One-Page Patient Fact Sheets for Low Back Pain in Primary Care: A Randomized Clinical Trial

Abstract

Importance: Supporting informed decision-making is a fundamental aspect of primary care for low back pain. Two alternative approaches are providing fact sheets that list information about managing back pain or fact sheets that give advice on how to self-manage back pain, the comparative effects of which are unknown.

Objective: To determine the effects of 1-page fact sheets on patient-reported preparedness for shared decision-making among people with low back pain.

Design, setting, and participants: This 2-group parallel randomized clinical trial recruited 1080 adults from April 1, 2023, to April 30, 2024, who had recently seen their physician for uncomplicated low back pain. Participants were randomized to receive 1 of 2 one-page fact sheets. Outcomes were collected immediately after reading the fact sheet.

Interventions: The information sheet was a 1-page fact sheet from a reputable medical journal and listed guideline-recommended management options. The advice sheet was a 1-page fact sheet from a recent clinical care standard and provided advice on how to self-manage low back pain.

Main outcomes and measures: The primary outcome was patient-reported preparedness for decision-making, measured by the 100-point Preparation for Decision Making scale (where higher scores indicated higher preparedness for decision-making). Secondary outcomes included intentions for guideline-recommended interventions (staying active, physical therapies, and heat application) and nonrecommended interventions (imaging and opioid medicines). Analysis was performed on an intent-to-treat basis.

Results: The total study sample included 1080 patients (mean [SD] age, 51.9 [14.7] years; 764 women [70.7%]). After reading the fact sheet, mean (SD) scores for preparation for decision-making were 57.6 (26.5) in the information sheet group and 52.9 (26.2) in the advice sheet group (adjusted mean difference, 4.7 points; 95% CI, 1.0-8.5 points; P = .01). A larger effect was observed among participants with chronic low back pain (mean [SD], 58.3 [28.9] points with information sheet vs 51.9 [28.4] points with advice sheet; adjusted mean difference, 6.4 points; 95% CI, 1.7-11.0 points; P = .007) compared with those with acute low back pain (mean [SD], 57.8 [26.0] points with information sheet vs 56.6 [29.2] points with advice sheet; adjusted mean difference, 1.2 points; 95% CI, -4.9 to 7.4 points; P = .70). There were no significant between-group differences in intentions to use guideline-recommended or nonrecommended interventions.

Conclusion and relevance: In this randomized clinical trial among people who had recently seen their physician for uncomplicated low back pain, an information sheet listing management options was more effective than an advice sheet at preparing patients for shared decision-making. It is uncertain whether this effect is meaningful.

Trial registration: http://anzctr.org.au Identifier: ACTRN12623000603617.

Figure 1.. Flow of Participants Through the Study

Figure 2.. Effects of Information Sheets on Health Care–Seeking Intentions and Acceptability Measures

AOR indicates adjusted odds ratio.