PregnancyNCT00961987
Innovation to Providing Interprofessional Maternity Care
A study testing Collaborative model in people with Pregnancy, run by McMaster University at 1 site in Canada.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 16 to 60 years, women only
- Conditions the study is for
- Pregnancy
- What is being tested?
- Collaborative model
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 700 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2009to Jun 2010
- 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 16 to 60 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- 16 years of age or older
- Attending their intake appointment at the Centre
- Ability to understand English
- Legal status in Canada
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Pregnancy
- Being tested
- Collaborative model, Usual care
- Keywords
- Maternity care, Interprofessional collaboration, Continuity of Care, Integration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collaborative modelOther
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.
Usual careOther
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
| Study group | Role | What they receive |
|---|---|---|
| Collaborative model | Experimental | 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. Receives: Other: Collaborative model |
| Usual care | Active comparator | 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 Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient outcomes (birth outcomes)
Measured: 9 months
Secondary outcomes (2)
Patient satisfaction
Measured: 9 months
Healthcare utilization
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2009 (estimated)
- Study startOct 2009
- Primary completionJun 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Investigators
- Keyna Bracken, MD, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00961987
- Sponsor's protocol ID
- 05-1309
- Status last verified
- Aug 2009
- First submitted
- 18 Aug 2009
- Last updated
- 19 Aug 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Innovation to the Provision of Maternity Care in Hamilton: An Inter- and Intraprofessional Collaboration
- ClinicalTrials.gov ID
- NCT00961987
- Acronym / sponsor ID
- 05-1309
- Conditions
- Pregnancy
- Keywords
- Maternity care, Interprofessional collaboration, Continuity of Care, Integration
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Jun 2010 (estimated)
- First posted
- 19 Aug 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Collaborative model | Experimental | Other: Collaborative modelPatients 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. |
| Usual care | Active comparator | Other: Usual careAt 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 |
Who may qualify
- Ages
- 16 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 16 years of age or older
- Attending their intake appointment at the Centre
- Ability to understand English
- Legal status in Canada
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Collaborative modelPatients 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. | Other | Collaborative model |
| Usual careAt 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 | Other | Usual care |
Primary outcome
Patient outcomes (birth outcomes)
Time frame: 9 months
2 secondary outcomes
Patient satisfaction
Time frame: 9 months
Healthcare utilization
Time frame: 9 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2009.
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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.
Keyna Bracken, MD principal investigator
McMaster 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 Collaborative model in people with Pregnancy, run by McMaster University at 1 site in Canada.
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 4 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: status not confirmed, as of the sponsor's last update on 19 Aug 2009. 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 Canada. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christine Rodriguez, MSc (905-525-9140 ext. 27528, rodrigmc@mcmaster.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient outcomes (birth outcomes) (time frame: 9 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 19 Aug 2009.