DepressionCMPDNCT01773629
Care Managers for Perinatal Depression (CMPD)
A study testing Intervention in people with Depression and Pregnancy, run by Lancaster General Hospital at 4 sites in United States.
Trial summary
The investigators will evaluate effects of introducing the care manager on: 1. Patient receipt of timely diagnosis and initiation of treatment for major depression (diagnosis within 2 weeks of screening and treatment within 1 month of diagnosis); and 2. Read more about this study
- Who is it for?
- Ages 13 years and older, women only
- Conditions the study is for
- Depression, Pregnancy
- What is being tested?
- Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 194 participants
- Where
- 4 sitesUnited States
- Study dates
- Sep 2010to Dec 2013
- 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 13 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Female
- Current pregnancy or experienced pregnancy in the past 6 weeks
- Score >= 12 on PHQ9
Who cannot join
- < age 13
- Mental illness
- Primary language other than English or Spanish
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Downtown Family Medicine
Lancaster, Pennsylvania, 17604
Southeast Lancaster Health Services
Lancaster, Pennsylvania, 17608
Broad Street Health Center
Philadelphia, Pennsylvania, 19122
Haddington Health Center
Philadelphia, Pennsylvania, 19139
About this study
The investigators will evaluate effects of introducing the care manager on:
- Patient receipt of timely diagnosis and initiation of treatment for major depression (diagnosis within 2 weeks of screening and treatment within 1 month of diagnosis); and
- Patient continuity of care for depression across the transition of care from pregnancy to postpartum (within 4 months postpartum).
Read the detailed description
The first two specific research aims of this proposed randomized study will evaluate the benefits of introducing site specific care managers into established multi-component enhancements of perinatal depression care. The four study sites are members of the IMPLICIT perinatal quality improvement network and provide prenatal care to a diverse population of low income minority women using a common set of care processes within diverse practice models including Obstetric, Family Medicine, and Nurse Practitioner/Midwifery settings. The established processes of care include evidence based screening, diagnosis, treatment protocols and quality improvement care teams.
The investigators will evaluate effects of introducing the care manager on:
- Patient receipt of timely diagnosis and initiation of treatment for major depression (diagnosis within 2 weeks of screening and treatment within 1 month of diagnosis); and
- Patient continuity of care for depression across the transition of care from pregnancy to postpartum (within 4 months postpartum).
For the third and fourth specific research aims we will conduct supplementary econometric and qualitative analyses to aid in understanding the provider and system context in which this intervention is implemented across the four study sites. Results of this evaluation will be used to understand for whom and in which systems of care this model is most successful as well as the costs of delivering this intervention.
Specifically the investigators will:
- Employ econometric techniques to quantify the costs of implementing and maintaining the IMPLICIT collaborative care maternal depression intervention; and
- Develop institutional ethnographies of the four study sites and identify factors associated with relative success in implementing perinatal depression care managers and improving timely diagnosis, initiation, and continuity of depression care.
Achieving these aims will provide the foundation for dissemination of this innovative approach to perinatal depression care delivery throughout the entire growing IMPLICIT network which now extends across the northeast and mid-Atlantic regions of the US; sites which provide perinatal care for low income minority women in urban, rural, and suburban communities. These sites include prenatal practices in the Robert Wood Johnson Foundation Aligning Forces for Quality initiative, the Healthy York County Coalition which is partnering with us to disseminate this work in their region.
- Conditions
- Depression, Pregnancy
- Being tested
- Intervention, Control
- Keywords
- Depression, Pregnancy, Postpartum, Perinatal
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterventionOther
Participants in the intervention arm will receive standard care plus the addition of a care manager. Care managers will function to provide culturally competent and linguistically appropriate support for the care of women identified as being at high risk for depression in pregnancy. Working with both the care providers and these study participants care managers will serve as connectors, coaches, collaborators, and negotiators working to overcome barriers to depression care delivery.
