Enhancing Patient Ability to Understand and Utilize Complex Information Concerning Medication Self-management

The aim of the proposed project is to compare the effectiveness of two strategies designed to enhance patient understanding of medication risks/benefits: (1) Medication Guides, mandated for many medications by the Food and Drug Administration and (2) Drug Facts Boxes, developed by Woloshin and Schwartz to enhance the usability of consumer medication information. The investigators will also assess whether the effectiveness of these communication strategies can be increased by Gist Reasoning Training, which is designed to enhance patients' ability to extract meaningful gist from complex information.The investigators anticipate enrolling 300 individuals with rheumatoid arthritis. The study will use a randomized controlled trial design with four study arms. Data will be collected primarily via self-administered, Internet-based surveys using REDCap. All participants will be followed for 6 months after the completion of baseline data collection.

Study Overview

• Status: Completed
• Conditions: Rheumatoid Arthritis
• Intervention / Treatment: Behavioral: Medication Guides; Behavioral: SMART Program; Behavioral: Drug Facts Boxes

Detailed Description

Rheumatoid arthritis (RA) is a systemic, autoimmune disorder affecting 0.5% to 1% of the adult population in developed countries worldwide. Current 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 reduce the risk of premature death. A major issue in implementing aggressive therapy in practice, however, involves patient reluctance to escalate therapy when they believe that their symptoms are tolerable, despite the presence of active disease, due to concerns about medications risks. Moreover, patients often find it difficult to obtain accurate and personally-relevant information about medication risks and benefits that is written in language they can understand. There is a clear gap between the information patients want about medication risks and benefits and the information they currently receive as part of routine care.

The aim of the proposed project is to compare the effectiveness of two strategies designed to enhance patient understanding of medication risks/benefits: (1) Medication Guides, mandated for many medications by the Food and Drug Administration and (2) Drug Facts Boxes, developed by Woloshin and Schwartz to enhance the usability of consumer medication information. The investigators will also assess whether the effectiveness of these communication strategies can be increased by Gist Reasoning Training, which is designed to enhance patients' ability to extract meaningful gist from complex information.

• Study Type: Interventional
• Enrollment (Actual): 286
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • University of North Carolina At Chapel Hill

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Age 18 years or older
2. Able to speak and read in English
3. Physician confirmed RA define by 1987 American College of Rheumatology criteria
4. Moderate or highly active rheumatoid arthritis (assess by Routine Assessment of Patient Index Data 3 (RAPID3) score > 2.0) and
5. Physician indicates patient is a candidate for initiation or escalation of Disease-modifying antirheumatic drug (DMARD) therapy

Exclusion Criteria:

