Clinical trial NCT03884387: The Use of a Patient Decision Aid in the Choice of Surgery for Herniated Disc
Official title: The Use of a Decision Aid in the Choice of Surgery for Herniated Disc
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lumbar Herniated Disk
Keywords: Shared Decision Making, Lumbar Herniated Disk
Lead sponsor: Spine Centre of Southern Denmark
Sponsor class: OTHER
Collaborators: name: University of Southern Denmark
First posted: 2019-03-21
Enrollment: 142
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Detailed description: Purpose of the project

The overall purpose of this study is to assess the effectiveness of a generic PtDA-template adapted to patients choosing between surgical and non-surgical treatment for LDH, on SDM, decisional conflict, decision regret and treatment outcomes in a randomized controlled trial. Development of an effective PtDA has the potential to decrease patients' decision regret and optimize treatment results and thereby in the future lead to higher patient satisfaction and fewer patient complaints. Using a generic PtDA-template, makes it feasible to adapt the used method to other spine-departments or other orthopedic-surgeries.

Background

Shared decision making (SDM) is a systematic approach aimed at improving patient involvement in preference-sensitive health care decisions. It is a process, wherein clinicians actively involve patients during the task of making decisions , based on best clinical evidence and patients' informed preferences.

Most people with lumbar disc herniation (LDH) improve with nonsurgical treatment. However, in Denmark, patients with ongoing severe pain and disability after 12 weeks of conservative care are recommended a surgical evaluation. Apart from the presence of a neurologic deficit, there are no clearly defined indications for surgery. A variety of factors, such as level of pain, walking capacity or functional limitations, can influence the judgment of the physician to advocate surgery or not. Indications for surgery are thus assessed, for each particular patient, by the individual surgeon. Even though surgical patients show a more rapid relief of pain and recovery, the evidence of surgery being superior to conservative treatment in the long term is nevertheless inconclusive. This underlines the concept that the choice of having surgical or non-surgical treatment for LHD is preference sensitive, meaning that treatment options should be offered and should matter to patients. A qualitative study by Andersen showed that the current lack of evidence for a superior treatment choice and the presence of uncertainties in risks and benefits are important to discuss with patients with LDH. Currently, there are no standard procedures used to actively involve patients in such decisions. SDM is required to accomplish the preference sensitive approach for patients with LDH.

Patient decision aids (PtDA) are tools designed to facilitate SDM, and are intended to complement counseling with health professionals. Such a tool could 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 treatment options (or tests), knowledge of treatment outcomes, and by clarifying personal values. Decision Aids compared to usual care seems to improve decision quality and patient knowledge regarding options and reduce their decisional conflict. Some studies also show that PtDAs enable patients to be more actively involved in decision making, and improve the accuracy of risk perceptions when probabilities are included A few English tools have already been designed for patients with LDH. However, these tools were designed to prepare the patients, prior to consultation with a physician and not, as intended in this project, to be used in the clinical encounter. Therefore, prior to this study a PtDAs have been designed and tested for use in spine surgery in a Danish context.

Study 1 - Does the use of a decision aid in a spine surgery clinic facilitate SDM?

Objectives

The Objectives are to determine whether the use of a DA is superior to standard consultation, in terms of:

1. Involving and informing the patients in the decision of treatment.
2. Minimizing uncertainty, and other conflicting factors, when choosing treatment for herniated disc.

Methods

Design The study will be performed as a randomized controlled trial (RCT). Ten surgeons will be allocated to either using or not using a DA in the surgery clinic, in a 1:1 ratio.

Intervention The intervention is the use of a PtDA for LDH, in a routine doctor-patient consultation, by a trained spine surgeon. All surgeons randomized to use the PtDA will go through a training session held by educators in communication, who is specialized in SDM.

Study population Study subjects will be recruited from Center for Spine Surgery and Research, Lillebaelt Hospital, Middelfart, amongst patients being a candidate for primary discectomy for a LDH from L1-S1.

Data will be collected post consultation in both arms, as the patients exit the consultation.

Statistics (see study 2)

Study 2 - Does the use of a decision aid in a spine surgery clinic improve outcomes?

Objectives

The objectives are to determine if there is a correlation between the use of a DA in the consultation and:

1. Better recovery after treatment, measured by leg pain (VAS leg), back pain (VAS back), ODI and EQ5D, one month and one year after spine surgery.
2. The level of decisional regret one month and one year after chosen treatment.

Methods

Design, intervention and study-population will be the same as in study 2. However, if patients end up with other surgery than discectomy they will be excluded from the study.

Statistical analysis

As the DQW-HD, DCS, ODI, EQ-5D and VAS Leg and Back pain scores are long ordinal scales, differences in scores, between the groups will be tested using nonparametric Mann-Whitney test for independent samples. Sample size rationale was powered from the main outcome variable in study 3 VAS-leg. Allowing for 30% dropout before completing the study, we need to enroll 70 patients in each arm. All Statistical analyses will be performed using Stata v. 14.0.

Research plan The inclusion started in May 2017. All the patients in the RCT are included and one month follow-up data are collected. Collection of one year follow-up data will has also begun.

Practical framework

All Spine surgeons at the surgery department accepted to participate in the study. Patients were recruited by these surgeons. The research department assists with data-collection at one month and one year follow-up.

Publication and dissemination of results

Results will be published in national and international peer-reviewed journals (i.e. The Spine, The Patient - Patient-Centered Outcomes Research) and presented at national and international conferences (i.e. Dansk Ortopædkirurgisk Selskabs årsmøde (DOS), International Shared Decision Making conference (ISDM), International Conference on Communication in Health Care (ICCH).

Ethical aspects

The study will be conducted according to Danish ethical principles, and notified at the Danish Data Protection Agency. Participants will be given written information about the purpose of the study and will sign an informed consent before the first questionnaires are completed. Surgeons give oral consent. Apart from the use of a PtDA in the consultation, all patients in the study receive "usual care". No changes are made in relation to which clinicians the patients meet or offered treatment.

Eligibility 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

Primary outcomes:
measure: Decision Quality worksheet -for herniated disc (DQW-HD v.2.0)
timeFrame: Meassured right after the surgeon-patient consultation
Secondary outcomes:
measure: Decisional conflict scale
timeFrame: Meassured right after the surgeon-patient consultation
measure: Visual Analog Scale (VAS) leg
timeFrame: One month and one year after decision is made
measure: Decisional Regret Scale
timeFrame: One month and one year after decision is made
measure: Oswestry Disability Index
timeFrame: One year after the decision is made
measure: European Quality of life - 5 Dimensions (EQ-5D)
timeFrame: One year after decision is made
Other outcomes:
Locations:
city: Middelfart
country: Denmark
facility: Middelfart spine surgery research department
Study officials:
affiliation: Sygehus Lillebaelt
name: Stina B Andersen, MHS
role: PRINCIPAL_INVESTIGATOR
References: