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| ID | Type | Description | Link |
|---|---|---|---|
| 1K23AR079778 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual care | No Intervention | Participants receive usual care | |
| Decision support tool | Experimental | Participants receive the novel decision support tool |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Decision support tool | Behavioral | Decision support tool developed for patients, parents, and providers of children with neuromuscular scoliosis |
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| Measure | Description | Time Frame |
|---|---|---|
| Intention for NMS treatment | Parent degree of decision preference (1: no surgery-9: surgery) | Immediately after clinic visit |
| Measure | Description | Time Frame |
|---|---|---|
| Intention for NMS treatment | Parent's desired treatment option: Binary (1- surgery, 0- no surgery) | Immediately after clinic visit |
| Intention for not delaying treatment | For parents who select surgery, the intention of treatment timing. |
| Measure | Description | Time Frame |
|---|---|---|
| Barriers and facilitators to implementation | Qualitative analysis of interviews and focus groups from intervention group participants using the CFIR | Within 3 months of clinic visit (for parents) and at end of study, approximately within 18 months of consent (for providers). |
| Quality of interpretation |
Inclusion criteria:
Exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Angela Zhu, BS | Contact | 801-662-3675 | angela.zhu@hsc.utah.edu | |
| Michelle Wilcox | Contact | 801-581-6410 | michelle.o.wilcox@hsc.utah.edu |
| Name | Affiliation | Role |
|---|---|---|
| Jody Lin, MD, MS | University of Utah | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital Los Angeles | Recruiting | Los Angeles | California | 90027 | United States |
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pre-intervention crossed over to post-intervention design for provider participants
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| Immediately after clinic visit |
| Knowledge questions | Parent's response to five decision-related knowledge questions, scored as total answered correctly | Immediately after clinic visit |
| Acceptability of intervention | 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. | Immediately after clinic visit |
| Physician trustworthiness | 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. | Immediately after clinic visit |
| Feasibility of intervention | 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. | Immediately after clinic visit |
| Risk perception | 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. | Immediately after clinic visit |
| Decision conflict | 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. | Immediately after clinic visit |
| Decision readiness | 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. | Immediately after clinic visit |
| Acceptability of Intervention- Qualitative | Qualitatively assessed via focus groups and individual interviews for caregivers in intervention group and provider participants. | Within 3 months of clinic visit (for parents) and at end of study, approximately within 18 months of consent (for providers). |
| Worry | 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. | Immediately after clinic visit |
| Quality of shared decision making | 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. | Immediately after clinic visit |
| Decisional self-efficacy | 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. | Immediately after clinic visit |
| preference concordance for parents | 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. | Immediately after clinic visit |
| Appropriateness of intervention | 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. | Immediately after clinic visit |
| Preference concordance between parents and providers | Correlation between top three parent preferences and values for decision identified by parents and by providers, calculated via a kappa score. | Immediately after clinic visit |
| Feasibility of Intervention- Qualitative | Qualitatively assessed via focus groups and individual interviews for caregivers in intervention group and provider participants. | Within 3 months of clinic visit (for parents) and at end of study, approximately within 18 months of consent (for providers). |
| Appropriateness of Intervention- Qualitative | Qualitatively assessed via focus groups and individual interviews for caregivers in intervention group and provider participants. | Within 3 months of clinic visit (for parents) and at end of study, approximately within 18 months of consent (for providers). |
| Quality of shared decision making- qualitative | Using the DEEP-SDM coding scheme on video- and audio-recorded clinical encounters | During clinic visit |
5-item survey questions based on Napoles 2015 and qualitative analysis of recorded clinic visits to assess quality of interpretation. The first item assesses the type and need for interpretation, with participants selecting from 7 categories. If an interpreter was used, participants will then answer 4 additional items about the quality of interpretation for the visit. Each of these subsequent items is rated on a 5-point Likert scale (1-poor to 5-excellent). A mean composite outcome of the completed items is used to calculate overall quality. |
| immediately after clinic visit |
| Usability of intervention | System Usability Scale (SUS): The SUS is a validated 10-item survey measure that evaluates the perceived usability of the intervention. Items are rated on a 5-point Likert scale and scores are calculated by converting responses to a 0-100 scale, with higher scores indicating better usability. Only parent participants assigned to the intervention group will answer this measure. | Immediately after clinic visit |
| Mental load of intervention | NASA Task Load Index (NASA-TLX): The NASA-TLX is a validated measure used to assess the perceived mental workload of using the intervention. It consists of 6-items to measure 6 core dimensions: mental demand, physical demand, temporal demand, performance, effort, and frustration. Each dimension is rated on a scale from 0 to 100, and scores are combined to produce an overall workload score. Higher scores indicate greater perceived workload. Only parent participants assigned to the intervention group will answer this measure. | Immediately after clinic visit |
| Tool use | Metadata on tool interaction, inputs, and use | End of study, approximately 18 months after first enrollment. |
| Severe pneumonia | Chart review of medical records to count number of admissions for pneumonia. | Within 18 months of clinic visit |
| Readability | Consists of 2 unique items to assess how clearly the intervention is presented. Each item is rated on a 5-point Likert scale. The items will be scored individually. Only parent participants assigned to the intervention group will answer these items. | Immediately after the clinic visit |
| provider preferences and values for decision making | provider free response of top three reasons for decisiion that was made | immediately after clinic visit |
| parent preferences and values | selection of top three parent preferences and values for decision making from a list of options including a free response "other" field; asked to parent/patient participants and provider participants | immediately after visit |
| Quality of interpretation | Qualitative analysis of quality of interpretation captured on video-recordings of clinic visits. | During clinic visit |
| Decision adherence | Chart review of medical records to assess adherence to decision made. | Within 18 months after clinic visit. |
| Pain symptoms | Chart review of patient record for changes in pain symptoms related to scoliosis. Options include: worsened, unchanged, improved, not mentioned. | Within 18 months of clinic visit |
| Surgical outcomes | Chart review of medical records to assess for presence surgical outcomes: minor complications, major complications. | Within 18 months of clinic visit |
| Sitting comfort | Chart review of patient record for changes in sitting comfort symptoms related to scoliosis. Options include: worsened, unchanged, improved, not mentioned. | Within 18 months of clinic visit |
| ICU length of stay | For those who undergo surgery, the days the patient spent in the ICU after surgery | Within 18 months of clinic visit |
| Total length of stay | For those who undergo surgery, the days the patient spent in the the hospital after surgery | Within 18 months of clinic visit |
| Length of ventilation | For those who undergo surgery, the days the patient spent on mechanical ventilation (if not ventilated at baseline) or days spent on higher than normal mechanical ventilation settings (if ventilated at baseline). | Within 18 months of clinic visit |
| Pneumonia hospital days | Chart review of medical records to count number of days admitted for pneumonia. | Within 18 months of clinic visit |
| University of Utah | Recruiting | Salt Lake City | Utah | 84114 | United States |
|
| ID | Term |
|---|---|
| D000071069 | Multiple Chronic Conditions |
| ID | Term |
|---|---|
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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