Trial Outcomes & Findings for SPREAD-NET: PRactices Enabling Adapting and Disseminating in the Safety NET (NCT NCT02325531)
NCT ID: NCT02325531
Last Updated: 2022-12-13
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
166 participants
Primary outcome timeframe
Monthly, up to 48 months
Results posted on
2022-12-13
Participant Flow
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.
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.
Unit of analysis: Clinics
Participant milestones
| Measure |
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.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
0 9
|
0 11
|
0 9
|
0 137
|
|
Overall Study
COMPLETED
|
0 9
|
0 11
|
0 7
|
0 137
|
|
Overall Study
NOT COMPLETED
|
0 0
|
0 0
|
0 2
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
SPREAD-NET: PRactices Enabling Adapting and Disseminating in the Safety NET
Baseline characteristics by cohort
| Measure |
Low Support
n=9 Clinics
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
n=11 Clinics
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
n=9 Clinics
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
n=137 Clinics
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.
|
Total
n=166 Clinics
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Customized
18-21 years
|
31 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
212 Participants
n=4 Participants
|
300 Participants
n=21 Participants
|
|
Age, Customized
22-39 years
|
357 Participants
n=5 Participants
|
574 Participants
n=7 Participants
|
337 Participants
n=5 Participants
|
3649 Participants
n=4 Participants
|
4917 Participants
n=21 Participants
|
|
Age, Customized
40-75 years
|
3169 Participants
n=5 Participants
|
4064 Participants
n=7 Participants
|
2744 Participants
n=5 Participants
|
27309 Participants
n=4 Participants
|
37286 Participants
n=21 Participants
|
|
Age, Customized
>75 years
|
292 Participants
n=5 Participants
|
427 Participants
n=7 Participants
|
265 Participants
n=5 Participants
|
2468 Participants
n=4 Participants
|
3452 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
2047 Participants
n=5 Participants
|
3057 Participants
n=7 Participants
|
1831 Participants
n=5 Participants
|
18707 Participants
n=4 Participants
|
25642 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
1802 Participants
n=5 Participants
|
2041 Participants
n=7 Participants
|
1539 Participants
n=5 Participants
|
14931 Participants
n=4 Participants
|
20313 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Race/ethnicity · Non-Hispanic white
|
2417 Participants
n=5 Participants
|
880 Participants
n=7 Participants
|
2389 Participants
n=5 Participants
|
15582 Participants
n=4 Participants
|
21268 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Race/ethnicity · Non-Hispanic Black
|
44 Participants
n=5 Participants
|
1364 Participants
n=7 Participants
|
196 Participants
n=5 Participants
|
7056 Participants
n=4 Participants
|
8660 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Race/ethnicity · Non-Hispanic Other
|
127 Participants
n=5 Participants
|
350 Participants
n=7 Participants
|
126 Participants
n=5 Participants
|
2134 Participants
n=4 Participants
|
2737 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Race/ethnicity · Hispanic
|
1249 Participants
n=5 Participants
|
2494 Participants
n=7 Participants
|
652 Participants
n=5 Participants
|
8734 Participants
n=4 Participants
|
13129 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Race/ethnicity · Unknown
|
12 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
132 Participants
n=4 Participants
|
161 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Monthly, up to 48 monthsPopulation: The number of participants is not available for this study, only clinic-level data was collected.
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.
Outcome measures
| Measure |
Low Support
n=9 Clinics
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
n=11 Clinics
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
n=9 Clinics
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
n=137 Clinics
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.
|
|---|---|---|---|---|
|
Rate Ratio of the Percent of the Clinics' Patients "Indicated" for Statin With a Guideline-appropriate Prescription for Statins
|
1.09 Rate ratio
Interval 1.06 to 1.13
|
1.11 Rate ratio
Interval 1.08 to 1.13
|
1.06 Rate ratio
Interval 1.03 to 1.09
|
1.04 Rate ratio
Interval 1.03 to 1.05
|
PRIMARY outcome
Timeframe: Monthly, up to 48 monthsPopulation: The number of participants is not available for this study, only clinic-level data was collected.
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.
Outcome measures
| Measure |
Low Support
n=9 Clinics
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
n=11 Clinics
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
n=9 Clinics
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
n=137 Clinics
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.
|
|---|---|---|---|---|
|
Rate Ratio of the Percent of the Clinics' Patients "Indicated" for ACE/ARB With Guideline-appropriate Prescription for ACE/ARBs
|
0.95 Rate ratio
Interval 0.92 to 0.97
|
0.99 Rate ratio
Interval 0.97 to 1.01
|
0.99 Rate ratio
Interval 0.96 to 1.02
|
0.95 Rate ratio
Interval 0.94 to 0.95
|
SECONDARY outcome
Timeframe: 3 years post-implementationDescribe the characteristics of clinics that achieve sustained change and of those that do not achieve change
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Monthly, up to 48 monthsPopulation: The number of participants is not available for this study, only clinic-level data was collected.
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.
Outcome measures
| Measure |
Low Support
n=9 Clinics
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
n=11 Clinics
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
n=9 Clinics
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
n=137 Clinics
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.
|
|---|---|---|---|---|
|
Rate Ratio of the Change in the Percent of the Clinic's 'Indicated' Patients With Correct Intensity Statin Prescribing
|
1.24 Rate ratio
Interval 1.21 to 1.28
|
1.35 Rate ratio
Interval 1.31 to 1.39
|
1.11 Rate ratio
Interval 1.08 to 1.15
|
1.17 Rate ratio
Interval 1.16 to 1.18
|
Adverse Events
Low Support
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Medium Support
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
High Support
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Comparison
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place