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The Use of a Patient Decision Aid in the Choice of Surgery for Herniated Disc

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03884387
Recruitment Status : Active, not recruiting
First Posted : March 21, 2019
Last Update Posted : April 2, 2019
Sponsor:
Collaborator:
University of Southern Denmark
Information provided by (Responsible Party):
Stina Lykke Brogård Andersen, Spine Centre of Southern Denmark

Brief Summary:
Even though surgery due to lumbar disc herniation (LDH) shows a more rapid relief of pain and recovery, the evidence of surgery being superior to conservative treatment in the long term is inconclusive. Involving patients in the decisions whether or not to have surgery is therefore essential. A small survey performed at our Spine Center however, showed that patients were often not fully involved in this treatment decision. Not being involved might lead patients to decision regret and unnecessary conflicts in the decision-making process. The purpose of this project is therefore to assess the effect of a newly developed patient decision aid (PtDA) to facilitate shared decision making (SDM), when patients choose between surgical or non-surgical treatment for LDH, on SDM, decisional conflict, decision regret and treatment outcomes in a randomized controlled trial. The project is performed at Center of Spine Surgery & Research, Middelfart. Inclusion and one month follow up is already completed and one year follow-up data currently being collected.

Condition or disease Intervention/treatment Phase
Lumbar Herniated Disk Other: Patient Decision Aid Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 142 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Other
Official Title: The Use of a Decision Aid in the Choice of Surgery for Herniated Disc
Actual Study Start Date : May 22, 2017
Actual Primary Completion Date : April 13, 2018
Estimated Study Completion Date : August 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Herniated Disk

Arm Intervention/treatment
Experimental: Use of a Patient Decision Aid
A Patient Decision Aid is used in this arm in the clinical encounter. A tool designed to facilitate shared decision making when patients choose between surgical and non-surgical treatment for lumbar disc herniation .
Other: Patient Decision Aid
The Patient Decision aid used in this project is a tool designed to facilitate shared decision making in patients with lumbar herniated disk. It is intended to complement counseling with health professionals and help patients become involved in decision making by making explicit the decision that needs to be made, providing information about the advantages and disadvantages of having or not having surgery, knowledge of treatment outcomes, and by clarifying personal values.
Other Name: Beslutningshjælper©

No Intervention: Usual counceling
Usual counseling in the clinical encounter, when patients choose between surgical and non-surgical treatment for lumbar disc herniation .



Primary Outcome Measures :
  1. Decision Quality worksheet -for herniated disc (DQW-HD v.2.0) [ Time Frame: Meassured right after the surgeon-patient consultation ]

    Decision quality is defined as the extent to which treatments reflect the considered preferences of wellinformed patients and how well it is implemented. Decision quality worksheet - HD include decision-specific items to assess:

    1. knowledge, or the extent to which patients are informed
    2. patients' goals, concerns and preferred treatment. These items can then be used to calculate concordance, or the extent to which patients' receive treatments that match their goals.
    3. the decision making process, or the extent to which providers engage patients in decisions about their care.

    The three aspects are reported on separately, as a total knowledge score, a concordance (or in some cases dissonance) score, and a decisions process score.

    In this study only the knowledge and the process score is used. A total score is summed for each of the aspects ranging from 0-100 % with higher scores indicating a higher knowledge or a more shared decision- making process respectively.



Secondary Outcome Measures :
  1. Decisional conflict scale [ Time Frame: Meassured right after the surgeon-patient consultation ]

    The decisional conflict scale (DCS) measures personal perceptions of:

    1. uncertainty in choosing options;
    2. modifiable factors contributing to uncertainty such as feeling uninformed, unclear about personal values and unsupported in decision making; and
    3. effective decision making such as feeling the choice is informed, values-based, likely to be implemented and expressing satisfaction with the choice.

    A total score is presented ranging from 0-100 with 0 indicating no decisional conflict and 100 extremely high decisional conflict.


  2. Visual Analog Scale (VAS) leg [ Time Frame: One month and one year after decision is made ]
    The Visual Analogue Scale (VAS) consists of a straight line (10 cm of length) with the endpoints defining the limits 'no pain at all' to the left and 'pain as bad as it could be' to the right. The patient is asked to mark his pain level on the line between the two endpoints. The distance between 'no pain at all' and the mark then defines the patient's pain. A score is given ranging from 0-100 mm. A higher score indicates greater pain intensity.

  3. Decisional Regret Scale [ Time Frame: One month and one year after decision is made ]
    The Decision Regret Scale (a 5-item scale) measures "distress or remorse after a [health care] decision. A total score is presented ranging from 0-100 with 0 indicating no regret and 100 means high regret.

  4. Oswestry Disability Index [ Time Frame: One year after the decision is made ]
    This questionnaire has been designed to give information as to how patients back or leg pain is affecting their ability to manage in everyday life. The test is considered the 'gold standard' of low back functional outcome tools. A total score is presented ranging from 0-100 with 0 indicating no regret and 100 means high regret.

  5. European Quality of life - 5 Dimensions (EQ-5D) [ Time Frame: One year after decision is made ]
    EQ-5D is a standardized/generic measure of health status. It consists of 5 dimensions. Each of the dimensions are divided into 5 levels of perceived problems. A health state is defined by combining 1 level from each of the 5 dimensions. Each state is referred to in terms of a 5 digit code. In this study an idex value is found using the UK EQ-5D-5L index, which can define 3125 (=55) different health states. The value lies between -0.624 - 1.0, with higher index indicating better health state/quality of life and vice versa. (0.0 indicates death and -0,293 is beeing unconscious).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients seen by a surgeon in the Center for spine surgery and research, SLB.
  • Clinical symptoms and concordant MRI findings of a LDH from L1 to S1 with possible indication for primary discectomy surgery, assessed by an experienced spinal surgeon
  • Age >18
  • Able to understand and read Danish
  • Informed consent

Exclusion Criteria:

  • General contra-indication for spine surgery
  • Diagnosis of psychiatric disorder
  • Manifest paresis disorder
  • Previous spine surgery

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03884387


Locations
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Denmark
Middelfart spine surgery research department
Middelfart, Denmark, 5500
Sponsors and Collaborators
Spine Centre of Southern Denmark
University of Southern Denmark
Investigators
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Principal Investigator: Stina B Andersen, MHS Sygehus Lillebaelt
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Responsible Party: Stina Lykke Brogård Andersen, Ph.d. student, Spine Centre of Southern Denmark
ClinicalTrials.gov Identifier: NCT03884387    
Other Study ID Numbers: 16/1586
First Posted: March 21, 2019    Key Record Dates
Last Update Posted: April 2, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No IPD are to be shared with other researchers

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Stina Lykke Brogård Andersen, Spine Centre of Southern Denmark:
Shared Decision Making, Lumbar Herniated Disk
Additional relevant MeSH terms:
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Intervertebral Disc Displacement
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Hernia
Pathological Conditions, Anatomical