Design of a Multicenter Randomized Controlled Trial comparing the effectiveness of shared decision making versus motivational interviewing plus cognitive behavioral therapy for voluntary opioid tapering: The INSPIRE study protocol.

BACKGROUND: This paper describes the design and protocol of a pragmatic, randomized trial to evaluate the comparative effectiveness of shared decision making versus motivational interviewing plus cognitive behavioral therapy for chronic pain for the voluntary tapering of opioid dose in adults with chronic noncancer pain. Integrated Services for Pain: Interventions to Reduce Pain Effectively (INSPIRE) is a multicenter, randomized trial conducted at three academic health centers in the southeastern United States. Participants are adults receiving long-term opioid therapy of at least 20 morphine milligram equivalents daily for chronic noncancer pain. METHODS: Participants were randomized to either the shared decision-making intervention or the motivational interviewing session and cognitive behavioral therapy for chronic pain intervention. All participants also received guideline-concordant care supporting opioid pharmacotherapy. The primary outcome was change from baseline in average daily prescribed opioid dose at 12 months, using prescribing data from electronic health records. Secondary outcomes were Patient-Reported Outcomes Measurement Information System Pain Interference and Physical Function at 12 months. CONCLUSION: This trial evaluates the comparative effectiveness of shared decision making versus motivational interviewing plus cognitive behavioral therapy for chronic pain for the voluntary tapering of opioid dose in adults with chronic noncancer pain. Results from this study can guide clinicians, researchers, and policymakers as they seek to reduce opioid prescribing and improve management of chronic pain. CLINICAL TRIALS REGISTRATION: ClinicalTrials.gov Identifier: NCT03454555 (https://clinicaltrials.gov/ct2/show/record/NCT03454555). Participant enrollment began on June 26, 2019.

Using RE-AIM to examine the potential public health impact of an integrated collaborative care intervention for weight and depression management in primary care: Results from the RAINBOW trial.

BACKGROUND: An integrated collaborative care intervention was used to treat primary care patients with comorbid obesity and depression in a randomized clinical trial. To increase wider uptake and dissemination, information is needed on translational potential. METHODS: The trial collected longitudinal, qualitative data at baseline, 6 months (end of intensive treatment), 12 months (end of maintenance treatment), and 24 months (end of follow-up). Semi-structured interviews (n = 142) were conducted with 54 out of 409 randomly selected trial participants and 37 other stakeholders, such as recruitment staff, intervention staff, and clinicians. Using a Framework Analysis approach, we examined themes across time and stakeholder groups according to the RE-AIM (Reach, Effectiveness, Adoption, Implementation, and Maintenance) framework. RESULTS: At baseline, participants and other stakeholders reported being skeptical of the collaborative care approach related to some RE-AIM dimensions. However, over time they indicated greater confidence regarding the potential for future public health impact. They also provided information on barriers and actionable information to enhance program reach, effectiveness, adoption, implementation, and maintenance. CONCLUSIONS: RE-AIM provided a useful framework for understanding how to increase the impact of a collaborative and integrative approach for treating comorbid obesity and depression. It also demonstrates the utility of using the framework as a planning tool early in the evidence-generation pipeline.

The Positive Facet of Self-compassion Predicts Self-reported Use of and Attitudes toward Desirable Difficulties in Learning.

Previous research found that introducing difficulties and challenges during learning has desirable outcomes. With the present work, we investigated the question how the use of and the attitudes toward such learning strategies (so-called desirable difficulties) are related to self-compassion, a concept that describes the tendency to be understanding and kind to oneself when confronted with negative experiences. Evidence suggests self-compassion to be linked to less fear of failing, and further to higher control beliefs and mastery goals in learning. Given that applying desirable difficulties in self-regulated learning implies increased challenges, and further, a higher likelihood to experience a feeling of failing, we expected that the use of desirable difficulties increases with levels of self-compassion. We tested this hypothesis in an online study (N = 136) in which self-compassion and the self-reported use of and attitudes toward strategies of desirable difficulties were assessed via respective questionnaires. Results of a correlation analysis yielded first evidence for our idea. Decomposing self-compassion into a positive and a negative facet showed that the positive, but not the negative, facet is positively correlated with attitudes toward and the use of desirable difficulties. Additionally, a regression analysis showed that the positive but not the negative facet predicted attitudes toward and use of desirable difficulties, when entering both facets simultaneously as predictors. Practical implications for learners are discussed.

Psychometric evaluation and design of patient-centered communication measures for cancer care settings.

OBJECTIVE: To evaluate the psychometric properties of questions that assess patient perceptions of patient-provider communication and design measures of patient-centered communication (PCC). METHODS: Participants (adults with colon or rectal cancer living in North Carolina) completed a survey at 2 to 3 months post-diagnosis. The survey included 87 questions in six PCC Functions: Exchanging Information, Fostering Health Relationships, Making Decisions, Responding to Emotions, Enabling Patient Self-Management, and Managing Uncertainty. For each Function we conducted factor analyses, item response theory modeling, and tests for differential item functioning, and assessed reliability and construct validity. RESULTS: Participants included 501 respondents; 46% had a high school education or less. Reliability within each Function ranged from 0.90 to 0.96. The PCC-Ca-36 (36-question survey; reliability=0.94) and PCC-Ca-6 (6-question survey; reliability=0.92) measures differentiated between individuals with poor and good health (i.e., known-groups validity) and were highly correlated with the HINTS communication scale (i.e., convergent validity). CONCLUSION: This study provides theory-grounded PCC measures found to be reliable and valid in colorectal cancer patients in North Carolina. Future work should evaluate measure validity over time and in other cancer populations. PRACTICE IMPLICATIONS: The PCC-Ca-36 and PCC-Ca-6 measures may be used for surveillance, intervention research, and quality improvement initiatives.

Mothers' guilt responses to children's obesity risk feedback.

This study explored the influence of family health history-based obesity risk feedback for their child on 147 overweight mothers' guilt related to children's lifestyle behaviors and passing down a genetic propensity for overweight. Mothers were randomized to receive, or not, obesity risk feedback for their 4- to 5-year-old child and then made food choices for them using a virtual reality-based buffet. Receipt of risk information increased lifestyle- and genetics-related guilt. Choosing fewer unhealthful foods for the child attenuated both types of guilt. Work in this area may aid in development of obesity risk feedback strategies that enhance child feeding.