Well Child CareNCT02382978
Feasibility Study of Nurse-Provided Well Child Care
A study testing nurse-provided well child visit in people with Well Child Care and Multidisciplinary Care, run by Ottawa Hospital Research Institute.
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. Read more about this study
- Who is it for?
- Ages 6 weeks to 4 yearsHealthy volunteers can take part
- Conditions the study is for
- Well Child Care, Multidisciplinary Care, Family Medicine
- What is being tested?
- nurse-provided well child visit
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Apr 2015to Jul 2016
- 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 6 weeks to 4 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- -
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Feasibility Study of Nurse-Provided Well Child Care in Family Health Team in Ontario, Canada
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.
Read the detailed 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.
- Conditions
- Well Child Care, Multidisciplinary Care, Family Medicine
- Being tested
- nurse-provided well child visit
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nurse-provided well child visitOther
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: nurse-provided well child visit |
What is being measured
The primary outcome is the main question the study is designed to answer.
nurse-provided well child care
qualitative data from interviews and focus groups about acceptability
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 posted9 Mar 2015 (estimated)
- Study startApr 2015
- Primary completionJan 2016 (estimated)
- Study completionJul 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Well Child CareStudies of the same condition, open and under way.
- More trials run by Ottawa Hospital Research InstituteThe 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Bruyère Health Research Institute., College of Family Physicians of Canada, University of Ottawa
- Responsible party
- Principal investigator, Jolanda Turley, Ottawa Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02382978
- Sponsor's protocol ID
- 20150037-01H
- Status last verified
- Mar 2015
- First submitted
- 20 Feb 2015
- Last updated
- 9 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of Nurse-Provided Well Child Care in Family Health Team in Ontario, Canada
- ClinicalTrials.gov ID
- NCT02382978
- Acronym / sponsor ID
- 20150037-01H
- Conditions
- Well Child Care, Multidisciplinary Care, Family Medicine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Collaborators
- Bruyère Health Research Institute., College of Family Physicians of Canada, University of Ottawa
- Study start
- Apr 2015
- Primary completion
- Jan 2016 (estimated)
- Study completion
- Jul 2016 (estimated)
- First posted
- 9 Mar 2015 (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.
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.
Detailed 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| nurse-provided well child care visit | Experimental | Other: nurse-provided well child visitthese children will be seen by a nurse only for their regular, pre-scheduled well child care visit |
Who may qualify
- Ages
- 6 weeks to 4 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| nurse-provided well child visit | Other | nurse-provided well child care visit |
Primary outcome
nurse-provided well child care
Time frame: 9 months
qualitative data from interviews and focus groups about acceptability
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2015.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing nurse-provided well child visit in people with Well Child Care and Multidisciplinary Care, run by Ottawa Hospital Research Institute.
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 6 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 9 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
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 Jolanda Turley, MD (613 230 7788 ext. 243, jturley@bruyere.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
nurse-provided well child care (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 9 Mar 2015.