An interventional study of Evidence-Based Quality Improvement Plus Facilitation in Mental Health and Psychotic Disorders, sponsored by VA Office of Research and Development. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-02-12.
Sponsored by VA Office of Research and Development · Not applicable, Interventional, and Health services research
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.
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:
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).
1,045 studies on the registry are indexed under Psychological Well-Being; 509 are open to participants now.
This study's enrollment of 12 is below the median of 113 across 888 interventional studies indexed under Psychological Well-Being.
Browse Psychological Well-Being studies →VA Office of Research and Development is the lead sponsor of 1,767 studies on the registry; 394 are open to participants now.
Of its 209 completed or terminated interventional studies of FDA-regulated products, 183 (88%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
- Providers involved in antipsychotic management or management of metabolic side effects and related conditions
Exclusion Criteria:
- None
Evidence-Based Quality Improvement plus external facilitation to promote uptake of quality improvement tools and improvement strategies available as part of a national initiative (the MIAMI Project) to disseminate recommendations, tools, and improvement strategies relevant to metabolic monitoring and management.
Other: Evidence-Based Quality Improvement Plus Facilitation
"Usual care," in the context of the MIAMI Project.
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.
Also known as: EBQI/F
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
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
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
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.
| Milestone | Intervention | Comparison |
|---|---|---|
| Started | 4779 | 3714 |
| Completed | 4779 | 3714 |
| Not completed | 0 | 0 |
| Milestone | Intervention | Comparison |
|---|---|---|
| Started | 4546 | 3444 |
| Completed | 4546 | 3444 |
| Not completed | 0 | 0 |
| Milestone | Intervention | Comparison |
|---|---|---|
| Started | 4306 | 3444 |
| Completed | 4306 | 3444 |
| Not completed | 0 | 0 |
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.
| Participants | Intervention | Comparison |
|---|---|---|
| Pre-Implementation | 1811 | 1410 |
| Implementation | 1598 | 1109 |
| Sustainability | 1384 | 1043 |
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.
| Participants | Intervention | Comparison |
|---|---|---|
| Pre-Implementation | 1696 | 1337 |
| Implementation | 1477 | 1005 |
| Sustainability | 1265 | 992 |
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.
| Participants | Intervention | Comparison |
|---|---|---|
| Pre-Implementation | 25 | 23 |
| Implementation | 46 | 28 |
| Sustainability | 50 | 65 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Intervention | — | 0/11,335 (0%) | 0/11,335 (0%) |
| Comparison | — | 0/8,766 (0%) | 0/8,766 (0%) |
For each outcome measure, patients are selected when a new antipsychotic medication is prescribed. Some patients appear in more than one period (pre-implementation, implementation, sustainability); baseline characteristics are presented for the total sample (N=20,101) with rows for each period.
| Age, Continuous(years) | Intervention | Comparison | Total |
|---|---|---|---|
| Overall Sample | 54.19 ± 15.99 | 53.67 ± 16.62 | 53.93 ± 16.28 |
| Pre-Implementation | 54.51 ± 15.67 | 54.06 ± 16.18 | 54.31 ± 15.9 |
| Implementation | 53.75 ± 16.02 | 52.82 ± 16.64 | 53.35 ± 16.29 |
| Sustainability | 53.45 ± 16.08 | 53.06 ± 16.54 | 53.28 ± 16.28 |
| Sex: Female, Male(Participants) | Intervention | Comparison | Total |
|---|---|---|---|
| Overall Sample — Female | 1337 | 1027 | 2364 |
| Overall Sample — Male | 9998 | 7739 | 17737 |
| Pre-Implementation — Female | 544 | 421 | 965 |
| Pre-Implementation — Male | 4235 | 3293 | 7528 |
| Implementation — Female | 562 | 433 | 995 |
| Implementation — Male | 3984 | 3011 | 6995 |
| Sustainability — Female | 524 | 441 | 965 |
| Sustainability — Male | 3782 | 3003 | 6785 |
| Ethnicity (NIH/OMB)(Participants) | Intervention | Comparison | Total |
|---|---|---|---|
| Overall Sample — Hispanic or Latino | 497 | 423 | 920 |
| Overall Sample — Not Hispanic or Latino | 10459 | 7865 | 18324 |
| Overall Sample — Unknown or Not Reported | 379 | 478 | 857 |
| Pre-Implementation — Hispanic or Latino | 200 | 184 | 384 |
| Pre-Implementation — Not Hispanic or Latino | 4394 | 3341 | 7735 |
| Pre-Implementation — Unknown or Not Reported | 185 | 189 | 374 |
| Implementation — Hispanic or Latino | 215 | 157 | 372 |
| Implementation — Not Hispanic or Latino | 4197 | 3101 | 7298 |
| Implementation — Unknown or Not Reported | 134 | 186 | 320 |
| Sustainability — Hispanic or Latino | 183 | 158 | 341 |
| Sustainability — Not Hispanic or Latino | 3986 | 3107 | 7093 |
| Sustainability — Unknown or Not Reported | 137 | 179 | 316 |
| Race/Ethnicity, Customized(Participants) | Intervention | Comparison | Total |
|---|---|---|---|
| White | 7450 | 5828 | 13278 |
| Black | 2791 | 2239 | 5030 |
| Other | 398 | 206 | 604 |
| Unknown | 696 | 493 | 1189 |
| Region of Enrollment(Participants) | Intervention | Comparison | Total |
|---|---|---|---|
| United States | 11335 | 8766 | 20101 |
Plan to share: No
The record gives a start of Jan 2011, a primary completion of Mar 2016 and a completion of Apr 2017. It does not say whether these dates are actual or estimated.
Results were first posted in Feb 2019, 2 years 11 months after primary completion.
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This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.
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