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

Kaiser Permanente

Status: Completed

Conditions: Diabetes Mellitus; Cardiovascular Disease

Treatments: Other: Low support; Other: High support; Other: Medium support; Other: Comparison

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02325531

1R01HL120894-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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?

Enrollment: 166 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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166 participants in 4 patient groups

Low support

Other group

Description:

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

Treatment:

Other: Low support

Medium support

Other group

Description:

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

Treatment:

Other: Medium support

High support

Other group

Description:

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

Treatment:

Other: High support

Comparison

Other group

Description:

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.

Treatment:

Other: Comparison