- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00961987
Innovation to Providing Interprofessional Maternity Care
August 18, 2009 updated by: McMaster University
Innovation to the Provision of Maternity Care in Hamilton: An Inter- and Intraprofessional Collaboration
The aim of this pilot project is to determine if there are differences in patient outcomes and healthcare utilization between patients randomly assigned to usual care (a collaborative model of maternity care with co-located healthcare professionals but with referrals to off-site obstetricians) or to a collaborative model of maternity care with co-located healthcare professionals, including obstetricians.
It is hypothesized that by creating a seamless interface between obstetrical consultation and ongoing longitudinal maternity care, patient outcomes (birth outcome data), patient satisfaction and healthcare utilization, including number of outpatient visits, ultrasounds, laboratory tests, consultations, etc, will be improved in the intervention group compared with the group receiving usual care.
The results could potentially lead to other sites adopting this innovative model of maternity healthcare delivery.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
700
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Christine Rodriguez, MSc
- Phone Number: 27528 905-525-9140
- Email: rodrigmc@mcmaster.ca
Study Contact Backup
- Name: Keyna Bracken, MD
- Phone Number: 905-528-5553
- Email: bracken@mcmaster.ca
Study Locations
-
-
Ontario
-
Hamilton, Ontario, Canada, L8P 4V1
- Maternity Centre
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 60 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- 16 years of age or older
- Attending their intake appointment at the Centre
- Ability to understand English
- Legal status in Canada
Exclusion Criteria:
-
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Collaborative model
Patients will be referred (if necessary) to an obstetrician who will be co-located in the Maternity Centre and who will be part of the collaborative model of maternity care.
|
Patients will be referred (if necessary) to an obstetrician who will be co-located in the Maternity Centre and who will be part of the collaborative model of maternity care.
|
Active Comparator: Usual care
At present, if Maternity Centre patients require the specialized services of an obstetrician, the current standard of care is to refer them to obstetricians located offsite with no professional ties to the Maternity Centre
|
At present, if Maternity Centre patients require the specialized services of an obstetrician, the current standard of care is to refer them to obstetricians located offsite with no professional ties to the Maternity Centre
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Patient outcomes (birth outcomes)
Time Frame: 9 months
|
9 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Healthcare utilization
Time Frame: 9 months
|
9 months
|
Patient satisfaction
Time Frame: 9 months
|
9 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Keyna Bracken, MD, McMaster University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2009
Primary Completion (Anticipated)
June 1, 2010
Study Registration Dates
First Submitted
August 18, 2009
First Submitted That Met QC Criteria
August 18, 2009
First Posted (Estimate)
August 19, 2009
Study Record Updates
Last Update Posted (Estimate)
August 19, 2009
Last Update Submitted That Met QC Criteria
August 18, 2009
Last Verified
August 1, 2009
More Information
Terms related to this study
Other Study ID Numbers
- 05-1309
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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