| Primary | Change in the Percentage of Patients With Potentially Inappropriate Medication Use (PIMs) Between Pre- and Post-periods, Across Facilities. | Percentage of PIMs across AD vs. LEAP+AD facilities were modelled as the difference between post-period and pre-period, using the average from the 1-6-month pre-baseline period as "pre" and the average 13-18-month post-baseline as "post." Data was collected monthly at patient level and collapsed by clinic-month for patients who are at risk of potentially inappropriate medication use. Clinic-month outcome was computed as: 1) VIONE; proportion of patients who possessed one or more medications from the Beers' list of patients 65 or older, actively following with the clinic, and not in hospice/palliative care; 2) DOACs; proportion of patients with flags for potentially inappropriate use on a DOAC safety dashboard of those using DOACs; 3) CBTI; proportion of patients with a new prescription for a sleep medication for insomnia who have not had CBTI of those who are actively followed by the clinic and not in hospice/palliative care. The outcome was analyzed by pooling across all three-EBPs. | The number of participants analyzed refers to all individuals who were eligible for the cross sectional analysis at any time point in the study . | Posted | | Least Squares Mean | 95% Confidence Interval | percentage of patients with PIMs | | 13-18 months post-baseline | VA medical centers and/or clinics | VA medical centers and/or clinics | | ID | Title | Description |
|---|
| OG000 | Academic Detailing (AD) Only | Academic Detailing (AD): Site providers received one-on-one educational sessions between a non-physician professional trained in communication skills and the specific topic area (the Academic Detailer) aimed at increasing the use of the evidence-based practices. | | OG001 | AD + LEAP Combined | Academic Detailing (AD): Site providers received one-on-one educational sessions between a non-physician professional trained in communication skills and the specific topic area (the Academic Detailer) aimed at increasing the use of the evidence-based practices. LEAP: Sites also received the Learn. Engage. Act. Process. (LEAP) program, which is a 6-month quality improvement coaching program plus a 6-month follow-up. |
| | Units | Counts |
|---|
| Participants | | | VA medical centers and/or clinics | |
| | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG000-0.133(-0.481 to 0.2144)
- OG001-0.395(-0.800 to 0.0104)
|
|
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| Between group comparison is done using between-arm difference (as 'AD+LEAP' minus 'AD only') in within-arm change in proportion of PIMs of post-intervention period (months 13 to 18), controlling for use in pre-baseline period (months 0 to 6), averaged across three studies. | Regression, Linear | | 0.273 | Significance level is set at 0.05. | Mean Difference (Net) | -0.261 | Standard Error of the Mean | 0.238 | 2-Sided | 95 | -0.728 | 0.206 | | | Between-arm difference at 13-18 months post-baseline, controlling for rates 1-6 months pre-baseline | | |
|
| Secondary | Change in Patients With Percentage of Potentially Inappropriate Use of Medications (PIMs) Across Facilities | Medications include proton pump inhibitors (PPIs), aspirin, central nervous system (CNS) active medications (muscle relaxants, anti-psychotics, Z-drugs, and benzodiazepines), or anticholinergic drugs. This is the primary outcome for the VIONE trial when analyzed as a stand-alone trial and the VIONE sub-analysis of the overall MIDAS study primary outcome. Percentage of patients with PIMs across AD vs. LEAP+AD facilities were modelled longitudinally using Generalized Estimating Equations (GEE), with a three way-interaction of arm, month of follow-up, and pre-, post-period. Data will was be collected monthly at patient level and collapsed by clinic-month for patients who are at risk of potentially inappropriate medication use. Estimates computed using least squares (LS) means from the GEE model. | The number of participants refers to all individuals who were eligible for the cross sectional analysis at any time point in the VIONE study. | Posted | | Least Squares Mean | 95% Confidence Interval | percentage of patients with PIMs | | 13-18 months post-baseline | VA medical centers and/or clinics | VA medical centers and/or clinics | | ID | Title | Description |
|---|
| OG000 | Academic Detailing (AD) Only | Academic Detailing (AD): Site providers received one-on-one educational sessions between a non-physician professional trained in communication skills and the specific topic area (the Academic Detailer) aimed at increasing the use of the evidence-based practices. | | OG001 | AD + LEAP Combined |
