Helping Patients With Spinal Stenosis Make a Treatment Decision: A Randomized Study Assessing The Benefits of Health Coaching (SST HCoach RCT)
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Purpose
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 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.
| Condition | Intervention |
|---|---|
|
Spinal Stenosis |
Behavioral: Post DA viewing coaching Other: Usual Care |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Health Services Research |
- Assess the impact of decision coaching, following a specialty consultation for lumbar spinal stenosis [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- 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.
| Estimated Enrollment: | 200 |
| Study Start Date: | November 2010 |
| Estimated Study Completion Date: | May 2013 |
| Estimated Primary Completion Date: | May 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Non-Coaching
Usual care for patients with a diagnosis of spinal stenosis after viewing a DA and completing a survey.
|
Other: Usual Care
Patient views DA and completes post DA survey.
|
|
Coaching
Patients randomized to coaching group will receive one week post viewing of Decisional Aid.
|
Behavioral: Post DA viewing coaching
Coaching
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- English Speaking
- Adults over 18
Exclusion Criteria:
- Non-English Speaking
- Anyone under the age of 18
- Prisoners
Contacts and Locations| United States, New Hampshire | |
| Dartmouth-Hitchcock Medical Center | |
| Lebanon, New Hampshire, United States, 03756 | |
| Principal Investigator: | Jon D Lurie, M.D. | Dartmouth-Hitchcock Medical Center |
More Information
No publications provided
| Responsible Party: | Dartmouth-Hitchcock Medical Center |
| ClinicalTrials.gov Identifier: | NCT01263678 History of Changes |
| Other Study ID Numbers: | 22508 |
| Study First Received: | December 17, 2010 |
| Last Updated: | July 16, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Dartmouth-Hitchcock Medical Center:
|
Decisional Conflict Coaching Decisional Regret |
Additional relevant MeSH terms:
|
Constriction, Pathologic Spinal Stenosis Pathological Conditions, Anatomical |
Spinal Diseases Bone Diseases Musculoskeletal Diseases |
ClinicalTrials.gov processed this record on May 19, 2013