Comparing two programs for helping patients make informed decisions about rheumatoid arthritis treatment / Susan J. Blalock [and 11 others]

BACKGROUND: Rheumatoid arthritis (RA) is a systemic, autoimmune disorder affecting nearly 1% of the US adult population. Current therapeutic guidelines underscore the importance of aggressive treatment of RA with disease-modifying antirheumatic drugs (DMARDs) to control inflammation. Aggressive treatment has been shown to improve patient-centered outcomes, including better symptom control, functional status, and health-related quality of life, and reduced risk of premature death. OBJECTIVES: The aim of the study was to evaluate the effectiveness of the Drug Facts box format for presenting written information concerning medications used to manage RA and the Strategic Memory Advanced Reasoning Training (SMART) program to enhance gist reasoning ability. DESIGN: The study used a 2 × 2 factorial research design. A total of 286 patients who met the following inclusion criteria participated: aged ≥18 years, diagnosis of physician-confirmed RA, moderate-to-severe disease activity as assessed via the Routine Assessment of Patient Index Data 3 (RAPID3), the absence of medical conditions that could prevent escalation of DMARD therapy, email and internet access, and absence of hearing or visual deficits that would prevent them from accessing the interventions. Participants were randomly assigned to 1 of 4 study groups: (1) Drug Facts box only, (2) Drug Facts box plus the SMART program, (3) other consumer medication information (CMI) only, and (4) other CMI plus the SMART program. Data were collected via telephone interviews and online, self-administered questionnaires at 4 data collection points: baseline (before intervention delivery) and 6 weeks, 3 months, and 6 months after baseline. The primary outcome variable was informed decision-making, defined as making a decision consistent with one's values concerning the use of aggressive treatment to manage RA disease activity in the presence of adequate knowledge. At each data collection point, participants were classified as meeting the criteria for informed decision-making if they 1. answered at least 85% of the items correctly on a measure assessing knowledge of medications used to treat RA; scored >0 on a scale assessing attitudes concerning the use of medications to control RA disease activity, where positive numbers reflected more positive attitudes; and were using a DMARD OR2. answered at least 85% of the knowledge items correctly, scored ≤0 on the attitudes scale, and were not using a DMARD. RESULTS: We experienced a high level of attrition (23%) from baseline to the 6-month follow-up. In addition, participation in intervention activities was modest. Of the 143 participants assigned to receive SMART, 38.5% (n = 55) completed at least 3 of the 4 class sessions. All study participants had access to a website with RA medication information, either the Drug Facts box website or the other-CMI website, depending on group assignment. The percentage of participants who viewed at least 1 webpage on these sites varied across study groups, ranging from 23.4% to 53.9%. In our primary analyses, we found no support for our hypotheses that participants would be more likely to meet the criteria for informed decision-making at the 6-month follow-up if they were assigned to receive (1) medication information via the Drug Facts box format vs with the other-CMI format, (2) gist reasoning training delivered via the SMART program vs no training, or (3) Drug Facts box-formatted information plus the SMART program vs individuals in the other 3 groups. Among participants randomly assigned to receive information in the Drug Facts box format, 46.3% met the criteria for informed decision-making at the 6-month follow-up, compared with 47.2% of participants randomly assigned to receive information in the other-CMI format (difference = 0.9; 95% CI, −10.7 to 12.5; P = .88). Among participants randomly assigned to the SMART program, 49.4% met the criteria for informed decision-making at the 6-month follow-up, compared with 44.2% of participants randomly assigned to the no-SMART groups (difference = 5.2; 95% CI, −6.4 to 16.7; P = .38). Finally, among participants randomly assigned to receive Drug Facts box-formatted information combined with the SMART program, 42.2% met the criteria for informed decision-making at the 6-month follow-up, compared with 48.2% of participants randomly assigned to other study groups (difference = −6.0; 95% CI, −19.5 to 7.7; P = .40). However, in unplanned exploratory analyses to determine if the effects of the interventions varied as a function of whether participants met the criteria for informed decision-making at baseline, we found a significant interaction (odds ratio, 0.20; 95% CI, 0.06-0.68; P = .01) at the 6-month follow-up between informed decision-making at baseline and assignment to SMART vs assignment to no SMART. Among participants in the SMART group who did not meet the criteria for informed decision-making at baseline, 40.3% met the criteria at 6-month follow-up, compared with 23.6% of participants in the no-SMART group (mean difference = 18.9; 95% CI, 5.6-32.2; P = .007). Among participants classified as meeting the criteria for informed decision-making at baseline, the difference between the SMART and no-SMART groups was not statistically significant (mean difference = −15.2; 95% CI, −32.7 to 2.4; P = .09). CONCLUSIONS: We found no support for our hypotheses that providing participants with information via the Drug Facts box format and gist reasoning training delivered via the SMART program, either alone or in combination, would have a beneficial effect on informed decision-making in patients with RA. However, the findings from our unplanned exploratory analyses suggest that participation in the SMART program may have a beneficial effect on informed decision-making among patients with inadequate knowledge concerning therapeutic options at baseline or whose current behavior is inconsistent with their values. Because this finding emerged from unplanned exploratory analyses, additional research is needed to determine whether it can be replicated. Future studies should focus on individuals with RA who do not meet the criteria for informed decision-making at baseline and should target patients at a point in time when changes to their medication regimen are being considered. LIMITATIONS: Many study participants did not use the intervention materials. This likely diluted the intervention effects and decreased our ability to detect interactions between the experimental conditions. In addition, we experienced a high level of attrition (23%) from baseline to the 6-month follow-up and differential attrition across study groups. Most importantly, participants assigned to SMART were more likely to drop out of the study than were participants assigned to the no-SMART group..

Medienart:	E-Book

Erscheinungsjahr:	[2020]
Erschienen:	Washington, D.C.: Patient-Centered Outcomes Research Institute (PCORI) ; 2020

Reihe:	Final research report

Sprache:	Englisch

Beteiligte Personen:	Blalock, Susan J. [VerfasserIn]

Links:	www.ncbi.nlm.nih.gov [teilw. kostenfrei]

Themen:	Arthritis, Rheumatoid Comparative Effectiveness Research Decision Making, Shared Patient Participation Treatment Outcome

Anmerkungen:	Includes bibliographical references. - Description based on online resource; title from PDF title page (viewed December 13, 2023)

Umfang:	1 online resource (1 PDF file (120 pages)) ; illustrations.

Förderinstitution / Projekttitel:

PPN (Katalog-ID):	1877336793