SPREAD-NET: PRactices Enabling Adapting and Disseminating in the Safety NET
Condition: Diabetes Mellitus; Cardiovascular Disease
MeSH terms: Cardiovascular Diseases; Diabetes Mellitus
Study type: Interventional

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.
    

Detailed 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?
    

Intervention name(s): Low support; Medium support; High support; Comparison
Intervention type(s): Other; Other; Other; Other
Intervention description(s): EHR-based tools, built by OCHIN, activated during Year 1 TOOLKIT, paper and electronic form, includes documents to help support ALL implementation, and
BASIC WEBINAR, Annual, 1-hour, topics such as:
Talking to Clinicians About ALL, Using The Monthly Feedback Report and Integrating the Toolkit into Workflows; Same as provided to the low support arm, PLUS
STAFF TRAINING (2-day meeting in Portland, Oregon, Led by Implementation Specialists (IS), How to use the toolkit and how to train others to use it, Content guided by previous research, baseline survey results, study team and the S-N advisory group
ADAPTIVE WEBINARS, Quarterly 1-hr webinars, Content from basic webinars, tailored to topics requested by study clinics. Forum for group discussion and best practice sharing. Open any interested clinics in Arm 2 & 3.; Same as provided to the low and medium support arms, PLUS
- PRACTICE FACILITATION: Site visits with support as needed, Staff presentations, Coaching on tools (how to present to clinic staff and how to use in the clinic workflow), Tailored problem-solving support to address identified barriers, Clinical questions fielded by RN practice facilitator and site clinician champion.; No support was provided by the researchers. The EHR-based toolkit was available to all clinics in the network if they actively searched it out in the EHR.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Clinics were randomized and data was collected at the clinic level, there was no data collected at the participant level.
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: implementation strategies; diabetes mellitus; cardiovascular disease; community health centers; quality improvement; translational medical research