Dataset Information

Advancing heart health in North Carolina primary care: the Heart Health NOW study protocol.

ABSTRACT: The objective of Heart Health NOW (HHN) is to determine if primary care practice support-a comprehensive evidence-based quality improvement strategy involving practice facilitation, academic detailing, technology support, and regional learning collaboratives-accelerates widespread dissemination and implementation of evidence-based guidelines for cardiovascular disease (CVD) prevention in small- to medium-sized primary care practices and, additionally, increases practices' capacity to incorporate other evidence-based clinical guidelines in the future.HHN is a stepped wedge, stratified, cluster randomized trial to evaluate the effect of primary care practice support on evidence-based CVD prevention, organizational change process measures, and patient outcomes. Each practice will start the trial as a control, receive the intervention at a randomized time point, and then enter a maintenance period 12 months after the start of the intervention. The intervention will be randomized to practices in one of four strata defined by region of the state (east or west) and degree of practice readiness for change. Seventy-five practices in each region with a high degree of readiness will be randomized 1:1:1 in blocks of 3 sometime prior to month 8 to receive the intervention at month 9, 11, or 12. An additional 75 practices within each region that have a low degree of readiness or are recruited later will be randomized 1:1 in blocks of 2 prior to month 13 to receive the intervention at month 14 or 16. The sites will be ordered within each strata based on time of enrollment with the blocking based on this ordering. Evaluation will examine the effect of primary care practice support on (1) practice-level delivery of evidence-based CVD prevention, (2) patient-level health outcomes, (3) practice-level implementation of clinical and organizational changes that support delivery of evidence-based CVD prevention, and (4) practice-level capacity to implement future evidence-based clinical guidelines.Results will indicate whether primary care practice support is an effective strategy for widespread dissemination and implementation of evidence-based clinical guidelines in primary care practices. Discernible reductions in cardiovascular risk in 300 practices covering over an estimated 900,000 adult patients would likely lead to prevention of thousands of cardiovascular events within 10 years.ClinicalTrials.gov NCT02585557.

SUBMITTER: Weiner BJ

PROVIDER: S-EPMC4650518 | biostudies-literature | 2015 Nov

REPOSITORIES: biostudies-literature

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Advancing heart health in North Carolina primary care: the Heart Health NOW study protocol.

Weiner Bryan J BJ Pignone Michael P MP DuBard C Annette CA Lefebvre Ann A Suttie Janet L JL Freburger Janet K JK Cykert Samuel S

Implementation science : IS 20151114

<h4>Background</h4>The objective of Heart Health NOW (HHN) is to determine if primary care practice support-a comprehensive evidence-based quality improvement strategy involving practice facilitation, academic detailing, technology support, and regional learning collaboratives-accelerates widespread dissemination and implementation of evidence-based guidelines for cardiovascular disease (CVD) prevention in small- to medium-sized primary care practices and, additionally, increases practices' capa ...[more]

PMID: 26577091

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Project description:BACKGROUND:Participation in clinical trials among people of color remains low, compared with white subjects. This protocol describes the development of "Advancing People of Color in Clinical Trials Now!" (ACT Now!), a culturally tailored website designed to influence clinical trial decision making among people of color. OBJECTIVE:This cluster randomized study aims to test the efficacy of a culturally tailored website to increase literacy, self-efficacy, and willingness to enroll in clinical trials among people of color. METHODS:ACT Now! is a randomized trial including 2 groups: (1) intervention group (n=50) with access to the culturally tailored website and (2) control group (n=50) exposed to a standard clinical recruitment website. Clinical trial literacy and willingness to enroll in a clinical trial will be measured before and after exposure to the website corresponding to their assigned group (intervention or control). Surveys will be conducted at baseline and during the 1-month postintervention and 3-month follow-up. Website architecture and wireframing will be informed by the literature and experts in the field. Statistical analysis will be conducted using a two-tailed t test, with 80% power, at .05 alpha level, to increase clinical trial literacy, self-efficacy, and willingness to enroll in clinical trials 3 months post intervention. RESULTS:We will design a culturally tailored website that will provide leverage for community stakeholders to influence clinical trial literacy, self-efficacy, and willingness to enroll in clinical trials among racial and ethnic groups. ACT Now! applies a community-based participatory research approach through the use of a community steering committee (CSC). The CSC provides input during the research study conception, development, implementation, and enrollment. CSC relationships help foster trust among communities of color. ACT Now! has the potential to fill a gap in clinical trial enrollment among people of color through an accessible web-based website. This study was funded in July 2017 and obtained institutional review board approval in spring 2017. As of December 2019, we had enrolled 100 participants. Data analyses are expected to be completed by June 2020, and expected results are to be published in fall 2020. CONCLUSIONS:ACT Now! has the potential to fill an important gap in clinical trial enrollment among people of color through an accessible web-based website. TRIAL REGISTRATION:ClinicalTrials.gov NCT03243071; https://clinicaltrials.gov/ct2/show/NCT00102401. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):DERR1-10.2196/17589.

Project description:BACKGROUND:Chronic low back disorders (CLBDs) are a substantial burden on individuals and societies, and impact up to 20% of Canadians. Rural and remote residents are approximately 30% more likely to have CLBDs. Reduced access to appropriate team-based health services, including physical therapy, is a key factor that may magnify the impact of CLBD on pain, physical function, overall quality of life, health-related system costs, and individual costs. OBJECTIVE:The purpose of this project is to evaluate the validity, comparative effectiveness, costs, barriers, and facilitators of an interprofessional management approach for people with CLBDs, delivered via telehealth. METHODS:This project will examine 3 different health care delivery options: (1) in-person nurse practitioner (NP); (2) in-person physical therapist (PT); and (3) a team approach utilizing an NP (in-person) and a PT joining via telehealth. Validity of the telehealth team care model will be explored by comparing the diagnostic categorization and management recommendations arising from participants with CLBD who undergo a team telehealth, in-person NP, and in-person PT assessment. Comparative effectiveness and costs will be examined using a community-based randomized controlled trial in a rural Saskatchewan community with limited PT services. The 3 arms of the trial are: (1) usual care delivered by a local rural NP; (2) a local NP and an urban-based PT joining via telehealth; and (3) face-to-face services by a PT traveling to the community. Patient-reported outcomes of pain, physical function, quality of life, satisfaction, and CLBD care-related costs will be evaluated up to 6 months after the intervention. Patient and provider experiences with the team telehealth approach will be explored through qualitative interviews. RESULTS:The study was funded in July 2013 and the University of Saskatchewan Biomedical Research Ethics Board approved the study in November 2013. Participant recruitment began in September 2014 and data collection was completed in December 2015. Analysis is in progress and results are anticipated in 2017. CONCLUSIONS:CLBD is a widespread public health problem, particularly in rural and remote areas, which requires new innovative approaches to deliver appropriate health care. The results of this project will inform the development of evidence-informed approaches and community-based implementation strategies to improve access to PT services in primary health care settings in other rural and remote underserved areas. Findings might also provide a framework for cost-effective and patient-centered models of service delivery for the management of other chronic conditions. CLINICALTRIAL:ClinicalTrials.gov NCT02225535; https://clinicaltrials.gov/ct2/show/NCT02225535 (Archived by WebCite at http://www.webcitation.org/6lqLTCNF7).

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Dataset Information

Advancing heart health in North Carolina primary care: the Heart Health NOW study protocol.

Publications

Advancing heart health in North Carolina primary care: the Heart Health NOW study protocol.

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