Providing patients with information about disease-modifying anti-rheumatic drugs: Individually or in groups? A pilot randomized controlled trial comparing adherence and satisfaction.

BACKGROUND: Communicating information about disease-modifying anti-rheumatic drugs (DMARDs) before patients start treatment is a key role for some rheumatology clinical nurse specialists. This is done in our unit to promote understanding of the risks and benefits of drug therapy and encourage timely and reliable use of DMARDs. Information is routinely provided individually but this can lead to delays in starting treatment because of limited nursing resources. In this randomized trial we tested the feasibility of giving patients, who were about to start on a DMARD, information about the drug in groups and compared this with information given individually.
METHODS: Adults with a clinical diagnosis of rheumatoid arthritis or psoriatic arthritis who were referred to the nursing team for counselling about starting on methotrexate, sulfasalazine or leflunomide were included. Patients who had previously taken a DMARD were not excluded and those consenting were randomized to receive drug information individually or in groups (of three to six patients). We provided all patients with written materials about the relevant drug and discussed the risks and benefits of drug use verbally. Patients allocated to group counselling received this intervention in a teaching room, with a slide presentation. The primary outcome was adherence with medication use, ascertained by pill counts, self-report diaries and prescription dispensation. Secondary outcomes included satisfaction with information about medicines (SIMS) by questionnaire; time taken to provide information; adherence to scheduled hospital appointments and blood monitoring schedules; and DMARD continuation rates at four and twelve months.
RESULTS: Of 127 eligible patients referred for counselling about DMARDs, 62 consented to take part: 32 were randomized to receive drug information individually and 30 to receiving it in groups. Patients allocated to the two different interventions were comparable for age and diagnoses at baseline but more patients allocated individual counselling had not taken a DMARD previously: 56% (18/32) versus 20% (6/30). More patients counselled in groups were adherent (27/30; 90%) compared with patients counselled individually (22/32; 69%; p = 0.06) by pill counts. However, on self-report diaries, similar proportions were adherent (group counselling 97% (29/30) versus individual 94% (30/32); p = 1.0). All but two prescriptions were dispensed. More patients allocated to individual counselling missed at least one blood monitoring visit (25% versus 17%; p = 0.54) and at least one scheduled clinic visit (19% versus 3%; p = 0.10). SIMS scores indicated high levels of patient satisfaction and were similar for both groups. The time taken to run group and individual counselling sessions were similar (median of 35 minutes versus 33 minutes, respectively). Nursing time per individual patient in those allocated group counselling was 11.6 minutes. Drug continuation rates were higher for those counselled in groups compared with those counselled individually: at four months, 73% versus 63 %; p = 0.42; at twelve months, 47% versus 38%; p = 0.61).
CONCLUSIONS: Our pilot study demonstrated the feasibility of providing counselling on DMARDs to groups of patients with important time savings for specialist nurses and while maintaining high levels of patient satisfaction. There was a trend for better outcomes in terms of adherence and drug continuation rates for patients counselled in groups, indicating potential benefits from group interactions. However, these findings need to be investigated further in a larger, fully powered trial. 2008 John Wiley & Sons, Ltd.

RCT Entities:   Population Interventions Outcomes