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Clinical Trials/NCT01263678
NCT01263678
Completed
Not Applicable

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

Dartmouth-Hitchcock Medical Center1 site in 1 country199 target enrollmentNovember 2010
ConditionsSpinal Stenosis

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Spinal Stenosis
Sponsor
Dartmouth-Hitchcock Medical Center
Enrollment
199
Locations
1
Primary Endpoint
Assess the impact of decision coaching, following a specialty consultation for lumbar spinal stenosis
Status
Completed
Last Updated
12 years ago

Overview

Brief Summary

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 "best"treatment. 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.

Registry
clinicaltrials.gov
Start Date
November 2010
End Date
May 2013
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • English Speaking
  • Adults over 18

Exclusion Criteria

  • Non-English Speaking
  • Anyone under the age of 18
  • Prisoners

Outcomes

Primary Outcomes

Assess the impact of decision coaching, following a specialty consultation for lumbar spinal stenosis

Time Frame: 1 year

1. Assess the impact of decision coaching, following a specialty consultation for lumbar spinal stenosis, on levels of decisional conflict. 2. Assess the impact of decision coaching on decision self-efficacy, the number of treatment decision-related clinical contacts, treatment follow-through and decision regret. 3. 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.

Study Sites (1)

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