Mental HealthAMMPNCT01875861
Monitoring and Management for Metabolic Side Effects of Antipsychotics
A study testing Evidence-Based Quality Improvement Plus Facilitation in people with Mental Health and Psychotic Disorders, run by VA Office of Research and Development at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mental Health, Psychotic Disorders
- What is being tested?
- Evidence-Based Quality Improvement Plus Facilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to Apr 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Providers involved in antipsychotic management or management of metabolic side effects and related conditions
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR
North Little Rock, Arkansas, 72114-1706
About this study
Official title: Monitoring and Management for Metabolic Effects of Antipsychotics
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.
Read the 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).
- Conditions
- Mental Health, Psychotic Disorders
- Being tested
- Evidence-Based Quality Improvement Plus Facilitation
- Keywords
- Antipsychotic Agents, Metabolic Syndrome, Quality Improvement
- Medical subject headings
- Psychological Well-Being, Psychotic Disorders, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evidence-Based Quality Improvement Plus FacilitationOther
Also called EBQI/F
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 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. Receives: Other: Evidence-Based Quality Improvement Plus Facilitation |
| Comparison | No intervention | "Usual care," in the context of the MIAMI Project. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change in monitoring rates will be measured monthly through 6-month pre-implementation, implementation, and sustainability phases
Secondary outcomes (2)
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.
Measured: 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.
Measured: Change in weight management rates will be measured monthly through 6-month pre-implementation, implementation, and sustainability phases
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2013 (estimated)
- Study startJan 2011
- Primary completionMar 2016
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Mental HealthStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Richard R. Owen, MD, Principal investigator, Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01875861
- Sponsor's protocol ID
- SDP 08-375
- Acronym
- AMMP
- Status last verified
- Feb 2019
- First submitted
- 5 Jun 2013
- Last updated
- 12 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Helfrich CD, Blevins D, Smith JL, Kelly PA, Hogan TP, Hagedorn H, Dubbert PM, Sales AE. Predicting implementation from organizational readiness for change: a study protocol. Implement Sci. 2011 Jul 22;6:76. doi: 10.1186/1748-5908-6-76.
PubMed 21777479Owen RR, Drummond KL, Viverito KM, Marchant K, Pope SK, Smith JL, Landes RD. Monitoring and managing metabolic effects of antipsychotics: a cluster randomized trial of an intervention combining evidence-based quality improvement and external facilitation. Implement Sci. 2013 Oct 8;8:120. doi: 10.1186/1748-5908-8-120.
PubMed 24103648Fortney JC, Owen RR. Increasing treatment engagement for persons with serious mental illness using personal health records. Am J Psychiatry. 2014 Mar;171(3):259-61. doi: 10.1176/appi.ajp.2013.13121701. No abstract available.
PubMed 24585327
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring and Management for Metabolic Effects of Antipsychotics
- ClinicalTrials.gov ID
- NCT01875861
- Acronym / sponsor ID
- AMMP / SDP 08-375
- Conditions
- Mental Health, Psychotic Disorders
- Keywords
- Antipsychotic Agents, Metabolic Syndrome, Quality Improvement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- Jan 2011
- Primary completion
- Mar 2016 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 12 Jun 2013 (estimated)
- Results
- Posted 12 Feb 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Evidence-Based Quality Improvement Plus FacilitationEvidence-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. |
| Comparison | No intervention | –"Usual care," in the context of the MIAMI Project. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Providers involved in antipsychotic management or management of metabolic side effects and related conditions
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Evidence-Based Quality Improvement Plus FacilitationAlso: EBQI/FThe 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. | Other | Intervention |
Primary outcome
Change in Site-level Rates of Weight Monitoring at Baseline (Within 30 Days of a New Antipsychotic Prescription)
Time frame: 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.
2 secondary outcomes
Change in Site-level Rates of Weight Monitoring at Follow-up (From 31-120 Days After a New Antipsychotic Prescription)
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
Time frame: Change in weight management rates will be measured monthly through 6-month pre-implementation, implementation, and sustainability phases
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 21777479Helfrich CD, Blevins D, Smith JL, Kelly PA, Hogan TP, Hagedorn H, Dubbert PM, Sales AE. Predicting implementation from organizational readiness for change: a study protocol. Implement Sci. 2011 Jul 22;6:76. doi: 10.1186/1748-5908-6-76.
- Background: PubMed 24103648Owen RR, Drummond KL, Viverito KM, Marchant K, Pope SK, Smith JL, Landes RD. Monitoring and managing metabolic effects of antipsychotics: a cluster randomized trial of an intervention combining evidence-based quality improvement and external facilitation. Implement Sci. 2013 Oct 8;8:120. doi: 10.1186/1748-5908-8-120.
- Background: PubMed 24585327Fortney JC, Owen RR. Increasing treatment engagement for persons with serious mental illness using personal health records. Am J Psychiatry. 2014 Mar;171(3):259-61. doi: 10.1176/appi.ajp.2013.13121701. No abstract available.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard R. Owen, MD principal investigator
Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Evidence-Based Quality Improvement Plus Facilitation in people with Mental Health and Psychotic Disorders, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Feb 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Site-level Rates of Weight Monitoring at Baseline (Within 30 Days of a New Antipsychotic Prescription) (time frame: Change in monitoring rates will be measured monthly through 6-month pre-implementation, implementation, and sustainability phases). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01875861, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2019; AzTrials last refreshed its copy on 8 Nov 2026.