1. Hearing or visually impaired

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Other CMI Only; Approximately 75 participants will be assigned to this study group. Participants will ONLY receive medication guides, or other comparable Consumer Medication Information (CMI), for rheumatoid arthritis medications.	Behavioral: Medication Guides; The investigators will compare the effectiveness of two types of written prescription drug information targeted for patients: (1) Medication Guides mandated by the Food and Drug Administration, and (2) Drug Facts Boxes, developed by Woloshin and Schwartz.
Experimental: Other CMI & SMART Program; Approximately 75 participants will be assigned to this study group. Participants will receive medication guides, or other comparable Consumer Medication Information (CMI), for rheumatoid arthritis medications AND will be enrolled into the Strategic Memory Advanced Reasoning Training (SMART) Program.	Behavioral: Medication Guides; The investigators will compare the effectiveness of two types of written prescription drug information targeted for patients: (1) Medication Guides mandated by the Food and Drug Administration, and (2) Drug Facts Boxes, developed by Woloshin and Schwartz.; Behavioral: SMART Program; The investigators will determine if the effectiveness of written medication information can be increased by Gist Reasoning Training, delivered via the SMART Program, which is designed to enhance patients' ability to extract meaningful gist from complex information.
Experimental: Drug Facts Boxes Only; Approximately 75 participants will be assigned to this study group. Participants will ONLY receive Drug Facts Boxes for rheumatoid arthritis medications.	Behavioral: Drug Facts Boxes; The investigators will compare the effectiveness of two types of written prescription drug information targeted for patients: (1) Medication Guides mandated by the Food and Drug Administration, and (2) Drug Facts Boxes, developed by Woloshin and Schwartz.
Experimental: Drug Facts Boxes & SMART Program; Approximately 75 participants will be assigned to this study group. Participants will receive Drug Facts Boxes for rheumatoid arthritis medicationsAND will be enrolled into the Strategic Memory Advanced Reasoning Training (SMART) Program.	Behavioral: SMART Program; The investigators will determine if the effectiveness of written medication information can be increased by Gist Reasoning Training, delivered via the SMART Program, which is designed to enhance patients' ability to extract meaningful gist from complex information.; Behavioral: Drug Facts Boxes; The investigators will compare the effectiveness of two types of written prescription drug information targeted for patients: (1) Medication Guides mandated by the Food and Drug Administration, and (2) Drug Facts Boxes, developed by Woloshin and Schwartz.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Classified as Having Made an Informed Decision at 6 Months	Informed decision making is characterized by making a value-consistent decision based on accurate knowledge. Knowledge will be assessed as described under Outcome 2. Values will be assessed using a 10-item scale developed by Fraenkel et al. Scores on this scale can range from 0 to 10, with lower scores reflecting a reluctance to use medications to control disease activity. Participants will be classified as having made an informed choice if they: (1) answered at least 85% of the knowledge items correctly, scored 6 or more on the values scale, and are currently taking one or more DMARDS OR (2) answered 85% of the knowledge items correctly, scored 5 or less on the values measure, and are not currently taking a DMARD. Otherwise, individuals will be classified as not having made an informed choice.	Month 6 Follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Knowledge of the Risks and Benefits Associated With DMARD Therapy at 6 Months Adjusted for Baseline	Knowledge of DMARD risks and benefits will be assessed by measures developed by Fraenkel et al., Barton et al., and Fayet et al. The combined measure will have a total of 36 items. Most items are answered on a true/false scale (with a don't know option provided). Each correct response will receive 1-point (maximum of 36 points). Scores transformed to a 100-point scale (ranging from 0-100) with higher values reflecting greater knowledge.	Month 6 Follow-up
Mean Values at 6-Months Adjusted for Baseline	Values. Questions included in the self-administered questionnaires asked participants to indicate the extent to which they agreed or disagreed with 10 simple values statements (e.g., It is OK to ignore the risk of a serious side effect if it is extremely rare; It is better to continue with the pain I know than to change my medications) developed by Fraenkel and colleagues. Responses were recorded on a 4-point scale ranging from 1=Strongly Agree to 4=Strongly Disagree. Responses were then summed and rescored to yield a composite scale that ranged from -15 to +15, where positive numbers reflected values favoring the use of medications to control rheumatoid arthritis (RA) disease activity.	Month 6 Follow-up
Mean Gist Reasoning Ability, Lesson Quality at 6 Month Follow-up Adjusted for Baseline	The investigators used the Test of Strategic Learning (TOSL) to quantify participants' ability to abstract gist meanings from complex text. The TOSL consists of 4 text passages varying in length (from 291 to 575 words) and complexity. Each participant responded to one passage at each time point. Participants were asked to provide a summary of the original text, focused on bottom-line-meaning rather than specific details. Responses were scored to assess the quality of high-level interpretations (Lesson Quality, range 0 to 5) using an objective scoring system by a trained and experienced rater, blinded to participants' group assignment and time point of testing. Higher scores reflect better lesson quality.	Month 6 Follow-up
