DepressionDMWNCT01013220
Depression Management at the Workplace
A study testing Depression Product Detailing and Depression HEDIS detailing in people with Depression, run by Florida State University at 1 site in United States.
Trial summary
Randomized trials demonstrate that depression management products can improve clinical and organizational outcomes sufficiently for selected employers to realize a return on investment. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Depression
- What is being tested?
- Depression Product Detailing and Depression HEDIS detailing
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 293 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2009to Sep 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Coalitions who belong to the National Business Coalition on Health are eligible if:
- they have 30+ employer purchasers/affiliates as members
- they act as more than purchasing agents
- (3)they did not participate in the research team's preliminary studies on this topic.
- Employers of participating coalitions are eligible if:
- they are a public or private organization providing health care benefits to 100+ domestic employees
- they have not purchased a depression management product in the past two years.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Colorado Business Group on Health
Denver, Colorado, 80226
About this study
Official title: Influencing Employer Purchasing Behavior
Randomized trials demonstrate that depression management products can improve clinical and organizational outcomes sufficiently for selected employers to realize a return on investment. Rather than usual care marketing which uses voltage-enhanced promises to sell voltage-diminished products, the investigators designed an evidence-based (EB) intervention to encourage employers to purchase a depression management product that offers the type, intensity and duration of care shown to provide clinical and organizational value. In an RCT designed to examine employer benefit purchasing behavior of depression products in 360 employer members of over 20 regional business coalitions, the research team proposes: (a) to compare the impact of evidence-based (EB) to usual care (UC) presentations on employer benefit purchasing behavior, and (b) to identify mediators and organizational moderators of intervention impact on employer benefit purchasing behavior.
This study addresses what policy analysts argue is one of the most pivotal problems in the translation of evidence-based care to 'real world' settings: whether purchasers can be influenced to buy health care products on the basis of value rather than cost. In the likely event that EB > UC, the study will provide encouragement to use an evidence-based approach to market new health care products to private payers on the basis of the product's clinical and organizational value. UC may achieve comparable outcomes to EB if the limiting factors in benefit purchasing are organizational, purchasing group and vendor constraints that no intervention can meaningfully modify. Support for this scenario would encourage the targeted marketing of new products to coalition members with empirically identified organizational, purchasing group and vendor characteristics, using usual care strategies.
- Conditions
- Depression
- Being tested
- Depression Product Detailing, Depression HEDIS detailing
- Keywords
- depression, depression care management, financing, absenteeism, presenteeism, employer decisions to purchase health care benefits
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Depression Product DetailingOther
- two hour academic detailing of depression management products to employees with responsibility for purchasing health care benefits
- technical assistance in purchasing high quality depression management products
Depression HEDIS detailingOther
- academic detailing to employees responsible for purchasing health care benefits on how to use HEDIS indicators for depression to assure their depressed employees receive high quality care for the condition
- technical assistance
| Study group | Role | What they receive |
|---|---|---|
| Depression Product Detailing | Experimental | Employers receive education on how to purchase high quality depression management products to improve the quality of depression treatment depressed employees receive. Materials delivered in this arm of the study are available at www.caremanagementfordepression.org Receives: Other: Depression Product Detailing |
| Depression HEDIS Detailing | Placebo comparator | Employers receive education on how to obtain and use HEDIS depression indicators to encourage health plans to improve the quality of depression treatment depressed employees receive Receives: Other: Depression HEDIS detailing |
What is being measured
The primary outcome is the main question the study is designed to answer.
employer purchase of depression management product
Measured: two years after intervention
Secondary outcomes (1)
fidelity of depression management model purchased to evidence-based models
Measured: two years after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2009 (estimated)
- Study startJan 2009
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 293 participants (actual)
Sponsor and investigators
- Lead sponsor
- Florida State University
- Sponsor type
- University, hospital or other
- Collaborators
- Colorado Business Group on Health, University of South Florida
- Responsible party
- Sponsor
- Investigators
- Kathryn Rost, PhD, Principal investigator, Florida State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01013220
- Sponsor's protocol ID
- R01MH076227
- Acronym
- DMW
- Status last verified
- Dec 2014
- First submitted
- 12 Nov 2009
- Last updated
- 16 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Rost KM, Meng H, Xu S. Work productivity loss from depression: evidence from an employer survey. BMC Health Serv Res. 2014 Dec 18;14:597. doi: 10.1186/s12913-014-0597-y.
PubMed 25519705Rost KM, Marshall D, Xu S. Intervention impact on depression product appraisal and purchasing behavior by employers: a randomized trial. BMC Health Serv Res. 2014 Sep 24;14:426. doi: 10.1186/1472-6963-14-426.
PubMed 25248854
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influencing Employer Purchasing Behavior
- ClinicalTrials.gov ID
- NCT01013220
- Acronym / sponsor ID
- DMW / R01MH076227
- Conditions
- Depression
- Keywords
- depression, depression care management, financing, absenteeism, presenteeism, employer decisions to purchase health care benefits
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 293 participants (actual)
- Lead sponsor
- Florida State UniversityUniversity, hospital or other
- Collaborators
- Colorado Business Group on Health, University of South Florida
- Study start
- Jan 2009
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 13 Nov 2009 (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.
Randomized trials demonstrate that depression management products can improve clinical and organizational outcomes sufficiently for selected employers to realize a return on investment. Rather than usual care marketing which uses voltage-enhanced promises to sell voltage-diminished products, the investigators designed an evidence-based (EB) intervention to encourage employers to purchase a depression management product that offers the type, intensity and duration of care shown to provide clinical and organizational value. In an RCT designed to examine employer benefit purchasing behavior of depression products in 360 employer members of over 20 regional business coalitions, the research team proposes: (a) to compare the impact of evidence-based (EB) to usual care (UC) presentations on employer benefit purchasing behavior, and (b) to identify mediators and organizational moderators of intervention impact on employer benefit purchasing behavior.
This study addresses what policy analysts argue is one of the most pivotal problems in the translation of evidence-based care to 'real world' settings: whether purchasers can be influenced to buy health care products on the basis of value rather than cost. In the likely event that EB > UC, the study will provide encouragement to use an evidence-based approach to market new health care products to private payers on the basis of the product's clinical and organizational value. UC may achieve comparable outcomes to EB if the limiting factors in benefit purchasing are organizational, purchasing group and vendor constraints that no intervention can meaningfully modify. Support for this scenario would encourage the targeted marketing of new products to coalition members with empirically identified organizational, purchasing group and vendor characteristics, using usual care strategies.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Depression Product Detailing | Experimental | Other: Depression Product DetailingEmployers receive education on how to purchase high quality depression management products to improve the quality of depression treatment depressed employees receive. Materials delivered in this arm of the study are available at www.caremanagementfordepression.org |
| Depression HEDIS Detailing | Placebo comparator | Other: Depression HEDIS detailingEmployers receive education on how to obtain and use HEDIS depression indicators to encourage health plans to improve the quality of depression treatment depressed employees receive |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Coalitions who belong to the National Business Coalition on Health are eligible if:
- Employers of participating coalitions are eligible if:
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 |
|---|---|---|
| Depression Product Detailing1. two hour academic detailing of depression management products to employees with responsibility for purchasing health care benefits 2. technical assistance in purchasing high quality depression management products | Other | Depression Product Detailing |
| Depression HEDIS detailing1. academic detailing to employees responsible for purchasing health care benefits on how to use HEDIS indicators for depression to assure their depressed employees receive high quality care for the condition 2. technical assistance | Other | Depression HEDIS Detailing |
Primary outcome
employer purchase of depression management product
Time frame: two years after intervention
1 secondary outcome
fidelity of depression management model purchased to evidence-based models
Time frame: two years after intervention
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 16 Dec 2014.
- Derived from this study: PubMed 25519705Rost KM, Meng H, Xu S. Work productivity loss from depression: evidence from an employer survey. BMC Health Serv Res. 2014 Dec 18;14:597. doi: 10.1186/s12913-014-0597-y.
- Derived from this study: PubMed 25248854Rost KM, Marshall D, Xu S. Intervention impact on depression product appraisal and purchasing behavior by employers: a randomized trial. BMC Health Serv Res. 2014 Sep 24;14:426. doi: 10.1186/1472-6963-14-426.
- materials for academic detailing of depression management productsLink provided by the sponsor.
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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.
Kathryn Rost, PhD principal investigator
Florida State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Depression Product Detailing and Depression HEDIS detailing in people with Depression, run by Florida State University 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 7 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 16 Dec 2014. 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. Some participants in this study may receive a placebo. 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?
employer purchase of depression management product (time frame: two years after intervention). 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 NCT01013220, which also lists 2 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 16 Dec 2014.