Children With Medical Complexity (CMC), Decision Aids, Decision Support Systems, Clinical, Multiple Chronic Conditions, Neuromuscular Scoliosis, Shared Decision Making
Conditions
Keywords
children with medical complexity, shared decision making, values clarification, uncertainty communication, decision support tool
Brief summary
The goal of this pilot hybrid type I efficacy/implementation trial is to assess a newly developed decision support tool patients, parents, and providers to use during surgical treatment decision making for neuromuscular scoliosis (NMS). Results from this pilot will inform the design of a future larger effectiveness trial of the decision support tool. Participants will either receive usual care or receive the decision support tool. Researchers will assess the decision made, decision quality, individual affective, cognitive, and behavioral effects, and feasibility and acceptability of tool use. They will also collect potential barriers and facilitators to implementation and feedback about the tool and study design to maximize likelihood of successful deployment of the tool into clinical practice and inform the design of a future trial. The outcomes measures will be used to inform potential effect size estimates to inform a future trial.
Detailed description
Neuromuscular scoliosis (NMS) can result in severe disability for children. Non-operative management including bracing and physical therapy minimally slows scoliosis progression, but operative management with posterior spinal fusion (PSF) carries high risks of morbidity and mortality in part due to the multiple comorbid conditions seen in children with NMS. Decisions like PSF that have no clear best treatment option are best served by shared decision making (SDM). SDM is a collaborative process where patients, parents, and providers share their knowledge, preferences, and values to reach treatment plan agreement. Our prior qualitative study creating a framework of SDM for children with multiple comorbid conditions like children with NMS found that parents face immense decision related uncertainty that often goes unacknowledged by providers and that parents and providers struggle with identifying and communicating family preferences and values that are important for treatment decision making. Our prior work has identified optimal methods to communicate uncertainty and identified the preferences and values parents of children with NMS have when it comes to treatment decision making for NMS. This study will pilot test a decision support tool that contains these elements.
Interventions
BEHAVIORALDecision support tool
Decision support tool developed for patients, parents, and providers of children with neuromuscular scoliosis
Sponsors
University of Utah
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
pre-intervention crossed over to post-intervention design for provider participants
Eligibility
Sex/Gender
ALL
Age
8 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Parent-child dyads of children with neuromuscular scoliosis who speak English and Spanish. * Child is between ages 8-21 years of age and they are coming into the pediatric orthopaedic surgery clinic for consultation about potential surgery for NMS. * NMS is defined as having neurologic impairment (NI) and scoliosis using relevant ICD-9 or ICD-10 codes from Feudtner, et al. 2014 or Berry, et al. 2012. or a qualifying diagnosis per the Pediatric Spine Study Group definition of NMS. * All pediatric orthopaedic surgeons and neurosurgeons who treat neuromuscular scoliosis at our study sites will be eligible participants.
