SPREAD-NET: PRactices Enabling Adapting and Disseminating in the Safety NET
NCT ID: NCT02325531
Last Updated: 2022-12-13
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
NA
166 participants
INTERVENTIONAL
2014-09-30
2021-08-31
Brief Summary
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Detailed Description
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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?
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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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
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
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
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.
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
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.
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.
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.
Interventions
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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
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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
75 Years
ALL
Yes
Sponsors
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National Heart, Lung, and Blood Institute (NHLBI)
NIH
OCHIN, Inc.
OTHER
Kaiser Permanente
OTHER
Responsible Party
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Principal Investigators
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Rachel Gold, PhD, MPH
Role: PRINCIPAL_INVESTIGATOR
Kaiser Permanente
Locations
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Kaiser Permanente - Center for Health Research
Portland, Oregon, United States
Countries
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References
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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.
Provided Documents
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