Major DepressionDIAMONDNCT00781703
Evaluation of a Natural Experiment to Improve Statewide Depression Care in Minnesota (MN)
A study testing DIAMOND depression care model in people with Major Depression, run by HealthPartners Institute.
Trial summary
The study will evaluate a unique natural experiment that aims to transform the primary care of patients with depression. The experiment's aim is to cause statewide implementation of an evidence-based care model for depression by changing the reimbursement system and by using an established regional collaborative (the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Major Depression
- What is being tested?
- DIAMOND depression care model
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,631 participants
- Where
- No sites listed yet
- Study dates
- Feb 2008to Feb 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- major depression
- Patient Health Questionaire (PHQ-9) > 9
- primary care management of depression
Who cannot join
- comorbid psychiatric conditions
About this study
Official title: DIAMOND Study: Evaluation of a Natural Experiment to Improve Statewide Depression Care in MN
The study will evaluate a unique natural experiment that aims to transform the primary care of patients with depression. The experiment's aim is to cause statewide implementation of an evidence-based care model for depression by changing the reimbursement system and by using an established regional collaborative (the Institute for Clinical Systems Improvement) to both facilitate the model's widespread use and certify that medical groups have implemented it. Study hypotheses include the following:
- Newly treated depressed patients in medical groups that have implemented the new reimbursement and facilitation will report receiving higher rates of best care processes than such patients in these medical groups before implementation.
- Rates of best care practices reported to be received by newly treated depressed patients two years after each medical group implements changes will be maintained at least at the rate reported by patients one year post implementation.
- Newly treated depressed patients in medical groups that have participated in the new reimbursement and facilitation will have greater improvement in depression symptoms and work productivity and lower healthcare costs than such patients in groups before participation.
- Medical group measures of priority for improving depression care, capability to manage change, and practice systems will be predictive of more patient-reported best care processes, both at one point in time and in change over time.
Read the detailed description
The study will use a multiple baseline across settings with staggered implementation to test the effects of changed reimbursement and facilitated organizational change on the use and sustainability of evidenced-based care processes for patients with depression. The study will also test the effect of the care process changes on changes in depression symptoms, healthcare costs, and work productivity.
- Conditions
- Major Depression
- Being tested
- DIAMOND depression care model
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DIAMOND depression care modelOther
Patients in activated clinic sites will receive the DIAMOND depression care model, including a care manager, frequent use of the PHQ9, treatment adjustment as indicated, psychiatric consultation, relapse prevention.
| Study group | Role | What they receive |
|---|---|---|
| DIAMOND Care Model | Other | Patients in activated clinic sites will receive the DIAMOND depression care model, including a care manager, frequent use of the Patient Health Questionnaire-9 (PHQ9), treatment adjustment as indicated, psychiatric consultation, relapse prevention. Receives: Other: DIAMOND depression care model |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rates of best care processes
Measured: baseline, 6 months
Secondary outcomes (1)
Improvement in depression symptoms, work productivity and total healthcare costs
Measured: baseline, 3 months, 6 months, 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2008 (estimated)
- Study startFeb 2008
- Primary completionJun 2012
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major DepressionStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 2,631 participants (actual)
Sponsor and investigators
- Lead sponsor
- HealthPartners Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Leif I Solberg, MD, Principal investigator, HealthPartners Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00781703
- Sponsor's protocol ID
- PAR-06-039
- Other IDs
- R01MH080692
- Acronym
- DIAMOND
- Status last verified
- Jul 2014
- First submitted
- 28 Oct 2008
- Last updated
- 15 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DIAMOND Study: Evaluation of a Natural Experiment to Improve Statewide Depression Care in MN
- ClinicalTrials.gov ID
- NCT00781703
- Acronym / sponsor ID
- DIAMOND / PAR-06-039
- Conditions
- Major Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,631 participants (actual)
- Lead sponsor
- HealthPartners InstituteUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Feb 2008
- Primary completion
- Jun 2012 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 29 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study will evaluate a unique natural experiment that aims to transform the primary care of patients with depression. The experiment's aim is to cause statewide implementation of an evidence-based care model for depression by changing the reimbursement system and by using an established regional collaborative (the Institute for Clinical Systems Improvement) to both facilitate the model's widespread use and certify that medical groups have implemented it. Study hypotheses include the following:
- Newly treated depressed patients in medical groups that have implemented the new reimbursement and facilitation will report receiving higher rates of best care processes than such patients in these medical groups before implementation.
- Rates of best care practices reported to be received by newly treated depressed patients two years after each medical group implements changes will be maintained at least at the rate reported by patients one year post implementation.
- Newly treated depressed patients in medical groups that have participated in the new reimbursement and facilitation will have greater improvement in depression symptoms and work productivity and lower healthcare costs than such patients in groups before participation.
- Medical group measures of priority for improving depression care, capability to manage change, and practice systems will be predictive of more patient-reported best care processes, both at one point in time and in change over time.
Detailed description
The study will use a multiple baseline across settings with staggered implementation to test the effects of changed reimbursement and facilitated organizational change on the use and sustainability of evidenced-based care processes for patients with depression. The study will also test the effect of the care process changes on changes in depression symptoms, healthcare costs, and work productivity.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DIAMOND Care Model | Other | Other: DIAMOND depression care modelPatients in activated clinic sites will receive the DIAMOND depression care model, including a care manager, frequent use of the Patient Health Questionnaire-9 (PHQ9), treatment adjustment as indicated, psychiatric consultation, relapse prevention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- major depression
- Patient Health Questionaire (PHQ-9) > 9
- primary care management of depression
Key exclusion criteria (1 listed)
- comorbid psychiatric conditions
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 |
|---|---|---|
| DIAMOND depression care modelPatients in activated clinic sites will receive the DIAMOND depression care model, including a care manager, frequent use of the PHQ9, treatment adjustment as indicated, psychiatric consultation, relapse prevention. | Other | DIAMOND Care Model |
Primary outcome
Rates of best care processes
Time frame: baseline, 6 months
1 secondary outcome
Improvement in depression symptoms, work productivity and total healthcare costs
Time frame: baseline, 3 months, 6 months, 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2014.
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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.
Leif I Solberg, MD principal investigator
HealthPartners Institute
Questions about this trial
What is this clinical trial studying?
A study testing DIAMOND depression care model in people with Major Depression, run by HealthPartners Institute.
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 3 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 15 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Rates of best care processes (time frame: baseline, 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Jul 2014.