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

Spinal Stenosis Clinical Trial

— SST HCoach RCT  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01263678
• Other study ID #: 22508
• Status: Completed
• Phase: N/A
• First received: December 17, 2010
• Last updated: August 1, 2013
• Start date: November 2010
• Est. completion date: May 2013

Study information

• Verified date: August 2013
• Source: Dartmouth-Hitchcock Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 199
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• English Speaking

• Adults over 18

Exclusion Criteria:

• Non-English Speaking

• Anyone under the age of 18

• Prisoners

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Spinal Stenosis

Intervention

Behavioral:
• Coaching
Decision support coaching will be provided after the participant has viewed the decision aid

Other:
• Usual Care
Patient views DA and completes post DA survey.

Locations

Country	Name	City	State
United States	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire

Sponsors (1)

Lead Sponsor	Collaborator
Dartmouth-Hitchcock Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No