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Helping Patients With Spinal Stenosis Make a Treatment Decision: A Randomized Study Assessing The Benefits of Health Coaching (SST HCoach RCT)

Primary Purpose

Spinal Stenosis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Coaching
Usual Care
Sponsored by
Dartmouth-Hitchcock Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Spinal Stenosis focused on measuring Decisional Conflict, Coaching, Decisional Regret

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • English Speaking
  • Adults over 18

Exclusion Criteria:

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

Sites / Locations

  • Dartmouth-Hitchcock Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Non-Coaching

Coaching

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
December 17, 2010
Last Updated
August 1, 2013
Sponsor
Dartmouth-Hitchcock Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01263678
Brief Title
Helping Patients With Spinal Stenosis Make a Treatment Decision: A Randomized Study Assessing The Benefits of Health Coaching
Acronym
SST HCoach RCT
Study Type
Interventional

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dartmouth-Hitchcock Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Stenosis
Keywords
Decisional Conflict, Coaching, Decisional Regret

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
199 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Non-Coaching
Arm Type
Other
Arm Description
Usual care for patients with a diagnosis of spinal stenosis after viewing a DA and completing a survey.
Arm Title
Coaching
Arm Type
Other
Arm Description
Patients randomized to coaching group will receive one week post viewing of Decisional Aid.
Intervention Type
Behavioral
Intervention Name(s)
Coaching
Intervention Description
Decision support coaching will be provided after the participant has viewed the decision aid
Intervention Type
Other
Intervention Name(s)
Usual Care
Intervention Description
Patient views DA and completes post DA survey.
Primary Outcome Measure Information:
Title
Assess the impact of decision coaching, following a specialty consultation for lumbar spinal stenosis
Description
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.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: English Speaking Adults over 18 Exclusion Criteria: Non-English Speaking Anyone under the age of 18 Prisoners
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jon D Lurie, M.D.
Organizational Affiliation
Dartmouth-Hitchcock Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dartmouth-Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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