SPREAD-NET: PRactices Enabling Adapting & Disseminating in the Safety NET

Status Completed

Clinical Trial Summary

The investigators propose to compare the effectiveness of 3 strategies (low, medium, high intensity) at supporting CHCs' implementation of the ALL Initiative (an intervention shown to reduce patients' cardiovascular disease (CVD) event risk), through a cluster-randomized trial.

Clinical Trial Description

The investigators propose to compare the effectiveness of 3 support strategies for optimizing the sustainable implementation of the evidence-based ALL intervention. To do so, the investigators will randomize 30 community health centers (CHCs) to receive 1 of 3 implementation support strategies: Low support (toolkit only), Medium (toolkit, staff training), High (toolkit, training, on-site facilitation). The study aims are as follows: Aim 1: Compare the effectiveness of the 3 strategies (low, medium, high intensity) at supporting CHCs' implementation of the ALL intervention, through a cluster-randomized trial. Hypothesis: Clinics randomized to receive more implementation support will be more likely than those randomized to receive less support (high>medium>low) to significantly improve the percent of their patients with (i) guideline-appropriate prescriptions for ACE/ARBs and statins, and (ii) last blood pressure (BP) and low-density lipoprotein (LDL) under control). Aim 2: Assess how effectively the 3 strategies support intervention sustainability at 12, 24 and 36 months post-implementation, measured as maintenance of change over time (outcomes as in Aim 1). Hypothesis: Clinics randomized to receive more implementation support will be more likely to maintain changes in the outcomes of interest. Aim 3: Identify clinic characteristics associated with the support strategies' effectiveness (e.g. decision-making structures, leadership support, team processes / characteristics, readiness and capacity for change). Research questions: What are the characteristics of clinics that achieve sustained change even with less implementation support, and of those that do not achieve change even with more support? ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02325531
Study type	Interventional
Source	Kaiser Permanente
Contact
Status	Completed
Phase	N/A
Start date	September 2014
Completion date	August 2021

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

SPREAD-NET: PRactices Enabling Adapting and Disseminating in the Safety NET — SPREAD-NET

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms