Pediatric Integrative Medicine Trial Pilot (PIM)

Pilot Study of Pediatric Integrative Medicine in Pediatric Oncology, General Pediatrics and Pediatric Cardiology

This study will investigate if adding complementary therapies such as acupuncture, massage and reiki to inpatient pediatric care is feasible and what the effects are on outcomes such as patient symptoms, cost, safety, satisfaction and length of stay.

Study Overview

• Status: Completed
• Conditions: Pain; Nausea; Vomiting; Anxiety
• Intervention / Treatment: Procedure: Usual care; Procedure: PIM consult and service provision

Detailed Description

Study Objective: To determine if a pediatric integrative medicine (PIM) service is effective in reducing overall symptoms of pain, nausea/vomiting, and/or anxiety (PNVA), length of stay, and costs, in hospitalized children when compared to conventional care. In this context, "integrative" refers to a combined approach of complementary and conventional medical therapies in an evidence-based fashion.

Design: cluster trial; 2-arm controlled evaluation study in pediatric oncology, general pediatrics and pediatric cardiology. Intervention will be offered during a 6-month PIM period following a 6 month control period.

Population: Inclusion criteria: (i) In-patients in participating division and (ii) informed consent/assent. Exclusion criteria: (i) lack of parent participation, fluency in English, or informed consent

Intervention: Recommendations for specific CAM therapies will be determined by a staff PIM pediatrician. Any combination of the following CAM therapies (dose, duration, amount to be based on patient need as assessed by CAM provider, patient, and parent): acupuncture/acupressure, massage, Reiki; all are to be offered in addition to usual care.

Control: Usual care.

Outcomes: Primary outcome: feasibility (i.e enrollment); Secondary outcomes: (i) PNVA symptom management, (ii) need for conventional pharmacotherapy, (iii) adverse events; (iv) parent and health care provider satisfaction with care provided, v) length of stay; and vi) cost-effectiveness (analysis of this outcome to be limited to patients admitted for at least 2 days and for not more than 30 days).

Significance: To our knowledge, this study will be the first comparative effectiveness trial to assess the impact of PIM for hospitalized children with cancer.

• Study Type: Interventional
• Enrollment (Actual): 872
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G 2B7
      • Stollery Childrens' Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 16 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• (i) all children, aged 0-16 years, who are admitted to Pediatric Oncology, General Pediatrics and Pediatric Cardiology at the Stollery Children's Hospital, Edmonton, Canada who
• (ii) can communicate in English; and
• (iii) give informed consent/assent

Exclusion Criteria:

• (i) cannot communicate in English;
• (ii) lack of parent availability to participate; or
• iii) lack of informed consent.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Usual care; Usual care provided to pediatric inpatients	Procedure: Usual care; Usual care consists of all conventional care options in pediatric oncology including medication and other therapies.
Experimental: PIM consult and service provision; Pediatric integrative medicine service (PIM) through which pediatric inpatients will have the option of supplementing their usual care with acupuncture/acupressure, massage, and/or reiki	Procedure: Usual care; Usual care consists of all conventional care options in pediatric oncology including medication and other therapies.; Procedure: PIM consult and service provision; If service is requested, treatment options include acupuncture/acupressure, massage, and reiki

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Enrollment	Enrollment of study participants over length of study which will inform conduct of a larger study in this population	up to 5 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in pain	For pre-verbal children: Faces, Legs, Activity, Cry, Consolability tool Verbal children: faces Pain Scale-Revised	up to 5 days
Change in nausea/vomiting	Baxter Retching Faces scale	up to 5 days
Change in anxiety	Pediatrics Anxiety Faces scale	up to 5 days
Incidence of adverse events	BC Children's Hospital Patient Safety Questionnaire; Canadian Pediatric Trigger tool	up to 5 days
Parent satisfaction with patient care	Hospital's standardized satisfaction survey; State-Trait Anxiety Invenvtory	up to 5 days
Length of hospital stay		up to 5 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Resource Utilization/Cost	Resource utilization and related costs will be compared between study arms	Analysis of this outcome to be limited to patients admitted for at least 2 days and for not more than 30 days

Collaborators and Investigators

• Sponsor: University of Alberta
• Collaborators: Lotte & John Hecht Memorial Foundation

Study record dates

Study Major Dates

• Study Start: February 1, 2013
• Primary Completion (Actual): February 1, 2016
• Study Completion (Actual): September 1, 2016

Study Registration Dates

• First Submitted: December 16, 2013
• First Submitted That Met QC Criteria: January 6, 2014
• First Posted (Estimate): January 7, 2014

Study Record Updates

• Last Update Posted (Actual): May 8, 2017
• Last Update Submitted That Met QC Criteria: May 3, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: pain; oncology; pediatric; anxiety; cost-effectiveness; complementary and alternative medicine; nausea/vomiting
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Nausea; Vomiting
• Other Study ID Numbers: PIM1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED