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

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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Disease; Diabetes Mellitus
• Intervention / Treatment: Other: Low support; Other: Medium support; Other: High support; Other: Comparison

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?

• Study Type: Interventional
• Enrollment (Actual): 166
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Portland, Oregon, United States, 97227
      • Kaiser Permanente - Center for Health Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 71 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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	Other: Low support; 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
Other: 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	Other: Medium support; 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.
Other: 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	Other: High support; 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.
Other: 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.	Other: Comparison; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Kaiser Permanente
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI); OCHIN, Inc.
• Investigators: Principal Investigator: Rachel Gold, PhD, MPH, Kaiser Permanente

Publications and helpful links

General Publications

• Gold R, Bunce A, Cowburn S, Davis JV, Nelson JC, Nelson CA, Hicks E, Cohen DJ, Horberg MA, Melgar G, Dearing JW, Seabrook J, Mossman N, Bulkley J. Does increased implementation support improve community clinics' guideline-concordant care? Results of a mixed methods, pragmatic comparative effectiveness trial. Implement Sci. 2019 Dec 5;14(1):100. doi: 10.1186/s13012-019-0948-5.
• Gruss I, Bunce A, Davis J, Gold R. Unintended consequences: a qualitative study exploring the impact of collecting implementation process data with phone interviews on implementation activities. Implement Sci Commun. 2020 Nov 4;1(1):101. doi: 10.1186/s43058-020-00093-7.
• Bunce AE, Gruss I, Davis JV, Cowburn S, Cohen D, Oakley J, Gold R. Lessons learned about the effective operationalization of champions as an implementation strategy: results from a qualitative process evaluation of a pragmatic trial. Implement Sci. 2020 Oct 1;15(1):87. doi: 10.1186/s13012-020-01048-1.
• Gold R, Hollombe C, Bunce A, Nelson C, Davis JV, Cowburn S, Perrin N, DeVoe J, Mossman N, Boles B, Horberg M, Dearing JW, Jaworski V, Cohen D, Smith D. Study protocol for "Study of Practices Enabling Implementation and Adaptation in the Safety Net (SPREAD-NET)": a pragmatic trial comparing implementation strategies. Implement Sci. 2015 Oct 16;10:144. doi: 10.1186/s13012-015-0333-y.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2014
• Primary Completion (Actual): August 1, 2021
• Study Completion (Actual): August 1, 2021

Study Registration Dates

• First Submitted: December 15, 2014
• First Submitted That Met QC Criteria: December 24, 2014
• First Posted (Estimate): December 25, 2014

Study Record Updates

• Last Update Posted (Estimate): December 13, 2022
• Last Update Submitted That Met QC Criteria: November 15, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: cardiovascular disease; diabetes mellitus; quality improvement; translational medical research; community health centers; implementation strategies
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Cardiovascular Diseases; Diabetes Mellitus
• Other Study ID Numbers: 1R01HL120894-01 (U.S. NIH Grant/Contract)