson LM, Zittleman L, Nease DE Jr, Herrick A, Westfall JM, Simpson MJ, Fernald DH, Rhyne RL, Dickinson WP. A Community Engagement Method to Design Patient Engagement Materials for Cardiovascular Health. Ann Fam Med. 2018 Apr;16(Suppl 1):S58-S64. doi: 10.1370/afm.2173.