Information leaflets regarding diagnostic imaging for low back pain

INTERVENTION: This trial includes community participants and patient participants. Community participants will complete a survey (hosted by Qualtrics) on their computer. They will be asked to imagine that they have developed sudden, severe low back pain and have gone to their local emergency department. The scenario will state that before they have a consultation with the emergency department doctor, they pick‐up a leaflet in the waiting room. At this point, the randomiser function in Qualitrics survey will randomly allocate each community participant to view one of the three leaflets on their computer screen. The leaflets contain information about low back pain and use of imaging, presented in different ways (see below for more detail). No time limit will be given to participants to read the leaflet, however, they will not be able to navigate back to the leaflet once they begin answering the outcome questionnaires. Patient participants will also be given one of three leaflets to read but will base their answers on their own experience rather than receive the hypothetical scenario. After consenting to participate, a research assistant will give patient participants, who are waiting for their appointment at a back pain clinic, an iPad on which to read the leaflet. At this point, the randomiser function in Qualitrics survey will randomly allocate each patient participant to view one of the three leaflets on the iPad. The leaflets (identical to those provided to community participants) contain information about low back pain and use of imaging, presented in different ways (see below for more detail). No time limit will be given to participants to read the leaflet, however, they will not be able to navigate back to the leaflet once they begin answering the outcome questionnaires. Types of intervention leaflets: 1. Fact Box leaflet This leaflet contains "Fact Box" which contains balanced information on the benefits and harms of imaging for low back pain CONDITION: Low back pain; ; Low back pain Musculoskeletal ‐ Other muscular and skeletal disorders PRIMARY OUTCOME: The primary outcome will be the intention of participants to undergo diagnostic imaging for low back pain.; Participants will be asked: on a 10 point scale “Which describes your intention to have an imaging test to investigate your low back pain, (1=definitely will not, to 10=definitely will)."; ; [Immediately after exposure to the leaflet. ] SECONDARY OUTCOME: Additional open‐ended question in patient participants. ; ; "Did your intention to have/not have imaging change after viewing the leaflet? Why? Is there any other information you would like to know about imaging before making the decision?"[After reading the leaflet] Additional outcomes for patient participants ; ; Satisfaction with Decision scale ; ; "Regarding your intention to have diagnostic imaging for your low back pain, please rate how you feel about the following statements (1= strongly agree, 2= agree, 3= neither agree nor disagree, 4 disagree, 5= strongly disagree)?" ; [Immediately after patient participants rate their intention to have a scan.] Beliefs about the necessity of imaging for back pain‐��“Everyone who gets low back pain should have imagingâ€? from Back Beliefs Questionnaire (yes/no).[Immediately after exposure to the leaflet. In patient participants we will also assess intention to undergo diagnostic imaging for low back pain at 6 months and 12 months.] Decision regret scale ; ; ; 1. It was the right decision ; 2. I regret the choice that was made ; 3. I would go for the same choice if I had to do it over again ; 4. The choice did me a lot of harm ; 5. The decision was a wise one ; [At 6 months and 12 months with patient participants.] Harms ; "Regarding the decision you made about having/not having diagnostic imaging for your low back pain, please rate how you feel about the following statements ((1= strongly agree, 2= agree, 3= neither agree nor disagree, 4 disagree, 5= strongly disagree):" ; ; A potential harm of the intervention is an increase in illness‐related worry. We will collect information on illness‐related worry on a five point scale (0= no, 4= most of the time). ; ; 1. Do you worry about your health? ; 2. Are you worried you might get a serious illness in the future? ; 3. Does the thought of serious illness scare you? ; [Before reading the leaflet, after reading the leaflet, at 6 months and at 12 months.] Intention of patient participants to undergo diagnostic imaging for low back pain. ; Participants will be asked: on a 10 point scale “Which describes your intention to have an imaging test to investigate your low back pain, (1=definitely will not, to 10=definitely will)." ; ; [At 6 months and 12 months.] Knowledge (NB Although all participants will be asked these questions, some information will not have been covered by the Control leaflet. This will need to be considered when interpreting results e.g. only compare Knowledge results between the Fact Box leaflet vs the Nudge Leaflet). ; ; 1. Are people who undergo scanning more likely to feel better by 3 months than those who don’t? (Yes/No/Don't know) ; 2. Of 100 people with low back pain, about how many do you think benefit from having a back scan? ; 3. Of 100 people with low back pain, about how many do you think are harmed (eg, receive unnecessary surgery) by having a back scan? ; 4. Of 100 people with low back pain, about how many do you think get a false alarm (eg, ‘abnormal’ findings unrelated to the back pain) by having a back scan? ; [Before and after reading the leaflet] Other back pain related healthcare: ; ; 1. Number of visits to General Practitioner ; We will measure this by asking how many times did you visit General Practitioner in last 6/12 months for your back pain? (Open text) ; ; [At 6 months and 12 months] Other back pain related healthcare: ; ; 2. Number of visits to specialist ; We will measure this by asking how many times did you visit a specialist in last 6/12 months for your back pain? (Open text) ; [At 6 months and 12 months] Other back pain related healthcare: ; ; 3. Non‐pharmacological therapies used ; We will measure this by asking what types of non‐pharmacological therapies did you use for your back pain? (Open text) ; ; [At 6 months and 12 months] Other back pain related healthcare: ; ; 4. Medications used ; We will measure this by asking what medications did you use for your back pain? (Open text)[At 6 months and 12 months] Pain intensity numerical rating scale (NRS): ; Over the past week, how would you rate your pain intensity on 11‐point scale (0= no pain to 10= worst pain imaginable)? ; ; [Before patient participants read the leaflet, and again at 6 months and 12 months] Roland‐Morris disability questionnaire (RDQ) (each positive answer= 1 point; scale from 0= no disability to 24= severe disability)[Before patient participants read the leaflet, and again at 6 months and 12 months] Usefulness of the leaflet ; We will ask participants items from the Decisional Conflict Scale – Low Literacy Format, namely the ‘Informed’ and ‘Uncertainty’ subscales (yes, no, unsure)[Immediately after reading the leaflet] We will also ask patient participants following: ; ; Did you receive imaging (yes/no)? If yes, types of imaging received (X‐ray, CT or MRI). (Multi‐choice question) ; ; ; [At 6 months and 12 months follow up with patient participants.] Worry about low back pain ; 1. How reassured do you feel that there is no serious condition causing your back pain (0= not reassured at all to 10= completely reassured)? ; ; [Before reading the leaflet, after reading the leaflet, at 6 months and 12 months in patient participants.] Worry about low back pain ; 2. Do you think your symptoms should be investigated more extensively (laboratory tests, X‐rays etc. (yes/no)? [Before reading the leaflet, after reading the leaflet, at 6 months and 12 months in patient participants.] INCLUSION CRITERIA: Community participants: Community sample of people with or without a history of low back pain. Patient participants: Patients with low back pain before seeing clinicians at a back pain clinic attached to a teaching hospital in Sydney, Australia.