Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT02382978 |
| Other study ID # |
20150037-01H |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
February 20, 2015 |
| Last updated |
March 6, 2015 |
| Start date |
April 2015 |
| Est. completion date |
July 2016 |
Study information
| Verified date |
March 2015 |
| Source |
Ottawa Hospital Research Institute |
| Contact |
Jolanda Turley, MD |
| Phone |
613 230 7788 |
| Email |
jturley[@]bruyere.org |
| Is FDA regulated |
No |
| Health authority |
Canada: Institutional Review Board |
| Study type |
Interventional
|
Clinical Trial 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.
Description:
This study will deploy a mixed-methods convergent parallel design19, using quantitative
methods as well as qualitative data gathering and analyses. To test the acceptability and
satisfaction of the care received, interviews with patients and health care team members
will investigate attitudes and experiences of patients and care providers. To explore the
effectiveness and efficiency of nurse-led WCC, interviews and chart audits will assess the
quality of care provided, and costs in terms of time and team resources involved. These two
methods will occur simultaneously and the results will be integrated and reported together
to give an overall view of the feasibility of nurse-provided WCC within the Bruyere/Primrose
FHT.
Sample: There will be 2 cohorts of participants. The first cohort will consist of the health
care professionals involved, namely the family physicians and nurses from the
Bruyere/Primrose FHT who agree to participate and whose patients will be invited to join the
research study. The second cohort of participants will consist of parents of well children
who will be asked to have a nurse provide WCC during the pilot project. The eligibility
criteria will include:
- Most responsible provider agrees to appropriateness for inclusion
- 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 Recruitment: The appointment schedules and
panels of participating FHT physicians will be reviewed to identify eligible children
due or scheduled for a visit. The potential participants will be contacted by phone 1-4
weeks prior to their visit, by the research assistant, and have the project explained
to them with an invitation to participate or continue with their usual care. If a
parent agrees, verbal informed consent over the phone will be obtained. Consenting
patients will be offered the nurse intervention on arrival for their scheduled
appointment, with the option of seeing their family physician afterwards. They will
sign an informed consent form prior to the visit, which will also ask for interest in
participating in follow-up interviews.
Intervention: A proposed work-flow model for nurse-led WCC will be developed, informed by
both the literature review and competency-mapping exercise as well as with discussions with
the participating FHT physicians and nurses to ensure feasibility and buy-in. It is very
likely that the nurses will use the Rourke Baby Record, a standardized and validated
template for well child visits, endorsed for use by the College of Family Physicians of
Canada20, and used by many physicians at the Bruyere/Primrose clinics. FHT team members of
all disciplines will be asked to review the work-flow model during a consultation session to
provide feedback, buy-in, and validation. The plan will then be tested with a selected
cohort of infants and children and adjustments will be made according to feedback and
previously unanticipated issues. The pilot project will then commence and run for a 9-month
period to allow for multiple visits with the same patients, recall of patients requiring
specific WCC tasks and possibly alternating visits with the nurse and the family physician.
The goal is to perform 50 nurse WCC visits within the study period.
Data collection: To address our secondary research question, semi-structured interviews will
explore the acceptability of nurse-provided WCC for parents, nurses and physicians at the
Bruyere/Primrose FHT, focusing on potential facilitators and barriers to the introduction of
such a model of care. Interviews will be held with the provider cohort before and after the
intervention phase, and with patients after the nurse WCC visit. Interviews will stopped
when theme saturation is achieved or 10 providers and 20 patients have been interviewed,
which ever comes first. The interview guide will be developed by the research team using
information from the literature review, the competency mapping-exercise and the
consultations with the FHT members around recruitment and work-flow planning (see Appendix B
for potential interview questions). To further assess the acceptability and feasibility of
nurse led WCC, the investigators will compile initial participation rates (percentage of
patients contacted who accepted the nurse WCC) and continuation rates (percentage of
participants who were eligible for additional visits and who agree to at another nurse-led
WCC visit within the study period).
In order to provide quantitative data about the acceptability of nurse-provided WCC, the
electronic medical records of participants at the Bruyere/Primrose FHT will be searched for
quality indicators such as immunization rates, WCC visits attended by eligible patients, the
use of standard developmental questionnaires (eg. the Nippissing District Developmental
Screen), the completion of a template like the Rourke Baby Record, the proper documentation
of growth parameters, the frequency of visits during the study period, and appropriate
follow-up plans according to the WCC visit findings. Further or different indicators may be
selected, based on the competency-mapping exercise currently underway. Using the same data
extraction sheet developed for the participants' chart audit, similar data will be extracted
from a randomly selected age-matched cohort of control subjects not offered the intervention
and compared for the nine months before the intervention and during the 9 month study
period.
Analyses: The transcripts of the semi-structured interviews will be anonymized and then read
by several members of the research team, including the investigators. A coding template will
be developed based on the literature review and study objectives and may be iteratively
adapted during the initial interviews to allow for emerging themes. Thematic analysis will
be used to code the data, at first creating many codes, which will then be grouped and
collapsed into major themes and sub-themes21. At analysis meetings, the entire research team
will review the codes, themes and sub-themes to reach consensus about how the data answers
the question of feasibility and acceptability of nurse-provided WCC. To ensure rigour, these
themes will be compared to findings from the literature review and chart audit, triangulated
and then, final conclusions will be drawn22, 23, 24.
Quantitative data from the chart audit will be analyzed using SPSS 21 and descriptive
statistics will be generated to compare proportions receiving recommended care across the
two groups pre- and post-intervention. Our hypothesis is that there will be no difference in
the appropriate care manoeuvres received between the control group and the intervention
group. Patient characteristics will be summarized and reported by group. Discrete variables
will be summarized using frequencies and proportions. Comparisons of discrete variables
between groups will be made by using Chi-square or Fisher's exact test, as appropriate. As
this is a pilot project, the investigators do not expect to be powered to detect a
significant difference in care but these results will be used to triangulate the findings
from the qualitative data about appropriate care.
Participation rates will be calculated based on the proportion of invited patients who
participate in the intervention. Completion rates will be calculated to determine what
proportion of those who start with nurse-provided WCC continue with the intervention for all
of their visits during the full duration of the study.
Results: The quantitative and qualitative results will be integrated and reported together
to provide a description on the feasibility and acceptability, as well as the efficacy
compared to usual care of nurse-provided WCC.