Mean Gist Reasoning Ability, Complex Abstraction at 6-Month Follow-up Adjusted for Baseline	The investigators used the Test of Strategic Learning (TOSL) to quantify participants' ability to abstract gist meanings from complex text. The TOSL consists of 4 text passages varying in length (from 291 to 575 words) and complexity. Each participant responded to one passage at each time point. Participants were asked to provide a summary of the original text, focused on bottom-line-meaning rather than specific details. Responses were scored to assess the number of abstracted ideas (Complex Abstraction, range 0 to 8) using an objective scoring system by a trained and experienced rater, blinded to participants' group assignment and time point of testing. Higher scores indicate more ideas abstracted. The investigators will assess change in the total score over time from baseline to 6 month follow-up.	Month 6 Follow-up
Mean Satisfaction With Medication Information at 6-Month Follow-up Adjusted for Baseline	This outcome will be assessed by the 17-item Satisfaction with Information about Medicines Scale (SIMS). Items ask participants to rate the amount of information they have received about different aspects of their medications. Responses are summed across items to yield a total score with a possible range of 0 to 17, with higher scores reflecting greater satisfaction with the amount of information received.	Month 6 Follow-up
Mean Overall Treatment Satisfaction at 6-Month Follow-up Adjusted for Baseline	The Treatment Satisfaction Questionnaire for Medication (TSQM-9) will be used to assess treatment satisfaction. TSQM-9 has 3 subscales: effectiveness, convenience and overall satisfaction. Items ask participants to rate their satisfaction with difference aspect of their treatment regimen on a 7-point scale with endpoints labeled, Extremely Dissatisfied (1) and Extremely Satisfied (7). Internal consistency of each subscale has been demonstrated with Cronbach's alpha exceeding 0.80 for each sub-scale. Each subscale has been shown to discriminate between individuals classified as exhibiting Low vs. Medium medication adherence. The investigators combined items across all three subscales to yield a measure of overall treatment satisfaction (range: 0 to 100, with higher scores reflecting greater satisfaction).	Month 6 Follow-up
Mean Arthritis Self-Efficacy at 6-Month Follow-up Adjusted for Baseline	The investigators will assess confidence in one's ability to manage arthritis symptoms in different situations via the 8-item Arthritis Self-Efficacy Scale (e.g., keep pain from interfering with things participants want to do). Responses are recorded on a 100-point scale with endpoints labeled "Very Uncertain" and "Very Certain". This measure has been widely used in arthritis patient populations for over two decades and has been shown to have excellent psychometric properties, including high internal consistency (Cronbach's alpha generally exceeds 0.90) and sensitivity to change following participation in illness self-management programs. To create a total scale score, the investigators summed participant responses across the items in the scale and divided by the number of items answered. Thus, the scale has a possible range of 0 to 100. Higher scores indicate greater self-efficacy.	Month 6 Follow-up
Mean Medication Adherence at 6-Month Follow-up Adjusted for Baseline	Medication Adherence was assessed by a single question that asked: "All things considered, how much of the time do you use your RA medications EXACTLY as directed?" Responses were recorded on a 100-point visual analog scale with endpoints labeled "None of the Time" and "All of the time". Higher values reflect greater medication adherence.	Month 6 Follow-up
Mean Illness Intrusiveness at 6-Month Follow-up Adjusted for Baseline	Illness Intrusiveness will be assessed by the 13-item Illness Intrusiveness Ratings Scale. Items ask respondents to rate the degree to which their "illness and/or its treatment" interferes with aspects of life that are essential for quality of life. Responses will be recorded on a visual analog scale, with endpoints labeled Not Very Much (0) and Very Much (100). The instrument will be scored by summing across all items and dividing by the number of items answered to yield a total score ranging from 0 to 100 where higher values reflect greater illness intrusiveness.	Month 6 Follow-up
Mean Health Distress at 6-Month Follow-up Adjusted for Baseline	Health Distress will be assessed by the 4-item measure developed by Lorig and colleagues. This measure was adapted from the Medical Outcomes Study health distress scare for use in arthritis populations. The adapted measure has demonstrated high internal consistency (Cronbach's alpha= .87) and responsiveness to change following completion of an arthritis self-management course. Participants will respond to each question on a 6-point scale, ranging from None of the Time (0) to All of the Time (5). Thus, the total score will range from 0 to 5, with higher scores reflecting greater Health Distress.	Month 6 Follow-up
Mean Global Health Status at 6-Month Follow-up Adjusted for Baseline	This outcome will be assessed by a single-item asking participants to rate their current health on a 5-point scare where 1=Poor, 2=Fair, 3= Good, 4= Very Good, and 5= Excellent. This item is part of the Medical Outcomes Study Core Survey Instrument and responses have been shown to predict mortality and health care utilization as well as multi-item health status measures.	Month 6 Follow-up
Mean Disease Activity at 6-Month Follow-up Adjusted for Baseline	Disease Activity will be assess using the Routine Assessment of Patient Index Data 3 (RAPID3). This instrument is based on the Multi-Dimensional Health Assessment Questionnaire (MDHAQ), which is adapted from the standard HAQ. The RAPID3 includes the 3 Core Data Set measures of physical function, pain, and patient global estimate. The score for physical function ranges from 0 to 10 and is calculated by adding the ten activities of daily living, each scored from 0 to 3 by the patient and dividing the total raw score by 3. Pain and global estimate of health are measured on a likert scale from 0 to 10. The three 0-10 scores for physical function, pain, and global assessment of health are added together and divided by 3 to create a composite score, ranging from 0 to 10. Higher values reflect greater disease activity.	Month 6 Follow-up
Mean Depression at 6-Month Follow-up Adjusted for Baseline	Depression will be assessed using the Neuro-QOL (Quality of Life in Neurological Disorders) Version 1 item bank. Raw scores are rescaled to a standardized T-score with a mean of 50 and a standard deviation (SD) of 10. The United States general population is used as the reference group. A higher T-score represents greater depression.Thus, a person who has a T-score of 70 is two SDs above the average level of depression observed in the referenced population.	Month 6 Follow-up
Mean Fatigue at 6-Month Follow-up Adjusted for Baseline	Fatigue will be assessed using the Neuro-QOL (Quality of Life in Neurological Disorders) Version 1 item bank. Raw scores are rescaled to a standardized T-score with a mean of 50 and a standard deviation (SD) of 10. The United States general population is used as the reference group. A higher T-score represents greater fatigue.Thus, a person who has a T-score of 70 is two SDs above the average level of fatigue observed in the referenced population.	Month 6 Follow-up
Mean Health Literacy at 6-Month Follow-up Adjusted for Baseline	Health literacy will be assessed via the Newest Vital Sign (NVS). This instrument, which tests literacy skills for both numbers and words, has been validated against a previously validated measure of health literacy (the TOFHLA). Participants are given a specially designed ice cream nutrition label to review and are asked a series of questions about the label. 1-point is given for each correct answer (maximum of 6 points). Scores transformed to a 100-point scale (ranging from 0-100) with higher values reflecting greater health literacy.	Month 6 Follow-up
Information Seeking: Participating in BetterChoices, BetterHealth	After the 6 week follow-up interview, all participants were given an opportunity to take part in the BetterChoices, BetterHealth program. To assess information seeking, the investigators tracked whether or not participants enrolled in the class and attended at least one class session. This variable was coded such that: 0=Either did not enroll or did not attend any class sessions, 1=Enrolled and attended at least one class session.	6 months
Information Seeking: Use of RA Self-Management Website	The investigators created a website that provided easy access to information about RA, treatment options, and self-management strategies. Participants were emailed a link to this website immediately after completion of 6-week follow-up data collection. The investigators used Google analytics to track whether participants accessed the website.	6 months
Mean Visual Selective Learning at 6-Month Follow-up Adjusted for Baseline	The Visual Selective Learning (VSL) task will be administered as part of telephone interviews by showing participants 3 lists of 16 words via a PowerPoint presentation embedded in a YouTube video. Each word will appear on a separate screen for 1 second. Half of the words will be in uppercase and half will be in lowercase. In some trials, participants will be instructed that uppercase words are valued at 10 points and lowercase words at 1 point; in other trials, the point value was the opposite. Participants will be told to remember as many words as they could, but that their goal is to earn as many points as possible. Different word lists will be used at each time point and the lists will be balanced across participants over the course of the study using procedures parallel to those for the TOSL. At each time point, scores will be summed across the three lists, yielding a composite score with a possible range from 0 to 264, with higher numbers reflect greater VSL.	Month 6 Follow-up
Mean Medication Self-Management Knowledge	Medication Self-Management Knowledge will be assessed using a 45-item medication-specific measure tailored to the medications each participant reports using and developed specifically for this study. The questions will draw on information found in the medication information provided to participants. Correct answers will be summed across the 45 items. Scores transformed to a 100-point scale (ranging from 0-100) with higher values reflecting greater knowledge.	6 months
Mean Verbatim Recall of Information Concerning Medication Benefits and Risks	Verbatim recall of information concerning potential medication benefits and harms will be assessed by medication-specific items developed specifically for this study. For each medication, the investigators will identify one potential benefit and one potential harm listed in the Drug Facts Box. Each question will ask participants about the probability of benefit/harm using a multiple-choice response format. To minimize response burden, participants will be asked these questions in relation to only one of their current RA medications. Correct responses will be summed across the benefit and harm items to yield a score ranging from 0 to 2. Higher numbers reflect greater verbatim recall.	6 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Interest in Information About Treatment Options: Viewed at Least One Webpage	After participants complete the baseline questionnaire, they were directed to a website that provides written prescription drug information for medications used to treat RA. From baseline to the 6-month follow-up, the investigators electronically tracked the number of webpages viewed and whether participants viewed any of the webpages.	6 months
Patient Interest in Information About Treatment Options: Number of Pages Viewed	After participants complete the baseline questionnaire, they were directed to a website that provides written prescription drug information for medications used to treat RA. From baseline to the 6-month follow-up, the investigators electronically tracked the number of webpages viewed and whether participants viewed any of the webpages.	6 months
Percentage of Participants Using a DMARD (Disease-Modifying Antirheumatic Drug) at 6-Month Follow-up	DMARD usage will be assessed via online questionnaires. Participants will be shown a checklist of 19 medications used to treat RA (abatacept, adalimumab, azathioprine, certolizumab pegol, cyclosporine, etanercept, golimumab, gold, hydroxychloroquine, infliximab, leflunomide, methotrexate pill, methotrexate shot, minocycline, rituximab, sulfasalazine, tocilizumab infusion, tocilizumab shot, and tofacitinib) and asked to check all of those that they are currently using. Participants will also be to check an option labeled None of the above. DMARD Usage will be scored as "0" if the participant reports using no DMARDS and "1" if the participant reports using one or more DMARDS.	Month 6 Follow-up

