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

Study Overview
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Brief Summary
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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
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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?

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

Conditions
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Diabetes Mellitus, Cardiovascular Disease

Intervention / Treatment
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* Other: Low support
* Other: Medium support
* Other: High support
* Other: Comparison


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Convenience sample, all patients with Diabetes Mellitus from 30 community health clinics (CHCs) that are members of OCHIN, Inc. Exclusion Criteria: Patients without diagnosed DM

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Low support<br>In this pragmatic comparative effectiveness trial, clinics NOT patients were randomized. Clinics were randomly assigned to one of the arms and support was provided to the clinic, not the patient. EHR-based toolkit Basic webinar | Other: Low support<br>* 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<br>|
| Other: Medium support<br>In this pragmatic comparative effectiveness trial, clinics NOT patients were randomized. Clinics were randomly assigned to one of the arms and support was provided to the clinic, not the patient. Support provided to the low support arm, PLUS Staff training Adaptive webinars | Other: Medium support<br>* 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.<br>|
| Other: High support<br>In this pragmatic comparative effectiveness trial, clinics NOT patients were randomized. Clinics were randomly assigned to one of the arms and support was provided to the clinic, not the patient. Support provided to the low and medium support arms, PLUS Practice facilitation | Other: High support<br>* 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.<br>|
| Other: Comparison<br>In this pragmatic comparative effectiveness trial, clinics NOT patients were randomized. Clinics were randomly assigned to one of the arms and support was provided to the clinic, not the patient. 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. | Other: Comparison<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate Ratio of the Percent of the Clinics' Patients Indicated for Statin With a Guideline-appropriate Prescription for Statins | The data reported in the outcome measure data table is the rate ratio of the change in the percent of the clinic's 'indicated' patients with guideline-appropriate prescription for statins. Each monthly denominator included the patients who had an in-clinic encounter in the last year and were indicated for the medication per national guidelines that month. Therefore, the number of participants and who those participants were varied at each time of measurement. From month to month the set of participants could be completely different. The percent of patients indicated for a statin with an active prescription by month can be found in Figure 2 of the publication linked in this record: Gold, 2019. This is the only data available. | Monthly, up to 48 months | 
| Rate Ratio of the Percent of the Clinics' Patients Indicated for ACE/ARB With Guideline-appropriate Prescription for ACE/ARBs | The data reported in the outcome measure data table is the rate ratio of the change in the percent of the clinic's 'indicated' patients with guideline-appropriate prescription for ACE/ARBs. Each monthly denominator included the patients who had an in-clinic encounter in the last year and were indicated for the medication per national guidelines that month. Therefore, the number of participants and who those participants were varied at each time of measurement. From month to month the set of participants could be completely different. The percent of patients indicated for an ACE/ARB with an active prescription by month can be found in Figure 3 of the publication linked in this record: Gold, 2019. This is the only data available. | Monthly, up to 48 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identify Clinic Characteristics Associated With the Support Strategies' Effectiveness (e.g. Decision-making Structures, Leadership Support, Team Processes I Characteristics, Readiness and Capacity for Change). | Describe the characteristics of clinics that achieve sustained change and of those that do not achieve change | 3 years post-implementation | 
| Rate Ratio of the Change in the Percent of the Clinic's 'Indicated' Patients With Correct Intensity Statin Prescribing | The data reported in the outcome measure data table is the rate ratio of the change in the percent of the clinic's 'indicated' patients with correct intensity statin prescribing. Each monthly denominator included the patients who had an in-clinic encounter in the last year and were indicated for the medication per national guidelines that month. Therefore, the number of participants and who those participants were varied at each time of measurement. From month to month the set of participants could be completely different. The percent of patients with correct intensity statin prescribing by month can be found in Figure 2 of the publication linked in this record: Gold, 2019. This is the only data available. | Monthly, up to 48 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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implementation strategies, diabetes mellitus, cardiovascular disease, community health centers, quality improvement, translational medical research