Exclusion criteria
* Families whose child with NMS is less than 8 years of age at time of orthopaedic consultation because surgery at a younger age usually indicates an atypical case. * Children with the diagnosis of Becker's muscular dystrophy due to potential disease modifying therapies that may alter curve progression.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intention for NMS treatment | Immediately after clinic visit | Parent degree of decision preference (1: no surgery-9: surgery) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intention for NMS treatment | Immediately after clinic visit | Parent's desired treatment option: Binary (1- surgery, 0- no surgery) |
| Intention for not delaying treatment | Immediately after clinic visit | For parents who select surgery, the intention of treatment timing. |
| Knowledge questions | Immediately after clinic visit | Parent's response to five decision-related knowledge questions, scored as total answered correctly |
| Acceptability of intervention | Immediately after clinic visit | Measured quantitatively by the validated Acceptability of Intervention Measure for caregivers in the intervention group. The scale consists of 4 items rated on a 5-point Likert scale. A mean score is created with a higher score indicating higher acceptability. |
| Physician trustworthiness | Immediately after clinic visit | The Dugan Physician Trust Scale is a validated 5-item survey measure to assess the participant's trust in their physician. Each item is rated on a 5-point Likert scale and one item is reverse coded before all items are summed to create a composite score. Higher scores indicate stronger trust in the physician. |
| Feasibility of intervention | Immediately after clinic visit | Measured by the validated Feasibility of Intervention Measure. The scale consists of 4 items rated on a 5-point Likert scale. A mean score is created with a higher score indicating higher acceptability. |
| Risk perception | Immediately after clinic visit | 2 unique items on perception of risk related to decision, scored individually. Each item is rated on a 5-point Likert scale. The items will be scored individually with higher responses indicating higher perceived decision-related risk. |
| Decision conflict | Immediately after clinic visit | Decisional conflict scale and 2 unique decision conflict items (individual items scored individually). Each item is rated on a 5-point Likert scale. The items will be scored individually with higher responses indicating higher decisional conflict. |
| Decision readiness | Immediately after clinic visit | Preparation for Decision Making (PrepDM): The PrepDM scale is a validated 10-item survey measure that evaluates the participant's perception of how helpful their clinic visit was in preparing them to make the decision. Each item is rated on a 5-point Likert scale, and scores are standardized to a 0-100 scale, with higher scores indicating greater perceived readiness for decision-making. |
| Acceptability of Intervention- Qualitative | Within 3 months of clinic visit (for parents) and at end of study, approximately within 18 months of consent (for providers). | Qualitatively assessed via focus groups and individual interviews for caregivers in intervention group and provider participants. |
| Worry | Immediately after clinic visit | Consists of 3 unique items to assess the participant's level of worry related to decision making. Each item is rated on a 5-point Likert scale. The items will be scored individually with higher responses indicating higher levels of decision-related worry. |
| Quality of shared decision making | Immediately after clinic visit | Quantitatively via the 9-item SDM-Q-9 (parent) and SDM-Q-Doc (provider) surveys. Each item is rated on a 6-point Likert scale. The total score is standardized to a scale from 0 to 100, with higher scores indicating greater perceived involvement in decision-making. |
| Decisional self-efficacy | Immediately after clinic visit | The Decisional Self-Efficacy Scale is a validated 11-item survey measure that evaluates the participant's ability to make informed health-related decisions. Items are rated on a 5-point Likert scale and scores are standardized to a 0-100 scale, with higher scores reflecting greater decisional self-efficacy. |
| preference concordance for parents | Immediately after clinic visit | Compare parent self-rated top three values/preferences driving decision making with decision they chose for consistency of decision with values/preferences. Will be scored based on number of values (out of 3) that match the treatment option selected. |
| Appropriateness of intervention | Immediately after clinic visit | Measured quantitatively by the validated Appropriateness of Intervention Measure. The scale consists of 4 items rated on a 5-point Likert scale. A mean score is created with a higher score indicating higher acceptability. |
| Preference concordance between parents and providers | Immediately after clinic visit | Correlation between top three parent preferences and values for decision identified by parents and by providers, calculated via a kappa score. |
| Feasibility of Intervention- Qualitative | Within 3 months of clinic visit (for parents) and at end of study, approximately within 18 months of consent (for providers). | Qualitatively assessed via focus groups and individual interviews for caregivers in intervention group and provider participants. |
| Appropriateness of Intervention- Qualitative | Within 3 months of clinic visit (for parents) and at end of study, approximately within 18 months of consent (for providers). | Qualitatively assessed via focus groups and individual interviews for caregivers in intervention group and provider participants. |
| Quality of shared decision making- qualitative | During clinic visit | Using the DEEP-SDM coding scheme on video- and audio-recorded clinical encounters |
Countries
United States
Contacts
CONTACTAngela Zhu, BS
CONTACTMichelle Wilcox
PRINCIPAL_INVESTIGATORJody Lin, MD, MS
University of Utah
Outcome results
None listed