Trial Outcomes & Findings for Monitoring and Management for Metabolic Side Effects of Antipsychotics (NCT NCT01875861)
NCT ID: NCT01875861
Last Updated: 2019-02-12
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
12 participants
Primary outcome timeframe
Change in monitoring rates will be measured monthly through 6-month pre-implementation, implementation, and sustainability phases
Results posted on
2019-02-12
Participant Flow
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.
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.
Unit of analysis: Sites
Participant milestones
| Measure |
Intervention
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.
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.
|
Comparison
"Usual care" with access to information about QI tools and improvement strategies, but no Evidence-Based Quality Improvement or Facilitation components.
|
|---|---|---|
|
Pre-implementation
STARTED
|
4779 6
|
3714 6
|
|
Pre-implementation
COMPLETED
|
4779 6
|
3714 6
|
|
Pre-implementation
NOT COMPLETED
|
0 0
|
0 0
|
|
Implementation
STARTED
|
4546 6
|
3444 6
|
|
Implementation
COMPLETED
|
4546 6
|
3444 6
|
|
Implementation
NOT COMPLETED
|
0 0
|
0 0
|
|
Sustainability
STARTED
|
4306 6
|
3444 6
|
|
Sustainability
COMPLETED
|
4306 6
|
3444 6
|
|
Sustainability
NOT COMPLETED
|
0 0
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The total sample size is smaller than the sum of participants in each study period because, according to the study design, patients may be selected for observation in more than one period.
Baseline characteristics by cohort
| Measure |
Intervention
n=6 Sites
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.
|
Comparison
n=6 Sites
"Usual care" with access to information about QI tools and improvement strategies, but no Evidence-Based Quality Improvement or Facilitation components.
|
Total
n=12 Sites
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
Overall Sample
|
54.19 years
STANDARD_DEVIATION 15.99 • n=11335 Participants • The total sample size is smaller than the sum of participants in each study period because, according to the study design, patients may be selected for observation in more than one period.
|
53.67 years
STANDARD_DEVIATION 16.62 • n=8766 Participants • The total sample size is smaller than the sum of participants in each study period because, according to the study design, patients may be selected for observation in more than one period.
|
53.93 years
STANDARD_DEVIATION 16.28 • n=20101 Participants • The total sample size is smaller than the sum of participants in each study period because, according to the study design, patients may be selected for observation in more than one period.
|
|
Age, Continuous
Pre-Implementation
|
54.51 years
STANDARD_DEVIATION 15.67 • n=4779 Participants • The total sample size is smaller than the sum of participants in each study period because, according to the study design, patients may be selected for observation in more than one period.
|
54.06 years
STANDARD_DEVIATION 16.18 • n=3714 Participants • The total sample size is smaller than the sum of participants in each study period because, according to the study design, patients may be selected for observation in more than one period.
|
54.31 years
STANDARD_DEVIATION 15.9 • n=8493 Participants • The total sample size is smaller than the sum of participants in each study period because, according to the study design, patients may be selected for observation in more than one period.
|
|
Age, Continuous
Implementation
|
53.75 years
STANDARD_DEVIATION 16.02 • n=4546 Participants • The total sample size is smaller than the sum of participants in each study period because, according to the study design, patients may be selected for observation in more than one period.
|
52.82 years
STANDARD_DEVIATION 16.64 • n=3444 Participants • The total sample size is smaller than the sum of participants in each study period because, according to the study design, patients may be selected for observation in more than one period.
|
53.35 years
STANDARD_DEVIATION 16.29 • n=7990 Participants • The total sample size is smaller than the sum of participants in each study period because, according to the study design, patients may be selected for observation in more than one period.
|
|
Age, Continuous
Sustainability
|
53.45 years
STANDARD_DEVIATION 16.08 • n=4306 Participants • The total sample size is smaller than the sum of participants in each study period because, according to the study design, patients may be selected for observation in more than one period.
|
53.06 years
STANDARD_DEVIATION 16.54 • n=3444 Participants • The total sample size is smaller than the sum of participants in each study period because, according to the study design, patients may be selected for observation in more than one period.
|
53.28 years
STANDARD_DEVIATION 16.28 • n=7750 Participants • The total sample size is smaller than the sum of participants in each study period because, according to the study design, patients may be selected for observation in more than one period.
|
|
Sex: Female, Male
Overall Sample · Female
|
1337 Participants
n=11335 Participants • The total sample size is smaller than the sum of participants in each study period because, according to the study design, patients may be selected for observation in more than one period.
|
1027 Participants
n=8766 Participants • The total sample size is smaller than the sum of participants in each study period because, according to the study design, patients may be selected for observation in more than one period.
|
2364 Participants
n=20101 Participants • The total sample size is smaller than the sum of participants in each study period because, according to the study design, patients may be selected for observation in more than one period.
|
|
Sex: Female, Male
Overall Sample · Male
|
9998 Participants
n=11335 Participants • The total sample size is smaller than the sum of participants in each study period because, according to the study design, patients may be selected for observation in more than one period.
|
7739 Participants
n=8766 Participants • The total sample size is smaller than the sum of participants in each study period because, according to the study design, patients may be selected for observation in more than one period.
|
17737 Participants
n=20101 Participants • The total sample size is smaller than the sum of participants in each study period because, according to the study design, patients may be selected for observation in more than one period.
|
|
Sex: Female, Male
Pre-Implementation · Female
|
544 Participants
n=4779 Participants • The total sample size is smaller than the sum of participants in each study period because, according to the study design, patients may be selected for observation in more than one period.
|
421 Participants
n=3714 Participants • The total sample size is smaller than the sum of participants in each study period because, according to the study design, patients may be selected for observation in more than one period.
|
965 Participants
n=8493 Participants • The total sample size is smaller than the sum of participants in each study period because, according to the study design, patients may be selected for observation in more than one period.
|
|
Sex: Female, Male
Pre-Implementation · Male
|
4235 Participants
n=4779 Participants • The total sample size is smaller than the sum of participants in each study period because, according to the study design, patients may be selected for observation in more than one period.
|
3293 Participants
n=3714 Participants • The total sample size is smaller than the sum of participants in each study period because, according to the study design, patients may be selected for observation in more than one period.
|
7528 Participants
n=8493 Participants • The total sample size is smaller than the sum of participants in each study period because, according to the study design, patients may be selected for observation in more than one period.
|
|
Sex: Female, Male
Implementation · Female
|
562 Participants
n=4546 Participants • The total sample size is smaller than the sum of participants in each study period because, according to the study design, patients may be selected for observation in more than one period.
|
433 Participants
n=3444 Participants • The total sample size is smaller than the sum of participants in each study period because, according to the study design, patients may be selected for observation in more than one period.
|
995 Participants
n=7990 Participants • The total sample size is smaller than the sum of participants in each study period because, according to the study design, patients may be selected for observation in more than one period.
|
|
Sex: Female, Male
Implementation · Male
|
3984 Participants
n=4546 Participants • The total sample size is smaller than the sum of participants in each study period because, according to the study design, patients may be selected for observation in more than one period.
|
3011 Participants
n=3444 Participants • The total sample size is smaller than the sum of participants in each study period because, according to the study design, patients may be selected for observation in more than one period.
|
6995 Participants
n=7990 Participants • The total sample size is smaller than the sum of participants in each study period because, according to the study design, patients may be selected for observation in more than one period.
|
|
Sex: Female, Male
Sustainability · Female
|
524 Participants
n=4306 Participants • The total sample size is smaller than the sum of participants in each study period because, according to the study design, patients may be selected for observation in more than one period.
|
441 Participants
n=3444 Participants • The total sample size is smaller than the sum of participants in each study period because, according to the study design, patients may be selected for observation in more than one period.
|
965 Participants
n=7750 Participants • The total sample size is smaller than the sum of participants in each study period because, according to the study design, patients may be selected for observation in more than one period.
|
|
Sex: Female, Male
Sustainability · Male
|
3782 Participants
n=4306 Participants • The total sample size is smaller than the sum of participants in each study period because, according to the study design, patients may be selected for observation in more than one period.
|
3003 Participants
n=3444 Participants • The total sample size is smaller than the sum of participants in each study period because, according to the study design, patients may be selected for observation in more than one period.
|
6785 Participants
n=7750 Participants • The total sample size is smaller than the sum of participants in each study period because, according to the study design, patients may be selected for observation in more than one period.
|
|
Ethnicity (NIH/OMB)
Overall Sample · Hispanic or Latino
|
497 Participants
n=11335 Participants • The total sample size is smaller than the sum of participants in each study period because, according to the study design, patients may be selected for observation in more than one period.
|
423 Participants
n=8766 Participants • The total sample size is smaller than the sum of participants in each study period because, according to the study design, patients may be selected for observation in more than one period.
|
920 Participants
n=20101 Participants • The total sample size is smaller than the sum of participants in each study period because, according to the study design, patients may be selected for observation in more than one period.
|
|
Ethnicity (NIH/OMB)
Overall Sample · Not Hispanic or Latino
|
10459 Participants
n=11335 Participants • The total sample size is smaller than the sum of participants in each study period because, according to the study design, patients may be selected for observation in more than one period.
|
7865 Participants
n=8766 Participants • The total sample size is smaller than the sum of participants in each study period because, according to the study design, patients may be selected for observation in more than one period.
|
18324 Participants
n=20101 Participants • The total sample size is smaller than the sum of participants in each study period because, according to the study design, patients may be selected for observation in more than one period.
|
|
Ethnicity (NIH/OMB)
Overall Sample · Unknown or Not Reported
|
379 Participants
n=11335 Participants • The total sample size is smaller than the sum of participants in each study period because, according to the study design, patients may be selected for observation in more than one period.
|
478 Participants
n=8766 Participants • The total sample size is smaller than the sum of participants in each study period because, according to the study design, patients may be selected for observation in more than one period.
|
857 Participants
n=20101 Participants • The total sample size is smaller than the sum of participants in each study period because, according to the study design, patients may be selected for observation in more than one period.
|
|
Ethnicity (NIH/OMB)
Pre-Implementation · Hispanic or Latino
|
200 Participants
n=4779 Participants • The total sample size is smaller than the sum of participants in each study period because, according to the study design, patients may be selected for observation in more than one period.
|
184 Participants
n=3714 Participants • The total sample size is smaller than the sum of participants in each study period because, according to the study design, patients may be selected for observation in more than one period.
|
384 Participants
n=8493 Participants • The total sample size is smaller than the sum of participants in each study period because, according to the study design, patients may be selected for observation in more than one period.
|
|
Ethnicity (NIH/OMB)
Pre-Implementation · Not Hispanic or Latino
|
4394 Participants
n=4779 Participants • The total sample size is smaller than the sum of participants in each study period because, according to the study design, patients may be selected for observation in more than one period.
|
3341 Participants
n=3714 Participants • The total sample size is smaller than the sum of participants in each study period because, according to the study design, patients may be selected for observation in more than one period.
|
7735 Participants
n=8493 Participants • The total sample size is smaller than the sum of participants in each study period because, according to the study design, patients may be selected for observation in more than one period.
|
|
Ethnicity (NIH/OMB)
Pre-Implementation · Unknown or Not Reported
|
185 Participants
n=4779 Participants • The total sample size is smaller than the sum of participants in each study period because, according to the study design, patients may be selected for observation in more than one period.
|
189 Participants
n=3714 Participants • The total sample size is smaller than the sum of participants in each study period because, according to the study design, patients may be selected for observation in more than one period.
|
374 Participants
n=8493 Participants • The total sample size is smaller than the sum of participants in each study period because, according to the study design, patients may be selected for observation in more than one period.
|
|
Ethnicity (NIH/OMB)
Implementation · Hispanic or Latino
|
215 Participants
n=4546 Participants • The total sample size is smaller than the sum of participants in each study period because, according to the study design, patients may be selected for observation in more than one period.
|
157 Participants
n=3444 Participants • The total sample size is smaller than the sum of participants in each study period because, according to the study design, patients may be selected for observation in more than one period.
|
372 Participants
n=7990 Participants • The total sample size is smaller than the sum of participants in each study period because, according to the study design, patients may be selected for observation in more than one period.
|
|
Ethnicity (NIH/OMB)
Implementation · Not Hispanic or Latino
|
4197 Participants
n=4546 Participants • The total sample size is smaller than the sum of participants in each study period because, according to the study design, patients may be selected for observation in more than one period.
|
3101 Participants
n=3444 Participants • The total sample size is smaller than the sum of participants in each study period because, according to the study design, patients may be selected for observation in more than one period.
|
7298 Participants
n=7990 Participants • The total sample size is smaller than the sum of participants in each study period because, according to the study design, patients may be selected for observation in more than one period.
|
|
Ethnicity (NIH/OMB)
Implementation · Unknown or Not Reported
|
134 Participants
n=4546 Participants • The total sample size is smaller than the sum of participants in each study period because, according to the study design, patients may be selected for observation in more than one period.
|
186 Participants
n=3444 Participants • The total sample size is smaller than the sum of participants in each study period because, according to the study design, patients may be selected for observation in more than one period.
|
320 Participants
n=7990 Participants • The total sample size is smaller than the sum of participants in each study period because, according to the study design, patients may be selected for observation in more than one period.
|
|
Ethnicity (NIH/OMB)
Sustainability · Hispanic or Latino
|
183 Participants
n=4306 Participants • The total sample size is smaller than the sum of participants in each study period because, according to the study design, patients may be selected for observation in more than one period.
|
158 Participants
n=3444 Participants • The total sample size is smaller than the sum of participants in each study period because, according to the study design, patients may be selected for observation in more than one period.
|
341 Participants
n=7750 Participants • The total sample size is smaller than the sum of participants in each study period because, according to the study design, patients may be selected for observation in more than one period.
|
|
Ethnicity (NIH/OMB)
Sustainability · Not Hispanic or Latino
|
3986 Participants
n=4306 Participants • The total sample size is smaller than the sum of participants in each study period because, according to the study design, patients may be selected for observation in more than one period.
|
3107 Participants
n=3444 Participants • The total sample size is smaller than the sum of participants in each study period because, according to the study design, patients may be selected for observation in more than one period.
|
7093 Participants
n=7750 Participants • The total sample size is smaller than the sum of participants in each study period because, according to the study design, patients may be selected for observation in more than one period.
|
|
Ethnicity (NIH/OMB)
Sustainability · Unknown or Not Reported
|
137 Participants
n=4306 Participants • The total sample size is smaller than the sum of participants in each study period because, according to the study design, patients may be selected for observation in more than one period.
|
179 Participants
n=3444 Participants • The total sample size is smaller than the sum of participants in each study period because, according to the study design, patients may be selected for observation in more than one period.
|
316 Participants
n=7750 Participants • The total sample size is smaller than the sum of participants in each study period because, according to the study design, patients may be selected for observation in more than one period.
|
|
Race/Ethnicity, Customized
White
|
7450 Participants
n=11335 Participants
|
5828 Participants
n=8766 Participants
|
13278 Participants
n=20101 Participants
|
|
Race/Ethnicity, Customized
Black
|
2791 Participants
n=11335 Participants
|
2239 Participants
n=8766 Participants
|
5030 Participants
n=20101 Participants
|
|
Race/Ethnicity, Customized
Other
|
398 Participants
n=11335 Participants
|
206 Participants
n=8766 Participants
|
604 Participants
n=20101 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
696 Participants
n=11335 Participants
|
493 Participants
n=8766 Participants
|
1189 Participants
n=20101 Participants
|
|
Region of Enrollment
United States
|
11335 Participants
n=11335 Participants
|
8766 Participants
n=8766 Participants
|
20101 Participants
n=20101 Participants
|
PRIMARY outcome
Timeframe: Change in monitoring rates will be measured monthly through 6-month pre-implementation, implementation, and sustainability phasesPopulation: 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."
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.
Outcome measures
| Measure |
Intervention
n=9214 Participants
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.
|
Comparison
n=7213 Participants
"Usual care," in the context of the MIAMI Project.
|
|---|---|---|
|
Change in Site-level Rates of Weight Monitoring at Baseline (Within 30 Days of a New Antipsychotic Prescription)
Pre-Implementation
|
1811 Participants
|
1410 Participants
|
|
Change in Site-level Rates of Weight Monitoring at Baseline (Within 30 Days of a New Antipsychotic Prescription)
Implementation
|
1598 Participants
|
1109 Participants
|
|
Change in Site-level Rates of Weight Monitoring at Baseline (Within 30 Days of a New Antipsychotic Prescription)
Sustainability
|
1384 Participants
|
1043 Participants
|
SECONDARY outcome
Timeframe: Change in monitoring rates will be measured monthly through 6-month pre-implementation, implementation, and sustainability phasesPopulation: All patients meeting inclusion/exclusion criteria
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.
Outcome measures
| Measure |
Intervention
n=9302 Participants
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.
|
Comparison
n=7174 Participants
"Usual care," in the context of the MIAMI Project.
|
|---|---|---|
|
Change in Site-level Rates of Weight Monitoring at Follow-up (From 31-120 Days After a New Antipsychotic Prescription)
Pre-Implementation
|
1696 Participants
|
1337 Participants
|
|
Change in Site-level Rates of Weight Monitoring at Follow-up (From 31-120 Days After a New Antipsychotic Prescription)
Implementation
|
1477 Participants
|
1005 Participants
|
|
Change in Site-level Rates of Weight Monitoring at Follow-up (From 31-120 Days After a New Antipsychotic Prescription)
Sustainability
|
1265 Participants
|
992 Participants
|
SECONDARY outcome
Timeframe: Change in weight management rates will be measured monthly through 6-month pre-implementation, implementation, and sustainability phasesPopulation: All patients meeting inclusion/exclusion criteria
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.
Outcome measures
| Measure |
Intervention
n=586 Participants
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.
|
Comparison
n=379 Participants
"Usual care," in the context of the MIAMI Project.
|
|---|---|---|
|
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
|
23 Participants
|
|
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
|
28 Participants
|
|
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
|
65 Participants
|
Adverse Events
Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Comparison
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Richard Owen
Central Arkansas Veterans Healthcare System
Phone: (501) 257-1710
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place