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

Not Applicable

Completed

Conditions: Diabetes Mellitus
Cardiovascular Disease

Interventions: Other: High support
Other: Low support
Other: Medium support
Other: Comparison

Registration Number: NCT02325531

Lead Sponsor: Kaiser Permanente

Brief 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?

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 166

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High support	High support	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
Low support	Low support	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
Medium support	Medium support	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
Comparison	Comparison	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.

Primary Outcome Measures

Name	Time	Method
Rate Ratio of the Percent of the Clinics' Patients "Indicated" for ACE/ARB With Guideline-appropriate Prescription for ACE/ARBs	Monthly, up to 48 months	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.
Rate Ratio of the Percent of the Clinics' Patients "Indicated" for Statin With a Guideline-appropriate Prescription for Statins	Monthly, up to 48 months	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.

Secondary Outcome Measures

Name	Time	Method
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).	3 years post-implementation	Describe the characteristics of clinics that achieve sustained change and of those that do not achieve change
Rate Ratio of the Change in the Percent of the Clinic's 'Indicated' Patients With Correct Intensity Statin Prescribing	Monthly, up to 48 months	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.

Trial Locations

Locations (1): Kaiser Permanente - Center for Health Research
🇺🇸
Portland, Oregon, United States
Kaiser Permanente - Center for Health Research
🇺🇸Portland, Oregon, United States