|
| Secondary | Change in Monthly Medication Costs for All Drugs Across Facilities | Cost of all drugs without regard to appropriateness. Average monthly cost per patient across LEAP vs. LEAP + AD facilities were modelled longitudinally with a Generalized Linear Model with a Gamma Link and a three-way interaction of arm, month of follow-up and pre-, post-period. Estimates computed using LS means from the GEE model. This will be a secondary outcome for the VIONE trial when analyzed as a stand-alone trial. | The number of participants refers to all individuals who were eligible for the cross sectional analysis at any time point in the VIONE study. | Posted | | Least Squares Mean | 95% Confidence Interval | dollars per patient | | 13-18 months post-baseline | VA medical centers and/or clinics | VA medical centers and/or clinics | | ID | Title | Description |
|---|
| OG000 | Academic Detailing (AD) Only | Academic Detailing (AD): Site providers received one-on-one educational sessions between a non-physician professional trained in communication skills and the specific topic area (the Academic Detailer) aimed at increasing the use of the evidence-based practices. | | OG001 | AD + LEAP Combined | Academic Detailing (AD): Site providers received one-on-one educational sessions between a non-physician professional trained in communication skills and the specific topic area (the Academic Detailer) aimed at increasing the use of the evidence-based practices. LEAP: Sites also received the Learn. Engage. Act. Process. (LEAP) program, which is a 6-month quality improvement coaching program plus a 6-month follow-up. = |
|
| Secondary | Change in Number of Medication Reviews Across Facilities | Number of medication reviews completed by a pharmacist. This will be a secondary outcome for the VIONE trial when analyzed as a stand-alone trial. | The number of participants refers to all individuals who were eligible for the cross sectional analysis at any time point in the VIONE study. | Posted | | Least Squares Mean | 95% Confidence Interval | number of medication reviews | | 13-18 months post-baseline | VA medical centers and/or clinics | VA medical centers and/or clinics | | ID | Title | Description |
|---|
| OG000 | Academic Detailing (AD) Only | Academic Detailing (AD): Site providers received one-on-one educational sessions between a non-physician professional trained in communication skills and the specific topic area (the Academic Detailer) aimed at increasing the use of the evidence-based practices. | | OG001 | AD + LEAP Combined | Academic Detailing (AD): Site providers received one-on-one educational sessions between a non-physician professional trained in communication skills and the specific topic area (the Academic Detailer) aimed at increasing the use of the evidence-based practices. LEAP: Sites also received the Learn. Engage. Act. Process. (LEAP) program, which is a 6-month quality improvement coaching program plus a 6-month follow-up. |
| |
| Secondary | Change in Number of Inappropriate Medications at a Patient-level | This is a measure of count of medications used at the patient (not facility) level. This will be a secondary outcome for the VIONE trial when analyzed as a stand-alone trial. | The number of participants refers to all individuals who were eligible for the cross sectional analysis at any time point in the VIONE study. | Posted | | Least Squares Mean | 95% Confidence Interval | percentage of patients with PIMs | | 13-18 months post-baseline | VA medical centers and/or clinics | VA medical centers and/or clinics | | ID | Title | Description |
|---|
| OG000 | Academic Detailing (AD) Only | Academic Detailing (AD): Site providers received one-on-one educational sessions between a non-physician professional trained in communication skills and the specific topic area (the Academic Detailer) aimed at increasing the use of the evidence-based practices. | | OG001 | AD + LEAP Combined | Academic Detailing (AD): Site providers received one-on-one educational sessions between a non-physician professional trained in communication skills and the specific topic area (the Academic Detailer) aimed at increasing the use of the evidence-based practices. LEAP: Sites also received the Learn. Engage. Act. Process. (LEAP) program, which is a 6-month quality improvement coaching program plus a 6-month follow-up. |
| |
