Helping Patients With Spinal Stenosis Make a Treatment Decision: A Randomized Study Assessing The Benefits of Health Coaching

Study Overview
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Brief Summary
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Treatment options for lumbar spinal stenosis include surgical and non-surgical approaches. For most people, the decision depends on how bothered they are by their symptoms and how they feel about having surgery. Since individuals with the same clinical presentation may feel differently about their symptoms and how they view the benefits and harms of their options, there is no agreed upon besttreatment. It has been shown that, for preference-sensitive decisions like this one, decision aids (tools that pair balanced, evidence-based information regarding treatment options with values clarification) improve patients'knowledge and realistic expectations, lower decisional conflict, increase patient involvement in decision making, decrease the number of undecided, and increase agreement between values and choice.1 The Spine Center, in collaboration with the Center for Shared Decision Making (CSDM) at Dartmouth Hitchcock Medical Center (DHMC), has been providing patients with decision aids (DAs) for several years. Hypothesis: Patients identified as having low literacy and/or high decisional conflict after viewing a video decision aid will show greater resolution of their decisional conflict, higher decision self-efficacy and less decision regret if a coaching intervention is paired with a video decision aid. Decision support in the form of coaching develops patients'skills in preparing for a consultation and deliberating about their options.2 A study of women with abnormal uterine bleeding showed that pairing coaching with a DA helped patients clarify their values and preferences, reduced costs, and increased long term satisfaction.3 The investigators plan to assess the impact of coaching in patients with lumbar spinal stenosis who are referred to the CSDM for a video decision aid about their treatment options. The investigators are also interested to learn whether screening for low literacy and high decisional conflict can identify a subgroup of patients who are more likely to benefit from coaching.

Conditions
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Spinal Stenosis

Intervention / Treatment
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* Behavioral: Coaching
* Other: Usual Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: English Speaking Adults over 18 Exclusion Criteria: Non-English Speaking Anyone under the age of 18 Prisoners

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Non-Coaching<br>Usual care for patients with a diagnosis of spinal stenosis after viewing a DA and completing a survey. | Other: Usual Care<br>* Patient views DA and completes post DA survey.<br>|
| Other: Coaching<br>Patients randomized to coaching group will receive one week post viewing of Decisional Aid. | Behavioral: Coaching<br>* Decision support coaching will be provided after the participant has viewed the decision aid<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the impact of decision coaching, following a specialty consultation for lumbar spinal stenosis | Assess the impact of decision coaching, following a specialty consultation for lumbar spinal stenosis, on levels of decisional conflict. Assess the impact of decision coaching on decision self-efficacy, the number of treatment decision-related clinical contacts, treatment follow-through and decision regret. Determine whether we can develop a tool that will allow us to identify patients most likely to benefit from coaching and develop a process to provide coaching to patients who need help making treatment decisions. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Decisional Conflict, Coaching, Decisional Regret