Management of Natural Health Products in Pediatrics
Management of Natural Health Products in Pediatrics
The project received expedited Institutional Review Board approval from Johns Hopkins University. Participant information was de-identified and data were secured on password-protected servers with access only to study investigators. Data will be destroyed 1 year after the project has been completed. An expert advisory board (comprised of physicians and PNPs with NHP expertise) was created to help monitor the progression of the project. Fidelity and adherence to the Institutional Review Board–approved plan was maintained throughout the implementation of the project.
An integrative review of the literature was conducted to determine how the evidence directs HCPs to manage NHPs (Gutierrez, Silbert-Flagg, & Vohra, 2014). Six key principles were synthesized: patient assessment, risk/benefit knowledge, patient resource knowledge, drug/herb interactions assessment/knowledge, clinical monitoring, and recognition of limitations and appropriate referral times (see Box). These principles were infused into the project plan and innovation.
The Pronovost framework was chosen to direct the translation of this project because of its strategic methodology for quality improvement project implementation and focus on patient safety. Key elements include summarizing the evidence, identifying local barriers to implementation, and measuring performances (Pronovost, Berenholtz, & Needham, 2008). The framework was adapted to focus on HCPs (rather than patients) to receive the intervention because NHP management is innately an HCP problem.
A paired pretest-posttest study design for quality improvement was used. The clinical intervention provided to the study group was an educational seminar and toolkit. The toolkit was developed and disseminated to assist PNPs in management of NHPs.
Two weeks prior to the educational seminar, a presurvey was distributed to collect baseline data. The survey, created with Qualtrics software, consisted of 25 questions. Completion of the survey served as consent for project participation. The survey collected participant demographic data, assessed for NHP PNP management practices, and contained an NHP knowledge test. The knowledge test consisted of 14 questions and measured knowledge of NHPs in the areas of patterns of use (four questions), drug/herb interactions (four questions), pharmacovigilance (four questions), and evidence-based resource knowledge (two questions).
One question on the presurvey determined PNP preference of NHP management tools. PNP preference for resources to support decision making with NHP management is reflected in Figure 1. Data from the presurvey guided materials included in the clinical toolkit.
(Enlarge Image)
Figure 1.
Pediatric nurse practitioner preference of tools for used for natural health product (NHP) management. Pediatric nurse practitioners preferred that all management tools be provided in the toolkit. This figure appears in color online at www.jpedhc.org.
Educational content provided in the seminar included information about NHP patterns of use, pharmacovigilance, U.S. regulations, and management resources. The toolkit consisted of resources to facilitate communication between patients and HCPs from the National Institute of Health's "Time to Talk" campaign, a one-page drug/herb interaction grid, scholarly materials for both patients and HCPs on the top 10 most commonly used NHPs, and a list of management resources that included trial memberships to two online management resources, Natural Standard and ConsumerLab.com (National Center for Complementary and Alternative Medicine, 2014, Cvijovic et al., 2009). The expert advisory group provided weekly feedback and was available for consultation as needed. Management practices were measured over an 8th-week study duration.
Power Analysis. HCPs consistently report a lack of knowledge to help guide decision making with NHPs (Cohen, Kemper, Stevens, Hashimoto, & Gilmour, 2005). A study in 2006 tested a group of more than 1200 health care interprofessionals on herb and dietary supplement comprehension and found a mean score of only 66% correct knowledge (Kemper, Gardiner, Gobble, & Woods, 2006). Using a standard deviation of 5 for a normal distribution (with a difference in mean of 20) for a paired t-test, the expected sample size is less than 10 (http://www.biomath.info/power/prt.htm; Snedecor & Cochran, 2014). Although there is no specific definition for a "small" sample size, statistical issues can arise when samples include fewer than 30 subjects (Fitzner & Heckinger, 2010). To achieve statistical power, the project sample size was determined a priori with a minimum of 30 participants. To account for a conservative rate of attrition between group one and group two of the sample (30%), enrollment of 39 PNPs was the recruitment aim.
Electronic data from the surveys were collected and stored on the secure and password-protected Qualtrics server. Data were cleaned and aggregated in two phases; presurvey and postsurvey data. PNPs who supplied the last four digits of their cellular phone numbers were then assigned a randomized number so that all data were de-identified. All data were imported into secured SPSS software for analysis.
Methods
Ethical Considerations
The project received expedited Institutional Review Board approval from Johns Hopkins University. Participant information was de-identified and data were secured on password-protected servers with access only to study investigators. Data will be destroyed 1 year after the project has been completed. An expert advisory board (comprised of physicians and PNPs with NHP expertise) was created to help monitor the progression of the project. Fidelity and adherence to the Institutional Review Board–approved plan was maintained throughout the implementation of the project.
Planning the Intervention
An integrative review of the literature was conducted to determine how the evidence directs HCPs to manage NHPs (Gutierrez, Silbert-Flagg, & Vohra, 2014). Six key principles were synthesized: patient assessment, risk/benefit knowledge, patient resource knowledge, drug/herb interactions assessment/knowledge, clinical monitoring, and recognition of limitations and appropriate referral times (see Box). These principles were infused into the project plan and innovation.
The Pronovost framework was chosen to direct the translation of this project because of its strategic methodology for quality improvement project implementation and focus on patient safety. Key elements include summarizing the evidence, identifying local barriers to implementation, and measuring performances (Pronovost, Berenholtz, & Needham, 2008). The framework was adapted to focus on HCPs (rather than patients) to receive the intervention because NHP management is innately an HCP problem.
Quality Improvement Intervention
A paired pretest-posttest study design for quality improvement was used. The clinical intervention provided to the study group was an educational seminar and toolkit. The toolkit was developed and disseminated to assist PNPs in management of NHPs.
Two weeks prior to the educational seminar, a presurvey was distributed to collect baseline data. The survey, created with Qualtrics software, consisted of 25 questions. Completion of the survey served as consent for project participation. The survey collected participant demographic data, assessed for NHP PNP management practices, and contained an NHP knowledge test. The knowledge test consisted of 14 questions and measured knowledge of NHPs in the areas of patterns of use (four questions), drug/herb interactions (four questions), pharmacovigilance (four questions), and evidence-based resource knowledge (two questions).
One question on the presurvey determined PNP preference of NHP management tools. PNP preference for resources to support decision making with NHP management is reflected in Figure 1. Data from the presurvey guided materials included in the clinical toolkit.
(Enlarge Image)
Figure 1.
Pediatric nurse practitioner preference of tools for used for natural health product (NHP) management. Pediatric nurse practitioners preferred that all management tools be provided in the toolkit. This figure appears in color online at www.jpedhc.org.
Educational content provided in the seminar included information about NHP patterns of use, pharmacovigilance, U.S. regulations, and management resources. The toolkit consisted of resources to facilitate communication between patients and HCPs from the National Institute of Health's "Time to Talk" campaign, a one-page drug/herb interaction grid, scholarly materials for both patients and HCPs on the top 10 most commonly used NHPs, and a list of management resources that included trial memberships to two online management resources, Natural Standard and ConsumerLab.com (National Center for Complementary and Alternative Medicine, 2014, Cvijovic et al., 2009). The expert advisory group provided weekly feedback and was available for consultation as needed. Management practices were measured over an 8th-week study duration.
Evaluation
Power Analysis. HCPs consistently report a lack of knowledge to help guide decision making with NHPs (Cohen, Kemper, Stevens, Hashimoto, & Gilmour, 2005). A study in 2006 tested a group of more than 1200 health care interprofessionals on herb and dietary supplement comprehension and found a mean score of only 66% correct knowledge (Kemper, Gardiner, Gobble, & Woods, 2006). Using a standard deviation of 5 for a normal distribution (with a difference in mean of 20) for a paired t-test, the expected sample size is less than 10 (http://www.biomath.info/power/prt.htm; Snedecor & Cochran, 2014). Although there is no specific definition for a "small" sample size, statistical issues can arise when samples include fewer than 30 subjects (Fitzner & Heckinger, 2010). To achieve statistical power, the project sample size was determined a priori with a minimum of 30 participants. To account for a conservative rate of attrition between group one and group two of the sample (30%), enrollment of 39 PNPs was the recruitment aim.
Electronic data from the surveys were collected and stored on the secure and password-protected Qualtrics server. Data were cleaned and aggregated in two phases; presurvey and postsurvey data. PNPs who supplied the last four digits of their cellular phone numbers were then assigned a randomized number so that all data were de-identified. All data were imported into secured SPSS software for analysis.
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