ControlOther
Standard of care: within the current care processes, a woman initiating prenatal care completes a depression risk assessment using a two-step approach. Women with high risk of depression are then scheduled for a separate visit with a member of the care team (a physician, psychologist, or other mental health provider) referred to as a "perinatal depression champion" for a timely formal diagnostic interview.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Participants in the intervention arm will receive standard care plus the addition of a care manager. Care managers will function to provide culturally competent and linguistically appropriate support for the care of women identified as being at high risk for depression in pregnancy. Working with both the care providers and these study participants care managers will serve as connectors, coaches, collaborators, and negotiators working to overcome barriers to depression care delivery. Receives: Other: Intervention |
| Control | Other | Standard of care: within the current care processes, a woman initiating prenatal care completes a depression risk assessment using a two-step approach. Women with high risk of depression are then scheduled for a separate visit with a member of the care team (a physician, psychologist, or other mental health provider) referred to as a "perinatal depression champion" for a timely formal diagnostic interview. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnosis of major depression within 2 weeks of screening
Patient receipt of timely diagnosis for major depression during perinatal period.
Measured: 2 weeks after screening
Treatment of major depression within 1 month of diagnosis
Patient receipt of timely initiation of treatment for major depression during the perinatal period.
Measured: 1 month
Transition of care from pregnancy to postpartum
Patient continuity of care for depression across the transition of care from pregnancy to postpartum within 4 months postpartum.
Measured: 4 months
Secondary outcomes (2)
Quantify the costs of implementing a care manager
Employ econometric techniques to quantify the costs of implementing and maintaining the care manager for managing perinatal depression.
Measured: 3 years
Qualitative assessment of success in implementation of perinatal depression care management process.
Develop institutional ethnographies of the study sites and identify factors associated with relative success in implementing perinatal depression care managers and improving timely diagnosis, initiation, and continuity of depression care. Qualitative measures include efficacy of core implementation group, commitment of implementation group, commitment of user group and readiness to change.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2013 (estimated)
- Study startSep 2010
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- None (open label)
- Enrolment
- 194 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lancaster General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pennsylvania, Robert Wood Johnson Foundation
- Responsible party
- Sponsor
- Investigators
- Stephen Ratcliffe, MD, MSPH, Principal investigator, Lancaster General HospitalIan M Bennett, MD, PhD, Principal investigator, University of PennsylvaniaDonna Cohen, MD, MS, Principal investigator, Lancaster General HospitalMichael A Horst, PhD, MPHS, MS, Principal investigator, Lancaster General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01773629
- Sponsor's protocol ID
- 2010-38-LGH
- Acronym
- CMPD
- Status last verified
- Jan 2014
- First submitted
- 16 Jan 2013
- Last updated
- 30 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Care Managers for Perinatal Depression (CMPD)
- ClinicalTrials.gov ID
- NCT01773629
- Acronym / sponsor ID
- CMPD / 2010-38-LGH
- Conditions
- Depression, Pregnancy
- Keywords
- Depression, Pregnancy, Postpartum, Perinatal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 194 participants (actual)
- Lead sponsor
- Lancaster General HospitalUniversity, hospital or other
- Collaborators
- University of Pennsylvania, Robert Wood Johnson Foundation
- Study start
- Sep 2010
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 23 Jan 2013 (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 investigators will evaluate effects of introducing the care manager on:
- Patient receipt of timely diagnosis and initiation of treatment for major depression (diagnosis within 2 weeks of screening and treatment within 1 month of diagnosis); and
- Patient continuity of care for depression across the transition of care from pregnancy to postpartum (within 4 months postpartum).
Detailed description
The first two specific research aims of this proposed randomized study will evaluate the benefits of introducing site specific care managers into established multi-component enhancements of perinatal depression care. The four study sites are members of the IMPLICIT perinatal quality improvement network and provide prenatal care to a diverse population of low income minority women using a common set of care processes within diverse practice models including Obstetric, Family Medicine, and Nurse Practitioner/Midwifery settings. The established processes of care include evidence based screening, diagnosis, treatment protocols and quality improvement care teams.
The investigators will evaluate effects of introducing the care manager on:
- Patient receipt of timely diagnosis and initiation of treatment for major depression (diagnosis within 2 weeks of screening and treatment within 1 month of diagnosis); and
- Patient continuity of care for depression across the transition of care from pregnancy to postpartum (within 4 months postpartum).