| Secondary | Change in Percentage of Patients With High-risk Direct Oral Anticoagulant (DOAC) Use Across Facilities | High-risk DOAC use will be assessed by "flags" using the algorithm from an operations DOAC dashboard. These flags were developed based on existing guidelines and advice of many anticoagulation experts. Percentage of patients with PIMs across AD vs. LEAP+AD facilities were modelled longitudinally using Generalized Estimating Equations, with a three way-interaction of arm, month of follow-up, and pre-, post-period. Data will was be collected monthly at patient level and collapsed by clinic-month for patients who are at risk of potentially inappropriate medication use. Estimates computed using LS means from the GEE model. This is the primary outcome for the DOAC trial when analyzed as a stand-alone trial and the DOAC sub-analysis of the overall MIDAS study primary outcome. | The number of participants refers to all individuals who were eligible for the cross sectional analysis at any time point in the DOAC study. | Posted | | Least Squares Mean | 95% Confidence Interval | percentage of patients with a DOAC flag | | 13-18 months post-baseline | VA medical centers and/or clinics | VA medical centers and/or clinics | | ID | Title | Description |
|---|
| OG000 | Academic Detailing (AD) Only | Academic Detailing (AD): Site providers received one-on-one educational sessions between a non-physician professional trained in communication skills and the specific topic area (the Academic Detailer) aimed at increasing the use of the evidence-based practices. | | OG001 | AD + LEAP Combined |
|
| Secondary | Change in Percentage of Patients With Direct Oral Anticoagulant (DOAC) Flags Attributable to Chronic Kidney Disease Across Facilities | This was the subset of patients with DOAC Population Health Management Tool (Dashboard) flags that occur when medications are given at doses that would be appropriate but are not because the patient has abnormal renal function. This has had minimal adjustments since being described in previous publications. | The number of participants refers to all individuals who were eligible for the cross sectional analysis at any time point in the DOAC study. | Posted | | Least Squares Mean | 95% Confidence Interval | percentage of patients with a DOAC flag | | 13-18 months post-baseline | VA medical centers and/or clinics | VA medical centers and/or clinics | | ID | Title | Description |
|---|
| OG000 | Academic Detailing (AD) Only | Academic Detailing (AD): Site providers received one-on-one educational sessions between a non-physician professional trained in communication skills and the specific topic area (the Academic Detailer) aimed at increasing the use of the evidence-based practices. | | OG001 | AD + LEAP Combined | Academic Detailing (AD): Site providers received one-on-one educational sessions between a non-physician professional trained in communication skills and the specific topic area (the Academic Detailer) aimed at increasing the use of the evidence-based practices. LEAP: Sites also received the Learn. Engage. Act. Process. (LEAP) program, which is a 6-month quality improvement coaching program plus a 6-month follow-up. |
|
| Secondary | Change in Percentage of Patients With Direct Oral Anticoagulant (DOAC) Flags Attributable to Weight Across Facilities | This was the subset of patients with DOAC Population Health Management Tool (Dashboard) flags that occur when medications are given at doses that would be appropriate but are not because the patient has unusually high or low weight or BMI. This has had minimal adjustments since being described in previous publications. | The number of participants refers to all individuals who were eligible for the cross sectional analysis at any time point in the DOAC study. | Posted | | Least Squares Mean | 95% Confidence Interval | percentage of patients with a DOAC flag | | 13-18 months post-baseline | VA medical centers and/or clinics | VA medical centers and/or clinics | | ID | Title | Description |
|---|
| OG000 | Academic Detailing (AD) Only | Academic Detailing (AD): Site providers received one-on-one educational sessions between a non-physician professional trained in communication skills and the specific topic area (the Academic Detailer) aimed at increasing the use of the evidence-based practices. | | OG001 | AD + LEAP Combined | Academic Detailing (AD): Site providers received one-on-one educational sessions between a non-physician professional trained in communication skills and the specific topic area (the Academic Detailer) aimed at increasing the use of the evidence-based practices. LEAP: Sites also received the Learn. Engage. Act. Process. (LEAP) program, which is a 6-month quality improvement coaching program plus a 6-month follow-up. |
|
