NCT00961987

Brief 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 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
700

participants targeted

Target at P75+ for not_applicable pregnancy

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 18, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 19, 2009

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2009

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Last Updated

August 19, 2009

Status Verified

August 1, 2009

Enrollment Period

8 months

First QC Date

August 18, 2009

Last Update Submit

August 18, 2009

Conditions

Keywords

Maternity careInterprofessional collaborationContinuity of CareIntegration

Outcome Measures

Primary Outcomes (1)

  • Patient outcomes (birth outcomes)

    9 months

Secondary Outcomes (2)

  • Patient satisfaction

    9 months

  • Healthcare utilization

    9 months

Study Arms (2)

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.

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

Other: Usual care

Interventions

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.

Collaborative model

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

Usual care

Eligibility Criteria

Age16 Years - 60 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • years of age or older
  • Attending their intake appointment at the Centre
  • Ability to understand English
  • Legal status in Canada

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maternity Centre

Hamilton, Ontario, L8P 4V1, Canada

Location

Study Officials

  • Keyna Bracken, MD

    McMaster University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Christine Rodriguez, MSc

CONTACT

Keyna Bracken, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 18, 2009

First Posted

August 19, 2009

Study Start

October 1, 2009

Primary Completion

June 1, 2010

Last Updated

August 19, 2009

Record last verified: 2009-08

Locations