For the third and fourth specific research aims we will conduct supplementary econometric and qualitative analyses to aid in understanding the provider and system context in which this intervention is implemented across the four study sites. Results of this evaluation will be used to understand for whom and in which systems of care this model is most successful as well as the costs of delivering this intervention.
Specifically the investigators will:
- Employ econometric techniques to quantify the costs of implementing and maintaining the IMPLICIT collaborative care maternal depression intervention; and
- Develop institutional ethnographies of the four study sites and identify factors associated with relative success in implementing perinatal depression care managers and improving timely diagnosis, initiation, and continuity of depression care.
Achieving these aims will provide the foundation for dissemination of this innovative approach to perinatal depression care delivery throughout the entire growing IMPLICIT network which now extends across the northeast and mid-Atlantic regions of the US; sites which provide perinatal care for low income minority women in urban, rural, and suburban communities. These sites include prenatal practices in the Robert Wood Johnson Foundation Aligning Forces for Quality initiative, the Healthy York County Coalition which is partnering with us to disseminate this work in their region.
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: InterventionParticipants in the intervention arm will receive standard care plus the addition of a care manager. Care managers will function to provide culturally competent and linguistically appropriate support for the care of women identified as being at high risk for depression in pregnancy. Working with both the care providers and these study participants care managers will serve as connectors, coaches, collaborators, and negotiators working to overcome barriers to depression care delivery. |
| Control | Other | Other: ControlStandard of care: within the current care processes, a woman initiating prenatal care completes a depression risk assessment using a two-step approach. Women with high risk of depression are then scheduled for a separate visit with a member of the care team (a physician, psychologist, or other mental health provider) referred to as a "perinatal depression champion" for a timely formal diagnostic interview. |
Who may qualify
- Ages
- 13 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Female
- Current pregnancy or experienced pregnancy in the past 6 weeks
- Score >= 12 on PHQ9
Key exclusion criteria (3 listed)
- < age 13
- Mental illness
- Primary language other than English or Spanish
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 |
|---|---|---|
| InterventionParticipants in the intervention arm will receive standard care plus the addition of a care manager. Care managers will function to provide culturally competent and linguistically appropriate support for the care of women identified as being at high risk for depression in pregnancy. Working with both the care providers and these study participants care managers will serve as connectors, coaches, collaborators, and negotiators working to overcome barriers to depression care delivery. | Other | Intervention |
| ControlStandard of care: within the current care processes, a woman initiating prenatal care completes a depression risk assessment using a two-step approach. Women with high risk of depression are then scheduled for a separate visit with a member of the care team (a physician, psychologist, or other mental health provider) referred to as a "perinatal depression champion" for a timely formal diagnostic interview. | Other | Control |
Primary outcome
Diagnosis of major depression within 2 weeks of screening
Time frame: 2 weeks after screening
Patient receipt of timely diagnosis for major depression during perinatal period.
Treatment of major depression within 1 month of diagnosis
Time frame: 1 month
Patient receipt of timely initiation of treatment for major depression during the perinatal period.
Transition of care from pregnancy to postpartum
Time frame: 4 months
Patient continuity of care for depression across the transition of care from pregnancy to postpartum within 4 months postpartum.
2 secondary outcomes
Quantify the costs of implementing a care manager
Time frame: 3 years
Qualitative assessment of success in implementation of perinatal depression care management process.
Time frame: 3 years
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 30 Jan 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.
Stephen Ratcliffe, MD, MSPH principal investigator
Lancaster General Hospital
Ian M Bennett, MD, PhD principal investigator
University of Pennsylvania
Donna Cohen, MD, MS principal investigator
Lancaster General Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention in people with Depression and Pregnancy, run by Lancaster General Hospital at 4 sites 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 3 inclusion and 3 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 30 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
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?
Diagnosis of major depression within 2 weeks of screening (time frame: 2 weeks after screening). The study lists 3 primary outcomes in all. 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 30 Jan 2014.