Clinical trial NCT02325531: SPREAD-NET: PRactices Enabling Adapting and Disseminating in the Safety NET
Official title: SPREAD-NET: PRactices Enabling Adapting and Disseminating in the Safety NET
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Cardiovascular Disease
Keywords: implementation strategies
diabetes mellitus
cardiovascular disease
community health centers
quality improvement
translational medical research
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
name: OCHIN, Inc.
First posted: 2014-12-25
Enrollment: 166
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Clinics were randomized and data was collected at the clinic level, there was no data collected at the participant level.
Primary purpose: HEALTH_SERVICES_RESEARCH

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?

Eligibility criteria: 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

Primary outcomes:
measure: Rate Ratio of the Percent of the Clinics' Patients "Indicated" for Statin With a Guideline-appropriate Prescription for Statins
timeFrame: Monthly, up to 48 months
measure: Rate Ratio of the Percent of the Clinics' Patients "Indicated" for ACE/ARB With Guideline-appropriate Prescription for ACE/ARBs
timeFrame: Monthly, up to 48 months
Secondary outcomes:
measure: 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).
timeFrame: 3 years post-implementation
measure: Rate Ratio of the Change in the Percent of the Clinic's 'Indicated' Patients With Correct Intensity Statin Prescribing
timeFrame: Monthly, up to 48 months
Other outcomes:
Locations:
city: Portland
country: United States
facility: Kaiser Permanente - Center for Health Research
state: Oregon
Study officials:
affiliation: Kaiser Permanente
name: Rachel Gold, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.