| Secondary | Change in Percentage of Patients With Direct Oral Anticoagulant (DOAC) Flags Attributable to Other Mis-dosing Across Facilities | These are the remaining high-risk flags and are usually due to patients with medication interactions or doses that are incorrect due to the indication. This has had minimal adjustments since being described in previous publications. | The number of participants refers to all individuals who were eligible for the cross sectional analysis at any time point in the DOAC study. | Posted | | Least Squares Mean | 95% Confidence Interval | percentage of patients with a DOAC flag | | 13-18 months post-baseline | VA medical centers and/or clinics | VA medical centers and/or clinics | | ID | Title | Description |
|---|
| OG000 | Academic Detailing (AD) Only | Academic Detailing (AD): Site providers received one-on-one educational sessions between a non-physician professional trained in communication skills and the specific topic area (the Academic Detailer) aimed at increasing the use of the evidence-based practices. | | OG001 | AD + LEAP Combined | Academic Detailing (AD): Site providers received one-on-one educational sessions between a non-physician professional trained in communication skills and the specific topic area (the Academic Detailer) aimed at increasing the use of the evidence-based practices. LEAP: Sites also received the Learn. Engage. Act. Process. (LEAP) program, which is a 6-month quality improvement coaching program plus a 6-month follow-up. |
|
| Secondary | Change in Percentage of Patient Receipt of Any Cognitive Behavioral Therapy for Insomnia (CBTI) Across Facilities | Patient receipt of any CBTI will be measured by extracting from the medical records CBTI note templates completed by CBTI therapists. The denominator will consist of primary care patients who are not in hospice/palliative care. Percentage of PIMs across AD vs. LEAP+AD facilities were modelled longitudinally using Generalized Estimating Equations, with a three way-interaction of arm, month of follow-up, and pre-, post-period. Data will was be collected monthly at patient level and collapsed by clinic-month for patients who are at risk of potentially inappropriate medication use. Estimates computed using LS means from the GEE model. This will be the primary outcome for the CBTI trial when analyzed as a stand-alone trial. | The number of participants refers to all individuals who were eligible for the cross sectional analysis at any time point in the CBT-I study. | Posted | | Least Squares Mean | 95% Confidence Interval | percentage of patients receiving CBTI | | 13-18 months post-baseline | VA medical centers and/or clinics | VA medical centers and/or clinics | | ID | Title | Description |
|---|
| OG000 | Academic Detailing (AD) Only | Academic Detailing (AD): Site providers received one-on-one educational sessions between a non-physician professional trained in communication skills and the specific topic area (the Academic Detailer) aimed at increasing the use of the evidence-based practices. | | OG001 | AD + LEAP Combined |
|
| Secondary | Change in Mean Cognitive Behavioral Therapy for Insomnia (CBTI) Sessions Completed | Mean number of sessions will be measured by extracting from the medical records CBTI note templates completed by CBTI therapists. The denominator will consist of primary care patients who are not in hospice/palliative care. This will be a secondary outcome for the CBTI trial when analyzed as a stand-alone trial. | After conducting additional testing of our algorithm for detecting CBTI sessions, we found the algorithm to be adequately sensitive to detecting *any* CBTI but not accurate for detecting the number of CBTI sessions (e.g., CBTI could often be mentioned in the context of a referral or some other ongoing treatment). | Posted | | | | | | 13-18 months post-baseline | | | | ID | Title | Description |
|---|
| OG000 | Academic Detailing (AD) Only | Academic Detailing (AD): Site providers received one-on-one educational sessions between a non-physician professional trained in communication skills and the specific topic area (the Academic Detailer) aimed at increasing the use of the evidence-based practices. | | OG001 | AD + LEAP Combined | Academic Detailing (AD): Site providers received one-on-one educational sessions between a non-physician professional trained in communication skills and the specific topic area (the Academic Detailer) aimed at increasing the use of the evidence-based practices. LEAP: Sites also received the Learn. Engage. Act. Process. (LEAP) program, which is a 6-month quality improvement coaching program plus a 6-month follow-up. |
|
| Secondary | Change in the Monthly Percentage of Patients Referred to Cognitive Behavioral Therapy for Insomnia (CBTI) Across Facilities | CBTI referrals will be measured according to counts of CBTI consult requests in the medical record. For clinics that do not use medical record consult requests specific to CBTI, referrals will be measured using monthly counts provided by CBTI therapists. The denominator will consist of primary care patients who are not in hospice/palliative care. This will be a secondary outcome for the CBTI trial when analyzed as a stand-alone trial. | It was originally planned for all CBTI sites to provide information regarding where in the medical records the investigators could identify referrals. However, prior to launching the trial, it was determined several of the sites' processes for referrals were not distinguishable as referrals vs. other forms of communication (e.g., adding a therapist as a cosigner to a note), making collection of this data impractical and not conducted. Thus, we did not have any sites collect referral information. | Posted | | | | | | 13-18 months post-baseline | | | | ID | Title | Description |
|---|
| OG000 | Academic Detailing (AD) Only | Academic Detailing (AD): Site providers received one-on-one educational sessions between a non-physician professional trained in communication skills and the specific topic area (the Academic Detailer) aimed at increasing the use of the evidence-based practices. | | OG001 | AD + LEAP Combined | Academic Detailing (AD): Site providers received one-on-one educational sessions between a non-physician professional trained in communication skills and the specific topic area (the Academic Detailer) aimed at increasing the use of the evidence-based practices. LEAP: Sites also received the Learn. Engage. Act. Process. (LEAP) program, which is a 6-month quality improvement coaching program plus a 6-month follow-up. |
|
| Secondary | Change in Percentage of Patients With First Line Sleep Medication Across Facilities | The proportion of patients with a new prescription for a sleep medication for insomnia who have not had CBTI of those who are actively followed by the clinic and not in hospice/palliative care. This is a CBTI sub-analysis of the overall MIDAS study primary outcome. | The number of participants refers to all individuals who were eligible for the cross sectional analysis at any time point in the CBTI study. | Posted | | Least Squares Mean | 95% Confidence Interval | percentage of patients PIMs | | 13-18 months post-baseline | VA medical centers and/or clinics | VA medical centers and/or clinics | | ID | Title | Description |
|---|
| OG000 | Academic Detailing (AD) Only | Academic Detailing (AD): Site providers received one-on-one educational sessions between a non-physician professional trained in communication skills and the specific topic area (the Academic Detailer) aimed at increasing the use of the evidence-based practices. | | OG001 | AD + LEAP Combined | Academic Detailing (AD): Site providers received one-on-one educational sessions between a non-physician professional trained in communication skills and the specific topic area (the Academic Detailer) aimed at increasing the use of the evidence-based practices. LEAP: Sites also received the Learn. Engage. Act. Process. (LEAP) program, which is a 6-month quality improvement coaching program plus a 6-month follow-up. = |
|
| Other Pre-specified | Change in Employee Engagement in Quality Improvement | 3-item pilot measure of the extent to which employees engage in quality improvement activities given both at baseline and 18-months post-implementation. Scores are 1-5 with higher ratings indicating more engagement in quality improvement. | The number of participants refers to those eligible for AD and/or LEAP participation at baseline and those who participated in AD and/or LEAP at post-implementation. | Posted | | Least Squares Mean | 95% Confidence Interval | units on a scale | | 18-months Post-baseline | | | | ID | Title | Description |
|---|
| OG000 | Academic Detailing (AD) Only | Academic Detailing (AD): Site providers received one-on-one educational sessions between a non-physician professional trained in communication skills and the specific topic area (the Academic Detailer) aimed at increasing the use of the evidence-based practices. | | OG001 | AD + LEAP Combined | Academic Detailing (AD): Site providers received one-on-one educational sessions between a non-physician professional trained in communication skills and the specific topic area (the Academic Detailer) aimed at increasing the use of the evidence-based practices. LEAP: Sites also received the Learn. Engage. Act. Process. (LEAP) program, which is a 6-month quality improvement coaching program plus a 6-month follow-up. |
| |
| Other Pre-specified | Change in Employee Burnout | 3-item measure comprising one item each for exhaustion, depersonalization, and reduced achievement (reverse scored) given both at baseline and 18-months post-implementation. "High Burnout" measures the percent of staff who are feeling burned out on all three burnout items at a frequency of "once a week" to "every day." Scored: 0-100%, where LOWER score is more favorable. | The number of participants refers to those eligible for AD and/or LEAP participation at baseline and/or those who participated in AD and/or LEAP at post-implementation. | Posted | | Least Squares Mean | 95% Confidence Interval | units on a scale | | 18-months post-baseline | | | | ID | Title | Description |
|---|
| OG000 | Academic Detailing (AD) Only | Academic Detailing (AD): Site providers received one-on-one educational sessions between a non-physician professional trained in communication skills and the specific topic area (the Academic Detailer) aimed at increasing the use of the evidence-based practices. | | OG001 | AD + LEAP Combined | Academic Detailing (AD): Site providers received one-on-one educational sessions between a non-physician professional trained in communication skills and the specific topic area (the Academic Detailer) aimed at increasing the use of the evidence-based practices. LEAP: Sites also received the Learn. Engage. Act. Process. (LEAP) program, which is a 6-month quality improvement coaching program plus a 6-month follow-up. |
|
| Other Pre-specified | Change in Best Places to Work Score | 3-item scale. "Best Places to Work" (BPTW) is a summary measure of the group's satisfaction with the job, organization, and likelihood to recommend VA as a good place to work given both at baseline and 18-months post-implementation. The values are 1 to 5 with a higher score being more positive and the BPTW score is the average of the 3 questions. This is a measure normally administered within the All-employee Survey (AES) and the questions come from the Partnership for Public Service's BPTW survey (http://bestplacestowork.org). | The number of participants refers to those eligible for AD and/or LEAP participation at baseline and those who participated in AD and/or LEAP at post-implementation. | Posted | | Least Squares Mean | 95% Confidence Interval | units on a scale | | 18-months post-baseline | | | | ID | Title | Description |
|---|
| OG000 | Academic Detailing (AD) Only | Academic Detailing (AD): Site providers received one-on-one educational sessions between a non-physician professional trained in communication skills and the specific topic area (the Academic Detailer) aimed at increasing the use of the evidence-based practices. | | OG001 | AD + LEAP Combined | Academic Detailing (AD): Site providers received one-on-one educational sessions between a non-physician professional trained in communication skills and the specific topic area (the Academic Detailer) aimed at increasing the use of the evidence-based practices. LEAP: Sites also received the Learn. Engage. Act. Process. (LEAP) program, which is a 6-month quality improvement coaching program plus a 6-month follow-up. |
|
| Other Pre-specified | Change in Workgroup Cohesion & Engagement | 7-item measure from the VA's newly developed Patient Safety Culture given both at baseline and 18-months post-implementation. Values 1 to 5 where higher values indicate more positive scores. | The number of participants refers to those eligible for AD and/or LEAP participation at baseline and/or those who participated in AD and/or LEAP at post-implementation. | Posted | | Least Squares Mean | 95% Confidence Interval | units on a scale | | 18-months post-baseline | | | | ID | Title | Description |
|---|
| OG000 | Academic Detailing (AD) Only | Academic Detailing (AD): Site providers received one-on-one educational sessions between a non-physician professional trained in communication skills and the specific topic area (the Academic Detailer) aimed at increasing the use of the evidence-based practices. | | OG001 | AD + LEAP Combined | Academic Detailing (AD): Site providers received one-on-one educational sessions between a non-physician professional trained in communication skills and the specific topic area (the Academic Detailer) aimed at increasing the use of the evidence-based practices. LEAP: Sites also received the Learn. Engage. Act. Process. (LEAP) program, which is a 6-month quality improvement coaching program plus a 6-month follow-up. |
| |