Alcohol Use and Chronic Pain Among Primary Care Patients

Integrated Technology-Based Intervention to Reduce Heavy Drinking and Chronic Pain Among Patients in Primary Care

Chronic pain and unhealthy drinking are common co-occurring conditions among patients presenting to primary care. Given their impact on functioning and medical outcomes, there would be considerable benefit to developing an accessible, easily utilized, integrative approach to reduce unhealthy alcohol use and pain that can be readily incorporated into the primary care setting. The objective of this study is to test a smartphone-based intervention for reducing unhealthy alcohol use and pain in primary care patients, determine the feasibility of implementing this intervention in the primary care setting, provide effect size estimates of the intervention on drinking and chronic pain outcomes.

Heavy alcohol use represents a significant risk for morbidity and mortality. Unfortunately, addressing unhealthy patterns of alcohol use in primary care is often a challenge as patients typically present with co-morbid conditions that: (1) may make unhealthy drinking a lower priority health issue and (2) may impact the capacity for sustained alcohol-related change. Chronic pain is among the most common of these conditions among primary care patients. Pain is a frequent source of distress and disability among primary care patients and is one of the most frequent causes for visits. Pain is also an important trigger for alcohol use among primary care patients who drink and is associated with the experience of negative alcohol-related consequences and unhealthy drinking over time. The experience of pain has also been shown to be associated with poorer responses to alcohol interventions. Primary care physicians face a number of challenges when attempting to treat co-occurring unhealthy drinking and pain among their patients. Pain management and reduction of alcohol use among those who engage in heavy alcohol use is often not adequately achieved with pharmacological treatments nor are pharmacological treatments indicated for common pain conditions. Moreover, despite the availability of evidence-based psychosocial interventions for unhealthy drinking and chronic pain, patients with each of these conditions typically show poor adherence to treatment. Given the rates of pain and unhealthy alcohol use among primary care patients and their impact on functioning and medical outcomes, there would be considerable benefit to an accessible, easily utilized, integrative approach to treat heavy alcohol use and pain that can be readily incorporated into the primary care setting. The objectives of this study are to develop a smartphone-based intervention for reducing heavy alcohol use and pain in primary care patients, determine the feasibility of implementing this intervention in the primary care setting, provide effect size estimates of the intervention on outcomes, and develop procedures to conduct a Stage II efficacy trial.

Eight-week and 16-week assessments will be completed by assessor who is masked to intervention condition. Baseline assessment takes place before randomization

Smartphone-based intervention that includes in-person initial session and 8 video lessons, daily activities, and weekly check-ins.

Three items from the Brief Pain Inventory (BPI) to assess chronic pain. Range 0-30. Higher scores reflect worse outcomes

Four items from the BPI to assess chronic pain intensity. Each item 0-10. Higher scores reflect worse outcomes

Seven items from the BPI to assess chronic pain interference. Each item is 0-10. Higher scores reflect worse outcomes

Inclusion Criteria: 1 heavy drinking: defined as either [1] an average of more than 7(for women)/14 (for men) standard drinks per week over the past month or [2] one or more heavy drinking episodes (4+ standard drinks for women, 5+ standard drinks for men) 2 chronic pain: defined as non-cancer related pain of at least 3 months duration rated as moderate or greater (past week pain severity rating of 4 or greater on the BPI severity item) Exclusion Criteria: psychoactive medication for pain or alcohol use for fewer than 2 months history of bipolar disorder or schizophenia current expressed suicidal intent prior history of alcohol withdrawal related seizures or delirium tremens behavioral treatment for pain or alcohol use in the past 3 months any scheduled surgery within the next 6 months or acute life threatening illness that requires treatment

Data sharing procedures that will be implemented within one year of completion of the study. Specific data may be shared based on proposals received and reviewed by the study investigators and limited public-use data sets might be prepared and made available. In either case, data will be shared only after all planned reports of study findings have been prepared. Data to be shared will be de-identified to minimize the risk of deductive disclosure. Documentation will be provided for all shared data including copies of data collection forms, schedule of study assessments, data dictionaries documenting all original and derived variables, descriptive statistics for all variables included in the data sets, and a written description of the study conduct and noteworthy details anticipated to potentially affect data interpretation. Costs associated with producing data sets and analysis will be the responsibility of investigators seeking the data.

Data will be available after all planned reports of study findings have been prepared within one year of project completion. Data will be available upon request for 5 years following these reports

Specific data may be shared based on proposals received and reviewed by the study investigators and determined to have scientific merit.