Polypharmacy, Insomnia, Anticoagulants
Conditions
Keywords
implementation science, implementation strategy, anticoagulation, polypharmacy, insomnia, medication safety, academic detailing, quality improvement, pragmatic trial
Brief summary
Scientific advances are constantly leading to better treatments. However, it is quite challenging for healthcare systems, including VA, to ask very busy providers to change the way they practice. The MIDAS QUERI program will help providers improve the way they treat VA patients for three common conditions, using specific strategies to ensure the reliable delivery of these treatments. The first project will focus on reducing potentially inappropriate medication (PIM) use using the VIONE practice, developed in VA. The second project will focus on better use of drugs called direct oral anticoagulants (DOACs) for patients with a history of severe blood clots or an abnormal heart rhythm. The third project will focus on increasing the use of cognitive behavioral therapy for insomnia as the first-line treatment for insomnia instead of sleep medications. The investigators will test two implementation approaches to improve medication use within these topics.
Detailed description
Background The adoption and sustainment of evidence-based practices (EBPs) is a challenge within many healthcare systems, especially in settings that have already strived but failed to achieve longer-term goals. The Veterans Affairs (VA) Maintaining Implementation through Dynamic Adaptations (MIDAS) Quality Enhancement Research Initiative (QUERI) program was funded as a series of trials to test multi-component implementation strategies to sustain optimal use of three EBPs: 1) a deprescribing approach intended to reduce potentially inappropriate polypharmacy; 2) appropriate dosing and drug selection of direct-acting anticoagulant medications (DOACs); and 3) use of cognitive behavioral therapy as first-line treatment for insomnia before pharmacologic treatment. We describe the design and methods for a harmonized series of cluster-randomized control trials comparing two implementation strategies. Methods For each trial, we will recruit 8-12 clinics (24-36 total). All will have access to a clinical dashboard that flags patients who may benefit from the target EBP at that clinic and provider. For each trial, clinics will be randomized to one of two implementation strategies to improve use of the EBPs: 1) individual-level academic detailing (AD); or 2) AD plus the team-based Learn. Engage. Act. Process. (LEAP) quality improvement (QI) learning program. The primary outcomes will be operationalized across the three trials as a patient-level dichotomous response (yes/no) indicating patients with potentially inappropriate medications (PIMs) among those who may benefit from the EBP. This outcome will be computed using month-by-month administrative data. Primary comparison between the two implementation strategies will be analyzed using generalized estimating equations (GEE) with clinic-level monthly percent of PIMs as the dependent variable. Primary comparative endpoint will be at 13-18 months post-baseline. Each trial will also be analyzed independently. Discussion MIDAS QUERI trials will focus on fostering sustained use of EBPs that previously had targeted but incomplete implementation. Our implementation approaches are designed to engage frontline clinicians in a dynamic optimization process that integrates use of actionable clinical dashboard data and making incremental changes, designed to be feasible within busy clinical settings.
Interventions
BEHAVIORALAcademic Detailing (AD)
The National Resource Center for Academic Detailing (NaRCAD) describes AD as an innovative, one-on-one outreach education technique that helps clinicians provide evidence-based care to their patients. Using an accurate, up-to-date synthesis of the best clinical evidence in an engaging format, academic detailers ignite clinician behavior change, ultimately improving patient health. A successful AD visit is highly interactive, always a dialogue, and assesses a clinician's individual needs, beliefs, attitudes, issues, and concerns in order to promote better.\[practice\].
BEHAVIORALLEAP
Learn. Engage. Act. Process (LEAP) program is a structured 6-month core curriculum plus 6 monthly collaborative sessions. The LEAP quality improvement program engages frontline teams in sustained incremental improvements of EBPs over a six-month period, allowing space for busy clinicians to learn and immediately apply fundamental QI skills. LEAP encompasses: 1) a structured, accessible curriculum based on the Institute for Healthcare Improvement's (IHI) Model for Improvement and Plan-Do-Study-Act cycles of change; 2) team-based, hands-on learning, and 3) coaching support and a QI network to enhance learning and accountability.
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
The investigators will conduct a series of three trials to test two implementation strategies designed for sustained change. Each trial will be a two-arm, cluster-randomized trial. The results of these trials will be pooled together in a single cross-trial analysis using a dichotomous outcome for each trial. Each trial will also be analyzed independently. Two of the trials will use the same dichotomous primary outcome and the third trial will use a different primary outcome (CBTI). The two arms will both include use of clinical population health dashboards. Unit of analysis is clinic. Clinics will be randomized to one of two implementation strategies described below. Implementation strategies will be tested for effectiveness of sustained use of practices to address documented quality gaps related to (1) potentially inappropriate medications, (2) use of direct oral anticoagulation medications (DOACs), and (3) cognitive behavioral therapy as first-line treatment for insomnia (CBTI).
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
Note- the investigators are recruiting clinics - not individual patients. * Prior to implementation, the investigators will work with sites to ensure they have met the preconditions necessary to begin sustained optimization of the EBP: * a team leader or champion * an identified department with service leadership buy-in and control over the processes/practices impacted by the implementation * readily accessible data to measure process and impact of the implementation and use of the EBP * availability of required resources
Exclusion criteria
N/A
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in the Percentage of Patients With Potentially Inappropriate Medication Use (PIMs) Between Pre- and Post-periods, Across Facilities. | 13-18 months post-baseline | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Percentage of Patients With High-risk Direct Oral Anticoagulant (DOAC) Use Across Facilities | 13-18 months post-baseline | 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. |
| Change in Percentage of Patient Receipt of Any Cognitive Behavioral Therapy for Insomnia (CBTI) Across Facilities | 13-18 months post-baseline | 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. |
| Change in Mean Cognitive Behavioral Therapy for Insomnia (CBTI) Sessions Completed | 13-18 months post-baseline | 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. |
| Change in the Monthly Percentage of Patients Referred to Cognitive Behavioral Therapy for Insomnia (CBTI) Across Facilities | 13-18 months post-baseline | 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. |
| Change in Percentage of Patients With First Line Sleep Medication Across Facilities | 13-18 months post-baseline | 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. |
| Change in Patients With Percentage of Potentially Inappropriate Use of Medications (PIMs) Across Facilities | 13-18 months post-baseline | 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. |
| Change in Monthly Medication Costs for All Drugs Across Facilities | 13-18 months post-baseline | 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. |
| Change in Number of Medication Reviews Across Facilities | 13-18 months post-baseline | 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. |
| Change in Number of Inappropriate Medications at a Patient-level | 13-18 months post-baseline | 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. |
| Change in Percentage of Patients With Direct Oral Anticoagulant (DOAC) Flags Attributable to Chronic Kidney Disease Across Facilities | 13-18 months post-baseline | 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. |
| Change in Percentage of Patients With Direct Oral Anticoagulant (DOAC) Flags Attributable to Weight Across Facilities | 13-18 months post-baseline | 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. |
| Change in Percentage of Patients With Direct Oral Anticoagulant (DOAC) Flags Attributable to Other Mis-dosing Across Facilities | 13-18 months post-baseline | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in Best Places to Work Score | 18-months post-baseline | 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). |
| Change in Workgroup Cohesion & Engagement | 18-months post-baseline | 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. |
| Change in Employee Engagement in Quality Improvement | 18-months Post-baseline | 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. |
| Change in Employee Burnout | 18-months post-baseline | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 79,481 |
| 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. | 12 |
| 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. | 66,208 |
| 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. | 12 |
| Total | 145,713 |
Baseline characteristics
| Characteristic | AD + LEAP Combined | Total | Academic Detailing (AD) Only |
|---|---|---|---|
| Age, Continuous | 66.3 years STANDARD_DEVIATION 15.9 | 66.5 years STANDARD_DEVIATION 16.2 | 66.7 years STANDARD_DEVIATION 16.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2078 Participants | 19671 Participants | 17593 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 62991 Participants | 122984 Participants | 59993 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1139 Participants | 3034 Participants | 1895 Participants |
| Percent of Patients with Overall Inappropriate Medications across trials and facilities at Baseline | 14.1 Percent of patients with PIMs STANDARD_DEVIATION 19.1 | 13.4 Percent of patients with PIMs STANDARD_DEVIATION 16.2 | 12.7 Percent of patients with PIMs STANDARD_DEVIATION 17.1 |
| Race/Ethnicity, Customized Asian | 1552 Participants | 2098 Participants | 546 Participants |
| Race/Ethnicity, Customized Black | 6142 Participants | 15420 Participants | 9278 Participants |
| Race/Ethnicity, Customized Hawaiian-Pacific | 563 Participants | 1090 Participants | 527 Participants |
| Race/Ethnicity, Customized Missing | 5989 Participants | 12822 Participants | 6833 Participants |
| Race/Ethnicity, Customized Native-American/Alaskan Native | 746 Participants | 1178 Participants | 432 Participants |
| Race/Ethnicity, Customized White | 51216 Participants | 113081 Participants | 61865 Participants |
| Sex: Female, Male Female | 4162 Participants | 9363 Participants | 5201 Participants |
| Sex: Female, Male Male | 62042 Participants | 136312 Participants | 74270 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
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.
Time frame: 13-18 months post-baseline
Population: The number of participants analyzed refers to all individuals who were eligible for the cross sectional analysis at any time point in the study .
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Academic Detailing (AD) Only | Change in the Percentage of Patients With Potentially Inappropriate Medication Use (PIMs) Between Pre- and Post-periods, Across Facilities. | -0.133 percentage of patients with PIMs |
| AD + LEAP Combined | Change in the Percentage of Patients With Potentially Inappropriate Medication Use (PIMs) Between Pre- and Post-periods, Across Facilities. | -0.395 percentage of patients with PIMs |
Comparison: 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.p-value: 0.27395% CI: [-0.728, 0.206]Regression, Linear
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.
Time frame: 13-18 months post-baseline
Population: 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).
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.
Time frame: 13-18 months post-baseline
Population: The number of participants refers to all individuals who were eligible for the cross sectional analysis at any time point in the VIONE study.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Academic Detailing (AD) Only | Change in Monthly Medication Costs for All Drugs Across Facilities | 70.73 dollars per patient |
| AD + LEAP Combined | Change in Monthly Medication Costs for All Drugs Across Facilities | 13.72 dollars per patient |
Comparison: Between group comparison is done using between-arm difference (as 'AD+LEAP' minus 'AD only') in within-arm change in medication costs from 6-months pre-baseline period to 6-month post-intervention period (months 13 to 18).95% CI: [-23.3, 69.3]
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.
Time frame: 13-18 months post-baseline
Population: The number of participants refers to all individuals who were eligible for the cross sectional analysis at any time point in the VIONE study.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Academic Detailing (AD) Only | Change in Number of Inappropriate Medications at a Patient-level | -0.00625 percentage of patients with PIMs |
| AD + LEAP Combined | Change in Number of Inappropriate Medications at a Patient-level | -0.05942 percentage of patients with PIMs |
Comparison: Between group comparison is done using between-arm difference (as 'AD+LEAP' minus 'AD only') in within-arm change in count of inappropriate use from 6-months pre-baseline period to 6-month post-intervention period (months 13 to 18)95% CI: [-0.09073, 0.01561]
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.
Time frame: 13-18 months post-baseline
Population: The number of participants refers to all individuals who were eligible for the cross sectional analysis at any time point in the VIONE study.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Academic Detailing (AD) Only | Change in Number of Medication Reviews Across Facilities | -0.00004 number of medication reviews |
| AD + LEAP Combined | Change in Number of Medication Reviews Across Facilities | -0.00064 number of medication reviews |
Comparison: Between group comparison is done using between-arm difference (as 'AD+LEAP' minus 'AD only') in within-arm change in count of medication note reviews from 6-months pre-baseline period to 6-month post-intervention period (months 13 to 18).95% CI: [-1.08, -0.122]
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.
Time frame: 13-18 months post-baseline
Population: The number of participants refers to all individuals who were eligible for the cross sectional analysis at any time point in the VIONE study.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Academic Detailing (AD) Only | Change in Patients With Percentage of Potentially Inappropriate Use of Medications (PIMs) Across Facilities | -0.01756 percentage of patients with PIMs |
| AD + LEAP Combined | Change in Patients With Percentage of Potentially Inappropriate Use of Medications (PIMs) Across Facilities | -0.01618 percentage of patients with PIMs |
Comparison: Between group comparison is done using between-arm difference (as 'AD+LEAP' minus 'AD only') in within-arm change in proportion of PIMs for the post-intervention period (months 13 to 18), controlling for the pre-baseline period (months 0 to 6).95% CI: [-0.0245, 0.0272]
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.
Time frame: 13-18 months post-baseline
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Academic Detailing (AD) Only | Change in Percentage of Patient Receipt of Any Cognitive Behavioral Therapy for Insomnia (CBTI) Across Facilities | -0.00922 percentage of patients receiving CBTI |
| AD + LEAP Combined | Change in Percentage of Patient Receipt of Any Cognitive Behavioral Therapy for Insomnia (CBTI) Across Facilities | 0.00085 percentage of patients receiving CBTI |
Comparison: Between group comparison is done using between-arm difference (as 'AD+LEAP' minus 'AD only') in within-arm change in proportion of CBTI receipt for the post-intervention period (months 13 to 18), controlling for the pre-baseline period (months 0 to 6)95% CI: [-0.02415, 0.04429]
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.
Time frame: 13-18 months post-baseline
Population: The number of participants refers to all individuals who were eligible for the cross sectional analysis at any time point in the DOAC study.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Academic Detailing (AD) Only | Change in Percentage of Patients With Direct Oral Anticoagulant (DOAC) Flags Attributable to Chronic Kidney Disease Across Facilities | 0.31 percentage of patients with a DOAC flag |
| AD + LEAP Combined | Change in Percentage of Patients With Direct Oral Anticoagulant (DOAC) Flags Attributable to Chronic Kidney Disease Across Facilities | 0.11 percentage of patients with a DOAC flag |
Comparison: Between group comparison is done using between-arm difference (as 'AD+LEAP' minus 'AD only') in within-arm change in proportion of of high-risk DOAC use attributable to chronic kidney disease for the post-intervention period (months 13 to 18), controlling for the pre-baseline period (months 0 to 6), ), controlling for the pre-baseline period (months 0 to 6).95% CI: [-0.83, 0.42]
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.
Time frame: 13-18 months post-baseline
Population: The number of participants refers to all individuals who were eligible for the cross sectional analysis at any time point in the DOAC study.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Academic Detailing (AD) Only | Change in Percentage of Patients With Direct Oral Anticoagulant (DOAC) Flags Attributable to Other Mis-dosing Across Facilities | 0.20 percentage of patients with a DOAC flag |
| AD + LEAP Combined | Change in Percentage of Patients With Direct Oral Anticoagulant (DOAC) Flags Attributable to Other Mis-dosing Across Facilities | 0.02 percentage of patients with a DOAC flag |
Comparison: Between group comparison is done using between-arm difference (as 'AD+LEAP' minus 'AD only') in within-arm change in proportion of high-risk DOAC use attributable to mis-dosing for the post-intervention period (months 13 to 18), controlling for the pre-baseline period (months 0 to 6).95% CI: [-0.7, 0.33]
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.
Time frame: 13-18 months post-baseline
Population: The number of participants refers to all individuals who were eligible for the cross sectional analysis at any time point in the DOAC study.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Academic Detailing (AD) Only | Change in Percentage of Patients With Direct Oral Anticoagulant (DOAC) Flags Attributable to Weight Across Facilities | 0.17 percentage of patients with a DOAC flag |
| AD + LEAP Combined | Change in Percentage of Patients With Direct Oral Anticoagulant (DOAC) Flags Attributable to Weight Across Facilities | 0.49 percentage of patients with a DOAC flag |
Comparison: Between group comparison is done using between-arm difference (as 'AD+LEAP' minus 'AD only') in within-arm change in proportion of high-risk DOAC use attributable to weight for the post-intervention period (months 13 to 18), controlling for the pre-baseline period (months 0 to 6).95% CI: [-0.08, 0.72]
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.
Time frame: 13-18 months post-baseline
Population: The number of participants refers to all individuals who were eligible for the cross sectional analysis at any time point in the CBTI study.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Academic Detailing (AD) Only | Change in Percentage of Patients With First Line Sleep Medication Across Facilities | 0.02206 percentage of patients PIMs |
| AD + LEAP Combined | Change in Percentage of Patients With First Line Sleep Medication Across Facilities | -0.06164 percentage of patients PIMs |
Comparison: Between group comparison is done using between-arm difference (as 'AD+LEAP' minus 'AD only') in within-arm change in proportion of PIMs for the post-intervention period (months 13 to 18), controlling for the pre-baseline period (months 0 to 6).95% CI: [-0.21014, 0.04275]
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.
Time frame: 13-18 months post-baseline
Population: The number of participants refers to all individuals who were eligible for the cross sectional analysis at any time point in the DOAC study.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Academic Detailing (AD) Only | Change in Percentage of Patients With High-risk Direct Oral Anticoagulant (DOAC) Use Across Facilities | 0.64 percentage of patients with a DOAC flag |
| AD + LEAP Combined | Change in Percentage of Patients With High-risk Direct Oral Anticoagulant (DOAC) Use Across Facilities | 0.53 percentage of patients with a DOAC flag |
Comparison: Between group comparison is done using between-arm difference (as 'AD+LEAP' minus 'AD only') in within-arm change in proportion of high-risk DOAC use from 6-months pre-baseline period to 6-month post-intervention period (months 13 to 18).95% CI: [-1.44, 1.2]
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.
Time frame: 13-18 months post-baseline
Population: 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.
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).
Time frame: 18-months post-baseline
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Academic Detailing (AD) Only | Change in Best Places to Work Score | 0.170 units on a scale |
| AD + LEAP Combined | Change in Best Places to Work Score | -0.056 units on a scale |
95% CI: [-0.25, 0.452]
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.
Time frame: 18-months post-baseline
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Academic Detailing (AD) Only | Change in Employee Burnout | -0.586 units on a scale |
| AD + LEAP Combined | Change in Employee Burnout | 0.227 units on a scale |
95% CI: [-0.555, 0.477]
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.
Time frame: 18-months Post-baseline
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Academic Detailing (AD) Only | Change in Employee Engagement in Quality Improvement | 0.305 units on a scale |
| AD + LEAP Combined | Change in Employee Engagement in Quality Improvement | 0.247 units on a scale |
95% CI: [-0.216, 0.42]
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.
Time frame: 18-months post-baseline
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Academic Detailing (AD) Only | Change in Workgroup Cohesion & Engagement | 0.131 units on a scale |
| AD + LEAP Combined | Change in Workgroup Cohesion & Engagement | 0.152 units on a scale |
95% CI: [-0.339, 0.254]