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Collaborators: Patient-Centered Outcomes Research Institute; University of Alabama at Birmingham; University of Texas Southwestern Medical Center; Dartmouth College; Cornell University; The University of Texas at Dallas; University of Pittsburgh Medical Center; Global Healthy Living Foundation
• Investigators: Principal Investigator: Susan J Blalock, PhD, UNC; Study Director: Caprice Hunt, MPH, UNC

Publications and helpful links

General Publications

• Blalock SJ, Solow EB, Reyna VF, Keebler M, Carpenter D, Hunt C, Hickey G, Curtis JR, O'Neill K, Chapman SB. Enhancing Patient Understanding of Medication Risks and Benefits. Arthritis Care Res (Hoboken). 2022 Jan;74(1):142-150. doi: 10.1002/acr.24421. Epub 2021 Dec 22.

Study record dates

Study Major Dates

• Study Start: September 1, 2016
• Primary Completion (Actual): December 31, 2018
• Study Completion (Actual): December 31, 2018

Study Registration Dates

• First Submitted: June 27, 2016
• First Submitted That Met QC Criteria: June 27, 2016
• First Posted (Estimate): June 30, 2016

Study Record Updates

• Last Update Posted (Actual): January 18, 2020
• Last Update Submitted That Met QC Criteria: January 14, 2020
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid
• Other Study ID Numbers: 15-2972

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The investigators will create a web-site to disseminate study findings. Access to the website will not be restricted in any way. The website will provide a link for individuals to obtain a copy of study data. Individuals will be required to complete a form to request the data, indicating their name, contact information, and the research questions they plan to address. The investigators will then provide individuals with a complete, cleaned, deidentified copy of the final Statistical Analysis Software (SAS) dataset and a copy of the study protocol which will include all of the information needed to replicate the analyses or perform secondary analyses. The investigators will use SharePoint to provide these materials to those who request them. The link providing access to study data will appear and be active within nine months following the final year of funding. The reason for not putting the data onto the study website is to enable the investigators to track data usage.
• IPD Sharing Time Frame: All materials will be made available by 2/15/2020 and will remain available via the website for at least two years.
• IPD Sharing Access Criteria: Completion of a form indicating the name of the requester, contact information, and the research questions the requester plans to address. Completion of this form is only required to ensure that the requester is not a bot.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE