Mental Health, Psychotic Disorders
Conditions
Keywords
Antipsychotic Agents, Metabolic Syndrome, Quality Improvement
Brief summary
The purpose of this study is to test an approach for implementing guideline recommendations for assessing and managing metabolic side effects (including weight gain, diabetes, elevated lipids) in patients prescribed antipsychotic medications.
Detailed description
Treatment of psychotic disorders consists primarily of antipsychotic medications, which are associated with metabolic side effects such as overweight/obesity, diabetes, and dyslipidemia. Expert consensus and evidence-based recommendations have been developed for assessment and management of these conditions; however, research studies show deficits and delays in metabolic monitoring for patients prescribed antipsychotics. This purpose of this study is to test a quality improvement intervention to enhance implementation of recommendations for assessing and managing metabolic side effects in patients prescribed antipsychotic medications. Study Objectives are: * Objective 1: To test the effect of an Evidence-Based Quality Improvement/Facilitation (EBQI/F) intervention as an augmentation to a national implementation initiative on rates of monitoring for metabolic side effects of antipsychotics in sites likely to encounter greater challenges to implementation. * Objective 2: To test the effect of the EBQI/F intervention as an augmentation to the national implementation initiative on management of metabolic side effects of antipsychotics in sites likely to encounter greater challenges to implementation. * Objective 3: To assess the direct costs of the EBQI/F intervention, and explore potential variations in costs of the EBQI/F intervention in sites with lower versus higher organizational challenges. Methods This study employs a cluster randomized design with eligible study sites including VA Medical Centers with 300 patients receiving a new antipsychotic prescription in the first six months of Fiscal Year 2008. Twelve sites have been recruited and matched according to level of organizational readiness-to-change. Randomization to intervention or control group was conducted within each of the six site-pairs. Study participants include VA employees involved in the monitoring and management of patients treated with antipsychotics at participating sites. The intervention involves researchers partnering with clinical stakeholders, offering tailoring in local implementation strategies to address barriers to metabolic side-effect monitoring and management. External facilitation to support, problem-solve and refine implementation will be provided for a six-month implementation phase. The effectiveness of the EBQI/F intervention combined with the ongoing national quality improvement initiative at six sites (intervention sites) will be compared to six matched comparison sites exposed to the national quality improvement initiative alone (control sites).
Interventions
OTHEREvidence-Based Quality Improvement Plus Facilitation
The intervention involves researchers partnering with clinical stakeholders, offering tailoring in local implementation strategies to address barriers to metabolic side-effect monitoring and management. External facilitation to support, problem-solve and refine implementation will be provided for a six-month implementation phase.
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
\- Providers involved in antipsychotic management or management of metabolic side effects and related conditions
Exclusion criteria
\- None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Site-level Rates of Weight Monitoring at Baseline (Within 30 Days of a New Antipsychotic Prescription) | Change in monitoring rates will be measured monthly through 6-month pre-implementation, implementation, and sustainability phases | For each monthly observation: The proportion of patients at each site due for weight monitoring at baseline who have weight recorded in the electronic health record. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Site-level Rates of Weight Monitoring at Follow-up (From 31-120 Days After a New Antipsychotic Prescription) | Change in monitoring rates will be measured monthly through 6-month pre-implementation, implementation, and sustainability phases | For each monthly observation: The proportion of patients at each site due for weight monitoring at follow-up who have weight recorded in the electronic health record. |
| Change in Site-level Rates of Management for Obesity or Weight Gain Within 30 Days After a Recording of 5% Gain in Body Weight | Change in weight management rates will be measured monthly through 6-month pre-implementation, implementation, and sustainability phases | For each monthly observation: The proportion of patients at each site with weight gain that have guideline-recommended weight management (e.g., counseling about diet or exercise, referral to weight management program) initiated within 30 days. |
Countries
United States
Participant flow
Recruitment details
Twelve sites were recruited, matched according to level of organizational readiness-to-change, and randomized to intervention/control group within each of the 6 site-pairs. Patients with a new antipsychotic medication start were identified using VA data in 6-month pre-implementation, implementation, and sustainability periods.
Pre-assignment details
Participants were continuously entered into the study when starting a new antipsychotic treatment and were assessed up to 120 days later, thus the number of participants within each period is independent of one another and for some participants where the 120 days spanned two periods they are counted in more than one period.
Participants by arm
| Arm | Count |
|---|---|
| Intervention Evidence-Based Quality Improvement plus external facilitation to promote uptake of QI tools and improvement strategies available as part of a national initiative (the MIAMI Project) to disseminate recommendations, QI tools, and improvement strategies relevant to metabolic monitoring and management.
Evidence-Based Quality Improvement Plus Facilitation: The intervention involves researchers partnering with clinical stakeholders, offering tailoring in local implementation strategies to address barriers to metabolic side-effect monitoring and management. External facilitation to support, problem-solve and refine implementation will be provided for a six-month implementation phase. | 11,335 |
| Intervention Evidence-Based Quality Improvement plus external facilitation to promote uptake of QI tools and improvement strategies available as part of a national initiative (the MIAMI Project) to disseminate recommendations, QI tools, and improvement strategies relevant to metabolic monitoring and management.
Evidence-Based Quality Improvement Plus Facilitation: The intervention involves researchers partnering with clinical stakeholders, offering tailoring in local implementation strategies to address barriers to metabolic side-effect monitoring and management. External facilitation to support, problem-solve and refine implementation will be provided for a six-month implementation phase. | 6 |
| Comparison Usual care with access to information about QI tools and improvement strategies, but no Evidence-Based Quality Improvement or Facilitation components. | 8,766 |
| Comparison Usual care with access to information about QI tools and improvement strategies, but no Evidence-Based Quality Improvement or Facilitation components. | 6 |
| Total | 20,113 |
Baseline characteristics
| Characteristic | Total | Comparison | Intervention |
|---|---|---|---|
| Age, Continuous Implementation | 53.35 years STANDARD_DEVIATION 16.29 | 52.82 years STANDARD_DEVIATION 16.64 | 53.75 years STANDARD_DEVIATION 16.02 |
| Age, Continuous Overall Sample | 53.93 years STANDARD_DEVIATION 16.28 | 53.67 years STANDARD_DEVIATION 16.62 | 54.19 years STANDARD_DEVIATION 15.99 |
| Age, Continuous Pre-Implementation | 54.31 years STANDARD_DEVIATION 15.9 | 54.06 years STANDARD_DEVIATION 16.18 | 54.51 years STANDARD_DEVIATION 15.67 |
| Age, Continuous Sustainability | 53.28 years STANDARD_DEVIATION 16.28 | 53.06 years STANDARD_DEVIATION 16.54 | 53.45 years STANDARD_DEVIATION 16.08 |
| Ethnicity (NIH/OMB) Implementation Hispanic or Latino | 372 Participants | 157 Participants | 215 Participants |
| Ethnicity (NIH/OMB) Implementation Not Hispanic or Latino | 7298 Participants | 3101 Participants | 4197 Participants |
| Ethnicity (NIH/OMB) Implementation Unknown or Not Reported | 320 Participants | 186 Participants | 134 Participants |
| Ethnicity (NIH/OMB) Overall Sample Hispanic or Latino | 920 Participants | 423 Participants | 497 Participants |
| Ethnicity (NIH/OMB) Overall Sample Not Hispanic or Latino | 18324 Participants | 7865 Participants | 10459 Participants |
| Ethnicity (NIH/OMB) Overall Sample Unknown or Not Reported | 857 Participants | 478 Participants | 379 Participants |
| Ethnicity (NIH/OMB) Pre-Implementation Hispanic or Latino | 384 Participants | 184 Participants | 200 Participants |
| Ethnicity (NIH/OMB) Pre-Implementation Not Hispanic or Latino | 7735 Participants | 3341 Participants | 4394 Participants |
| Ethnicity (NIH/OMB) Pre-Implementation Unknown or Not Reported | 374 Participants | 189 Participants | 185 Participants |
| Ethnicity (NIH/OMB) Sustainability Hispanic or Latino | 341 Participants | 158 Participants | 183 Participants |
| Ethnicity (NIH/OMB) Sustainability Not Hispanic or Latino | 7093 Participants | 3107 Participants | 3986 Participants |
| Ethnicity (NIH/OMB) Sustainability Unknown or Not Reported | 316 Participants | 179 Participants | 137 Participants |
| Race/Ethnicity, Customized Black | 5030 Participants | 2239 Participants | 2791 Participants |
| Race/Ethnicity, Customized Other | 604 Participants | 206 Participants | 398 Participants |
| Race/Ethnicity, Customized Unknown | 1189 Participants | 493 Participants | 696 Participants |
| Race/Ethnicity, Customized White | 13278 Participants | 5828 Participants | 7450 Participants |
| Region of Enrollment United States | 20101 Participants | 8766 Participants | 11335 Participants |
| Sex: Female, Male Implementation Female | 995 Participants | 433 Participants | 562 Participants |
| Sex: Female, Male Implementation Male | 6995 Participants | 3011 Participants | 3984 Participants |
| Sex: Female, Male Overall Sample Female | 2364 Participants | 1027 Participants | 1337 Participants |
| Sex: Female, Male Overall Sample Male | 17737 Participants | 7739 Participants | 9998 Participants |
| Sex: Female, Male Pre-Implementation Female | 965 Participants | 421 Participants | 544 Participants |
| Sex: Female, Male Pre-Implementation Male | 7528 Participants | 3293 Participants | 4235 Participants |
| Sex: Female, Male Sustainability Female | 965 Participants | 441 Participants | 524 Participants |
| Sex: Female, Male Sustainability Male | 6785 Participants | 3003 Participants | 3782 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 11,335 | 0 / 8,766 |
| serious Total, serious adverse events | 0 / 11,335 | 0 / 8,766 |
Outcome results
Primary
Change in Site-level Rates of Weight Monitoring at Baseline (Within 30 Days of a New Antipsychotic Prescription)
For each monthly observation: The proportion of patients at each site due for weight monitoring at baseline who have weight recorded in the electronic health record.
Time frame: Change in monitoring rates will be measured monthly through 6-month pre-implementation, implementation, and sustainability phases
Population: All patients who met inclusion criteria for this measure. Note that total for Outcome 1 is less than overall total N because patients were included for each measure independently if they met criteria any time in the 6-month implementation phases. Slightly more patients met criteria for the follow-up monitoring measures than baseline monitoring.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intervention | Change in Site-level Rates of Weight Monitoring at Baseline (Within 30 Days of a New Antipsychotic Prescription) | Pre-Implementation | 1811 Participants |
| Intervention | Change in Site-level Rates of Weight Monitoring at Baseline (Within 30 Days of a New Antipsychotic Prescription) | Implementation | 1598 Participants |
| Intervention | Change in Site-level Rates of Weight Monitoring at Baseline (Within 30 Days of a New Antipsychotic Prescription) | Sustainability | 1384 Participants |
| Comparison | Change in Site-level Rates of Weight Monitoring at Baseline (Within 30 Days of a New Antipsychotic Prescription) | Pre-Implementation | 1410 Participants |
| Comparison | Change in Site-level Rates of Weight Monitoring at Baseline (Within 30 Days of a New Antipsychotic Prescription) | Implementation | 1109 Participants |
| Comparison | Change in Site-level Rates of Weight Monitoring at Baseline (Within 30 Days of a New Antipsychotic Prescription) | Sustainability | 1043 Participants |
Comparison: Because of data discontinuity, assumptions for time series analysis did not hold. Repeated measures regression models were developed to compare overall weight monitoring rates at baseline across the implementation phases.95% CI: [1.02, 1.38]
Secondary
Change in Site-level Rates of Management for Obesity or Weight Gain Within 30 Days After a Recording of 5% Gain in Body Weight
For each monthly observation: The proportion of patients at each site with weight gain that have guideline-recommended weight management (e.g., counseling about diet or exercise, referral to weight management program) initiated within 30 days.
Time frame: Change in weight management rates will be measured monthly through 6-month pre-implementation, implementation, and sustainability phases
Population: All patients meeting inclusion/exclusion criteria
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intervention | Change in Site-level Rates of Management for Obesity or Weight Gain Within 30 Days After a Recording of 5% Gain in Body Weight | Sustainability | 50 Participants |
| Intervention | Change in Site-level Rates of Management for Obesity or Weight Gain Within 30 Days After a Recording of 5% Gain in Body Weight | Pre-Implementation | 25 Participants |
| Intervention | Change in Site-level Rates of Management for Obesity or Weight Gain Within 30 Days After a Recording of 5% Gain in Body Weight | Implementation | 46 Participants |
| Comparison | Change in Site-level Rates of Management for Obesity or Weight Gain Within 30 Days After a Recording of 5% Gain in Body Weight | Implementation | 28 Participants |
| Comparison | Change in Site-level Rates of Management for Obesity or Weight Gain Within 30 Days After a Recording of 5% Gain in Body Weight | Sustainability | 65 Participants |
| Comparison | Change in Site-level Rates of Management for Obesity or Weight Gain Within 30 Days After a Recording of 5% Gain in Body Weight | Pre-Implementation | 23 Participants |
Secondary
Change in Site-level Rates of Weight Monitoring at Follow-up (From 31-120 Days After a New Antipsychotic Prescription)
For each monthly observation: The proportion of patients at each site due for weight monitoring at follow-up who have weight recorded in the electronic health record.
Time frame: Change in monitoring rates will be measured monthly through 6-month pre-implementation, implementation, and sustainability phases
Population: All patients meeting inclusion/exclusion criteria
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intervention | Change in Site-level Rates of Weight Monitoring at Follow-up (From 31-120 Days After a New Antipsychotic Prescription) | Pre-Implementation | 1696 Participants |
| Intervention | Change in Site-level Rates of Weight Monitoring at Follow-up (From 31-120 Days After a New Antipsychotic Prescription) | Implementation | 1477 Participants |
| Intervention | Change in Site-level Rates of Weight Monitoring at Follow-up (From 31-120 Days After a New Antipsychotic Prescription) | Sustainability | 1265 Participants |
| Comparison | Change in Site-level Rates of Weight Monitoring at Follow-up (From 31-120 Days After a New Antipsychotic Prescription) | Pre-Implementation | 1337 Participants |
| Comparison | Change in Site-level Rates of Weight Monitoring at Follow-up (From 31-120 Days After a New Antipsychotic Prescription) | Implementation | 1005 Participants |
| Comparison | Change in Site-level Rates of Weight Monitoring at Follow-up (From 31-120 Days After a New Antipsychotic Prescription) | Sustainability | 992 Participants |
Comparison: See comments about time series analysis for primary outcome measure. Repeated measures regression analysis of the likelihood of monitoring for each time period was conducted.95% CI: [1.03, 1.39]