Comparative effectiveness of pediatric integrative medicine as an adjunct to usual care for pediatric inpatients of a North American tertiary care centre: A study protocol for a pragmatic cluster controlled trial

Abstract

BackgroundSome pediatric tertiary care centres in North America supplement conventional care with complementary therapies, together known as pediatric integrative medicine (PIM). Evidence to support the safety and efficacy of PIM is emerging, but the cost-effectiveness of an inpatient PIM service has yet to be assessed.Methods/DesignThis study is a pragmatic cluster controlled clinical trial. Usual care will be compared to usual care augmented with PIM in three pediatric divisions; oncology, general medicine, and cardiology at one large urban tertiary care Canadian Children's Hospital. The primary outcome of the feasibility study is enrolment; the primary outcome of the main study is cost-effectiveness. Other secondary outcomes include the prevalence and severity of key symptoms (i.e. pain, nausea/vomiting and anxiety), efficacy of PIM interventions, patient safety, and parent satisfaction.DiscussionThis trial will be the first to evaluate the comparative effectiveness, both clinical and cost, of a PIM inpatient service. The evidence from this study will be useful to families, clinicians and decision makers, and will describe the clinical and economic value of PIM services for pediatric patients admitted to hospital.

Pediatric Integrative Medicine in Academia: Stanford Children’s Experience

“…Large systematic reviews indicate potential cost-effectiveness and even cost savings for IM modalities in adult populations, though higher quality studies are needed [10]. Similar studies have not yet been published for pediatric patients but are currently underway [12].…”

Comparative Effectiveness of Pediatric Integrative Medicine: A Pragmatic Cluster-Controlled Trial

“…Study methods will be briefly discussed here; however, a full description of the study methods has been previously published [ 30 ].…”

Integrative Medicine: An Opportunity for Improving Quality of Care in the Inpatient Setting

“…The studies that have shown the promise of integrative therapies in the inpatient setting have included yoga, aromatherapy, meditation/relaxation, massage, acupuncture, and nutritional education as treatment modalities. [2][3][4][6][7][8][9][10][11][12][13][14] Despite suggested benefit, there is ambiguity regarding the optimal therapy or a combination of therapies for different clinical conditions, and it is also unclear which medical conditions respond the best to such therapies. An integral part of optimizing high-quality care for patients is knowing the therapies and doses that work for a population, and this cannot be determined with the existing body of literature.…”

“…CIM encompasses a wide variety of treatment modalities. The studies that have shown the promise of integrative therapies in the inpatient setting have included yoga, aromatherapy, meditation/relaxation, massage, acupuncture, and nutritional education as treatment modalities 2–4,6–14. Despite suggested benefit, there is ambiguity regarding the optimal therapy or a combination of therapies for different clinical conditions, and it is also unclear which medical conditions respond the best to such therapies.…”

“…There is a growing body of research demonstrating the benefits of integrative therapies in improving patient outcomes and health-related quality of life, often through reduction of pain and other symptoms that may otherwise be difficult to treat. 4,6,7 Complementary and integrative medicine (CIM) brings conventional and complementary approaches together in a coordinated way, with an emphasis on multimodal interventions, defined as 2 or more interventions such as conventional health care approaches (eg, medication, physical rehabilitation, psychotherapy) and complementary health approaches (eg, acupuncture, yoga, and natural products) in various combinations, with an emphasis on treating the whole person rather than one organ system or specific ailment. CIM aims for well-coordinated care among different providers and institutions by combining evidence-based conventional and complementary approaches.…”