NCT02382978

Brief Summary

This study will test whether or not nurses can provide well child care in a multi-disciplinary primary health care team without physicians also seeing the children at pre-scheduled well child care visits.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2015

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

February 20, 2015

Completed
17 days until next milestone

First Posted

Study publicly available on registry

March 9, 2015

Completed
23 days until next milestone

Study Start

First participant enrolled

April 1, 2015

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

March 9, 2015

Status Verified

March 1, 2015

Enrollment Period

9 months

First QC Date

February 20, 2015

Last Update Submit

March 6, 2015

Conditions

Outcome Measures

Primary Outcomes (1)

  • nurse-provided well child care

    qualitative data from interviews and focus groups about acceptability

    9 months

Study Arms (1)

nurse-provided well child care visit

EXPERIMENTAL

these children will be seen by a nurse only for their regular, pre-scheduled well child care visit

Other: nurse-provided well child visit

Interventions

nurse-provided well child care visit

Eligibility Criteria

Age6 Weeks - 4 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • born at term and from uncomplicated pregnancy and birth
  • normal physical growth and development to date
  • no parental post-partum depression
  • aged between 6 weeks and 4 years of age
  • due for WCC visits in the study period

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Jolanda Turley, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Staff Physician, Associate Professor, MD CCFP

Study Record Dates

First Submitted

February 20, 2015

First Posted

March 9, 2015

Study Start

April 1, 2015

Primary Completion

January 1, 2016

Study Completion

July 1, 2016

Last Updated

March 9, 2015

Record last verified: 2015-03