Person:

Ahern, David

Background: Chronic obstructive pulmonary disease (COPD) is a progressive, debilitating disease associated with significant clinical burden and is estimated to affect 15 million individuals in the US. Although a large number of individuals are diagnosed with COPD, many individuals still remain undiagnosed due to the slow progression of the disorder and lack of recognition of early symptoms. Not only is there under-diagnosis but there is also evidence of sub-optimal evidence-based treatment of those who have COPD. Despite the development of international COPD guidelines, many primary care physicians who care for the majority of patients with COPD are not translating this evidence into effective clinical practice. Method/Design This paper describes the design and rationale for a randomized, cluster design trial (RCT) aimed at translating the COPD evidence-based guidelines into clinical care in primary care practices. During Phase 1, a needs assessment evaluated barriers and facilitators to implementation of COPD guidelines into clinical practice through focus groups of primary care patients and providers. Using formative evaluation and feedback from focus groups, three tools were developed. These include a computerized patient activation tool (an interactive iPad with wireless data transfer to the spirometer); a web-based COPD guideline tool to be used by primary care providers as a decision support tool; and a COPD patient education toolkit to be used by the practice team. During phase II, an RCT will be performed with one year of intervention within 30 primary care practices. The effectiveness of the materials developed in Phase I are being tested in Phase II regarding physician performance of COPD guideline implementation and the improvement in the clinically relevant outcomes (appropriate diagnosis and management of COPD) compared to usual care. We will also examine the use of a patient activation tool - ‘MyLungAge’ - to prompt patients at risk for or who have COPD to request spirometry confirmation and to request support for smoking cessation if a smoker. Discussion Using a multi-modal intervention of patient activation and a technology-supported health care provider team, we are testing the effectiveness of this intervention in activating patients and improving physician performance around COPD guideline implementation. Trial registration ClinicalTrials.gov, NCT01237561

Osteoarthritis (OA) is a leading cause of disability in the United States and globally, [14; 39] and the burdens it causes are expected to increase as the world’s population ages [14; 23]. Non-pharmacological treatments are a recommended component of current guidelines for treating OA pain [53]. Although evidence is mixed that people benefit from non-pharmacological treatments such self-management interventions and patient education [e.g., 17; 25; 38; 45], one non-pharmacological therapy—pain coping skills training (PCST)—has demonstrated more consistently positive outcomes [38]. PCST focuses specifically on educating people about cognitive and behavioral pain coping skills and helping them master those skills so they can become more actively involved in managing their pain--the most common and debilitating OA symptom [33]. It includes two main components: 1) a rationale linking pain to patterns of cognitive, emotional, and behavioral pain responses, and 2) training in skills such as attention diversion (e.g., relaxation), cognitive restructuring (to address catastrophizing and other maladaptive cognitive patterns), and activity patterns (e.g., activity-rest cycling). It has traditionally been delivered in-person by a trained therapist over 10-12 weeks. Randomized controlled trials demonstrate that PCST significantly improves pain and other outcomes [e.g., 24; 29; 30; 31; 63]. Moreover, interventions such as PCST have fewer adverse effects than pharmacological pain treatments and are well-received by patients.

Thus, research supports the efficacy of in-person PCST. However, access to this intervention is limited by barriers such as lack of trained therapists, the substantial resources needed to deliver it, and the need for people to travel to in-person training held at scheduled times [22; 59] There is a clear need for an approach that makes PCST more accessible. The Internet—a proven method for delivering behavioral interventions—provides an avenue for meeting this need [15; 42; 58; 65], especially given older adults’ increasing use of the Internet [69].

The present pilot study was a two-arm randomized controlled trial conducted to evaluate the potential efficacy and acceptability of an eight-week, automated, Internet-based version of PCST called PainCOACH. This program was designed to retain key therapeutic features of the in-person PCST protocol, simulating in-person PCST while presenting training in an easy-to-use format with guided instruction, individualized feedback, interactive exercises, and animated demonstrations [57]. We hypothesized that: (1) PainCOACH would reduce pain (primary outcome) and improve pain-related interference with functioning, pain-related anxiety, self-efficacy for pain management, and positive and negative affect; and (2) acceptability would be high. Our overarching goal was to use findings from this early-stage research to refine the program and study protocol in preparation for a larger-scale trial.

Additionally, we explored sex differences in responses to PainCOACH, based on evidence in our own lab and others showing significant sex differences in pain, pain responses, pain behavior, and pain coping in people with OA [e.g., 1; 19; 27; 32; see 54; 62; 67]. The potential for men and women to respond differently to pain interventions is important but rarely evaluated in research.