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

NCT03884387 | Completed

• 1 other identifier: 16/1586
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 1

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.

Conditions

Lumbar Herniated Disk

Keywords

Shared Decision Making, Lumbar Herniated Disk

Outcome Measures

Primary Outcomes (1)

• Decision Quality worksheet -for herniated disc (DQW-HD v.2.0)

  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.

  Meassured right after the surgeon-patient consultation

Secondary Outcomes (5)

• Decisional conflict scale

  Meassured right after the surgeon-patient consultation

• Visual Analog Scale (VAS) leg

  One month and one year after decision is made

• Decisional Regret Scale

  One month and one year after decision is made

• Oswestry Disability Index

  One year after the decision is made

• European Quality of life - 5 Dimensions (EQ-5D)

  One year after decision is made

Study Arms (2)

Use of a Patient Decision Aid

EXPERIMENTAL

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

Usual counceling

NO INTERVENTION

Usual counseling in the clinical encounter, when patients choose between surgical and non-surgical treatment for lumbar disc herniation .

Interventions

Patient Decision Aid OTHER

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.

Also known as: Beslutningshjælper©

Use of a Patient Decision Aid

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Spine Centre of Southern Denmark: lead
• University of Southern Denmark: collaborator

Study Sites (1)

Middelfart spine surgery research department

Middelfart, 5500, Denmark

Location

MeSH Terms

Conditions

Intervertebral Disc Displacement

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Stina B Andersen, MHS

  Sygehus Lillebaelt

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph.d. student

Study Record Dates

• First Submitted: January 3, 2019
• First Posted: March 21, 2019
• Study Start: May 22, 2017
• Primary Completion: April 13, 2019
• Study Completion: August 1, 2020
• Last Updated: July 23, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)