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NCT01263678 · ClinicalTrials.gov registry record · NA
Helping Patients With Spinal Stenosis Make a Treatment Decision: A Randomized Study Assessing The Benefits of Health Coaching
A NA study, sponsored by Dartmouth-Hitchcock Medical Center.
- Completed
- Registry status
- NA
- Development phase
- 199
- Enrollment target
NCT01263678 is a NA study that has completed, run by Dartmouth-Hitchcock Medical Center. The registered enrollment target is 199 participants.
The verdict
NCT01263678, a NA study, has completed, sponsored by Dartmouth-Hitchcock Medical Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 199 participants
- Enrollment target
Study 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 mor
Interventions
- OTHER Usual Care
- BEHAVIORAL Coaching
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 199 participants |
| Start Date | 2010-11 |
| Est. Completion | 2013-05 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01263678
The ClinicalTrials.gov registry entry for NCT01263678 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 199 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Dartmouth-Hitchcock Medical Center, which has 427 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Usual Care is the first listed.
NCT01263678 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01263678 about?
NCT01263678 is a clinical study titled "Helping Patients With Spinal Stenosis Make a Treatment Decision: A Randomized Study Assessing The Benefits of Health Coaching". 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 s...
What is the current status of trial NCT01263678?
This trial is currently completed. It is a NA study. The enrollment target is 199 participants. The study started on 2010-11. Estimated completion is 2013-05.
What interventions are being tested in trial NCT01263678?
The interventions under investigation include: Usual Care (OTHER), Coaching (BEHAVIORAL).
Who is sponsoring clinical trial NCT01263678?
This trial is sponsored by Dartmouth-Hitchcock Medical Center, which has 427 total clinical trials registered on ClinicalTrials.gov.
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