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

NCT01263678 | Completed

• 1 other identifier: 22508
• Study Type: interventional
• Target: 199
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Stenosis

Keywords

Decisional Conflict; Coaching; Decisional Regret

Outcome Measures

Primary Outcomes (1)

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

  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.

  1 year

Study Arms (2)

Non-Coaching

OTHER

Usual care for patients with a diagnosis of spinal stenosis after viewing a DA and completing a survey.

Other: Usual Care

Coaching

OTHER

Patients randomized to coaching group will receive one week post viewing of Decisional Aid.

Behavioral: Coaching

Interventions

Coaching BEHAVIORAL

Decision support coaching will be provided after the participant has viewed the decision aid

Coaching

Usual Care OTHER

Patient views DA and completes post DA survey.

Non-Coaching

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• English Speaking
• Adults over 18

You may not qualify if:

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

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead

Study Sites (1)

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

MeSH Terms

Conditions

Spinal Stenosis

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Jon D Lurie, M.D.

  Dartmouth-Hitchcock Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2010
• First Posted: December 21, 2010
• Study Start: November 1, 2010
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: August 5, 2013

Record last verified: 2013-08

Locations

US (1)