Overview

This trial is active, not recruiting.

Conditions diabetes mellitus, cardiovascular disease
Treatment all
Sponsor Kaiser Permanente
Collaborator National Heart, Lung, and Blood Institute (NHLBI)
Start date September 2014
End date May 2018
Trial size 20000 participants
Trial identifier NCT02325531, 1R01HL120894-01

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model factorial assignment
Masking open label
Primary purpose health services research
Arm
(Other)
Low support (toolkit only), includes the following: 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
all
The ALL Initiative ('ALL') is a population-level management program developed at Kaiser Permanente (KP). It seeks to decrease cardiovascular disease (CVD) morbidity and mortality in patients with diabetes by improving rates of prescribing for guideline-concordant cardioprotective medications. For SPREAD-NET, we propose to compare the effectiveness of 3 support strategies for optimizing the sustainable implementation of the evidence-based ALL intervention. To do so, we will randomize 30 CHCs to receive 1 of 3 implementation support strategies: Low support (toolkit only), Medium (toolkit, staff training), High (toolkit, training, on-site facilitation). Using a mixed methods approach, we will assess how effectively each strategy supports sustainable implementation of ALL at the practice- and patient-levels, and we will identify clinic characteristics associated with success at each level of support. We will also conduct a cost analysis to compare costs per patient in each study arm.
(Other)
Medium support (toolkit, staff training), includes the following: Same as above (EHR-based tools, built by OCHIN, activated during Year 1 TOOLKIT, paper and electronic form, includes documents to help support ALL implementation) 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 Plus 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.
all
The ALL Initiative ('ALL') is a population-level management program developed at Kaiser Permanente (KP). It seeks to decrease cardiovascular disease (CVD) morbidity and mortality in patients with diabetes by improving rates of prescribing for guideline-concordant cardioprotective medications. For SPREAD-NET, we propose to compare the effectiveness of 3 support strategies for optimizing the sustainable implementation of the evidence-based ALL intervention. To do so, we will randomize 30 CHCs to receive 1 of 3 implementation support strategies: Low support (toolkit only), Medium (toolkit, staff training), High (toolkit, training, on-site facilitation). Using a mixed methods approach, we will assess how effectively each strategy supports sustainable implementation of ALL at the practice- and patient-levels, and we will identify clinic characteristics associated with success at each level of support. We will also conduct a cost analysis to compare costs per patient in each study arm.
(Other)
High support (toolkit, training, on-site facilitation), includes the following: Same as above (EHR-based tools, built by OCHIN, activated during Year 1 TOOLKIT, paper and electronic form, includes documents to help support ALL implementation, STAFF TRAINING, and ADAPTIVE WEBINARS 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.
all
The ALL Initiative ('ALL') is a population-level management program developed at Kaiser Permanente (KP). It seeks to decrease cardiovascular disease (CVD) morbidity and mortality in patients with diabetes by improving rates of prescribing for guideline-concordant cardioprotective medications. For SPREAD-NET, we propose to compare the effectiveness of 3 support strategies for optimizing the sustainable implementation of the evidence-based ALL intervention. To do so, we will randomize 30 CHCs to receive 1 of 3 implementation support strategies: Low support (toolkit only), Medium (toolkit, staff training), High (toolkit, training, on-site facilitation). Using a mixed methods approach, we will assess how effectively each strategy supports sustainable implementation of ALL at the practice- and patient-levels, and we will identify clinic characteristics associated with success at each level of support. We will also conduct a cost analysis to compare costs per patient in each study arm.

Primary Outcomes

Measure
Number of patients indicated for ACE/ARB and statin who had an active prescription for both, as a proportion of patients indicated for ACE/ARB and statin.
time frame: Monthly, up to 48 months

Secondary Outcomes

Measure
Percentage of clinic's 'indicated' patients with: (a) last systolic BP <135, last diastolic BP <80, (b) last LDL <100
time frame: Monthly, up to 48 months
Percentage of: indicated patients receiving outreach calls, indicated patient encounters where: (i) appropriate prescription given, (ii) prescription 'order set' used, (iii) patient education materials used, etc. and staff attending relevant trainings
time frame: Monthly, up to 48 months
Changes to staff training materials, patient education materials, patient panel management rosters, other reminder tools
time frame: Monthly, up to 48 months
Previous measures at 2 and 3 years post-implementation (Maintenance: Toolkit elements adapted, retained, integrated into workflow, and primary, secondary outcome effects, over time)
time frame: 2 and 3 years post-implementation, up to 24 and 36 months

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

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

Additional Information

Official title SPREAD-NET: PRactices Enabling Adapting and Disseminating in the Safety NET
Principal investigator Rachel Gold, PhD, MPH
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?
Trial information was received from ClinicalTrials.gov and was last updated in September 2015.
Information provided to ClinicalTrials.gov by Kaiser Permanente.