Diabetes Mellitus, Cardiovascular Disease
Conditions
Keywords
implementation strategies, diabetes mellitus, cardiovascular disease, community health centers, quality improvement, translational medical 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?
Interventions
OTHERLow 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
OTHERMedium 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.
OTHERHigh 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.
OTHERComparison
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.
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
OCHIN, Inc.
Kaiser Permanente
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
Clinics were randomized and data was collected at the clinic level, there was no data collected at the participant level.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate Ratio of the Percent of the Clinics' Patients Indicated for Statin With a Guideline-appropriate Prescription for Statins | Monthly, up to 48 months | 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. |
| Rate Ratio of the Percent of the Clinics' Patients Indicated for ACE/ARB With Guideline-appropriate Prescription for ACE/ARBs | Monthly, up to 48 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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). | 3 years post-implementation | Describe the characteristics of clinics that achieve sustained change and of those that do not achieve change |
| Rate Ratio of the Change in the Percent of the Clinic's 'Indicated' Patients With Correct Intensity Statin Prescribing | Monthly, up to 48 months | 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. |
Countries
United States
Participant flow
Recruitment details
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 patients were recruited or consented.
Pre-assignment details
Data was collected at the clinic level, there was no data collected at the participant level and therefore there are no participant numbers available for any results modules.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 3,849 |
| 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 | 9 |
| 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. | 5,098 |
| 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. | 11 |
| 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. | 3,370 |
| 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. | 9 |
| 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. | 33,638 |
| 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. | 137 |
| Total | 46,121 |
Baseline characteristics
| Characteristic | Low Support | Medium Support | High Support | Comparison | Total |
|---|---|---|---|---|---|
| Age, Customized 18-21 years | 31 Participants | 33 Participants | 24 Participants | 212 Participants | 300 Participants |
| Age, Customized 22-39 years | 357 Participants | 574 Participants | 337 Participants | 3649 Participants | 4917 Participants |
| Age, Customized 40-75 years | 3169 Participants | 4064 Participants | 2744 Participants | 27309 Participants | 37286 Participants |
| Age, Customized >75 years | 292 Participants | 427 Participants | 265 Participants | 2468 Participants | 3452 Participants |
| Race/Ethnicity, Customized Race/ethnicity Hispanic | 1249 Participants | 2494 Participants | 652 Participants | 8734 Participants | 13129 Participants |
| Race/Ethnicity, Customized Race/ethnicity Non-Hispanic Black | 44 Participants | 1364 Participants | 196 Participants | 7056 Participants | 8660 Participants |
| Race/Ethnicity, Customized Race/ethnicity Non-Hispanic Other | 127 Participants | 350 Participants | 126 Participants | 2134 Participants | 2737 Participants |
| Race/Ethnicity, Customized Race/ethnicity Non-Hispanic white | 2417 Participants | 880 Participants | 2389 Participants | 15582 Participants | 21268 Participants |
| Race/Ethnicity, Customized Race/ethnicity Unknown | 12 Participants | 10 Participants | 7 Participants | 132 Participants | 161 Participants |
| Sex: Female, Male Female | 2047 Participants | 3057 Participants | 1831 Participants | 18707 Participants | 25642 Participants |
| Sex: Female, Male Male | 1802 Participants | 2041 Participants | 1539 Participants | 14931 Participants | 20313 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
Primary
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.
Time frame: Monthly, up to 48 months
Population: The number of participants is not available for this study, only clinic-level data was collected.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Low Support | Rate Ratio of the Percent of the Clinics' Patients Indicated for ACE/ARB With Guideline-appropriate Prescription for ACE/ARBs | 0.95 Rate ratio |
| Medium Support | Rate Ratio of the Percent of the Clinics' Patients Indicated for ACE/ARB With Guideline-appropriate Prescription for ACE/ARBs | 0.99 Rate ratio |
| High Support | Rate Ratio of the Percent of the Clinics' Patients Indicated for ACE/ARB With Guideline-appropriate Prescription for ACE/ARBs | 0.99 Rate ratio |
| Comparison | Rate Ratio of the Percent of the Clinics' Patients Indicated for ACE/ARB With Guideline-appropriate Prescription for ACE/ARBs | 0.95 Rate ratio |
Primary
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.
Time frame: Monthly, up to 48 months
Population: The number of participants is not available for this study, only clinic-level data was collected.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Low Support | Rate Ratio of the Percent of the Clinics' Patients Indicated for Statin With a Guideline-appropriate Prescription for Statins | 1.09 Rate ratio |
| Medium Support | Rate Ratio of the Percent of the Clinics' Patients Indicated for Statin With a Guideline-appropriate Prescription for Statins | 1.11 Rate ratio |
| High Support | Rate Ratio of the Percent of the Clinics' Patients Indicated for Statin With a Guideline-appropriate Prescription for Statins | 1.06 Rate ratio |
| Comparison | Rate Ratio of the Percent of the Clinics' Patients Indicated for Statin With a Guideline-appropriate Prescription for Statins | 1.04 Rate ratio |
Secondary
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
Time frame: 3 years post-implementation
Secondary
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.
Time frame: Monthly, up to 48 months
Population: The number of participants is not available for this study, only clinic-level data was collected.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Low Support | Rate Ratio of the Change in the Percent of the Clinic's 'Indicated' Patients With Correct Intensity Statin Prescribing | 1.24 Rate ratio |
| Medium Support | Rate Ratio of the Change in the Percent of the Clinic's 'Indicated' Patients With Correct Intensity Statin Prescribing | 1.35 Rate ratio |
| High Support | Rate Ratio of the Change in the Percent of the Clinic's 'Indicated' Patients With Correct Intensity Statin Prescribing | 1.11 Rate ratio |
| Comparison | Rate Ratio of the Change in the Percent of the Clinic's 'Indicated' Patients With Correct Intensity Statin Prescribing | 1.17 Rate ratio |