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Trial record 1 of 1 for:    NCT02325531
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SPREAD-NET: PRactices Enabling Adapting and Disseminating in the Safety NET (SPREAD-NET)

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ClinicalTrials.gov Identifier: NCT02325531
Recruitment Status : Active, not recruiting
First Posted : December 25, 2014
Last Update Posted : September 2, 2020
Sponsor:
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
Ochin, Inc.
Information provided by (Responsible Party):
Kaiser Permanente

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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Cardiovascular Disease Other: ALL Not Applicable

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?

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20000 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: SPREAD-NET: PRactices Enabling Adapting and Disseminating in the Safety NET
Study Start Date : September 2014
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : May 2021

Arm Intervention/treatment
Low support

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

Other: 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.


Medium support

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.

Other: 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.


High support

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.

Other: 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 Outcome Measures :
  1. 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 ]
    % clinic's 'indicated' patients with: (a) last systolic BP <135, last diastolic BP <80, (b) last LDL <100


Secondary Outcome Measures :
  1. 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 ]
    Effectiveness: Rate of patient BP, LDL 'under control' (targeted by statins, ACE/ARBs, respectively)

  2. 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 ]
    Adoption: Use of toolkit elements such as site participation / uptake rates and staff participation / uptake rates overall and by staff role (MD, RN, MA, etc.)

  3. Changes to staff training materials, patient education materials, patient panel management rosters, other reminder tools [ Time Frame: Monthly, up to 48 months ]
    Implementation: Compliance with, fidelity / adaptation to toolkit elements across and within sites

  4. 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 ]
    Maintenance: Toolkit elements adapted, retained, integrated into workflow, and primary, secondary outcome effects, over time



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02325531


Locations
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United States, Oregon
Kaiser Permanente - Center for Health Research
Portland, Oregon, United States, 97227
Sponsors and Collaborators
Kaiser Permanente
National Heart, Lung, and Blood Institute (NHLBI)
Ochin, Inc.
Investigators
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Principal Investigator: Rachel Gold, PhD, MPH Kaiser Permanente
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Kaiser Permanente
ClinicalTrials.gov Identifier: NCT02325531    
Other Study ID Numbers: 1R01HL120894-01 ( U.S. NIH Grant/Contract )
1R01HL120894-01 ( U.S. NIH Grant/Contract )
First Posted: December 25, 2014    Key Record Dates
Last Update Posted: September 2, 2020
Last Verified: August 2020
Keywords provided by Kaiser Permanente:
implementation strategies
diabetes mellitus
cardiovascular disease
community health centers
quality improvement
translational medical research
Additional relevant MeSH terms:
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Cardiovascular Diseases
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases