Incorporating Patient Preferences Into Decisions About Chronic Pain Management (The Pain APP Study)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 80
- Locations
- 2
- Primary Endpoint
- CG CAHPS (adult, Clinician and Group Survey)
Study Overview
Brief Summary
The investigators seek to understand the preferences, goals, and perspectives of patients with chronic pain and their health care providers (HCPs) to create a patient-centered decision support tool. This tool, aimed at patients and HCPs, should improve patient-provider communication and chronic pain management. The investigators' long-term goal is to improve the quality of life of patients with chronic pain. The investigators target adults with chronic unremitting pain and HCPs who manage patients with chronic pain, including primary care providers and pain specialists.
A pilot randomized controlled trial (RCT) will measure the impact of a new online tool that the investigators developed (Pain-APP) in a representative sample of adults with chronic pain, including approximately 50 patients and 4-15 HCPs. Eligible patients will be enrolled online, and after informed consent and eliciting baseline socio-demographic information, randomized online to either Pain-APP or the control group, which will consist of online educational materials at the ACPA website (https://theacpa.org/Communication-Tools). Patients in both groups will be assessed online before, just after viewing the intervention materials, just after the index clinic visit, and 1 month later. Patient-reported outcomes include patient-provider communication, pain intensity and interference, attitudes towards and use of opioid medication.
Detailed Description
Having completed our formative work, development and refinement of PainApp, the investigators will evaluate it in a small pilot randomized controlled trial (RCT) on a representative sample of patients with chronic pain and their HCPs.
The investigators will conduct a small RCT, including up to 50 patients and 5-15 HCPs. Eligible patients will be enrolled online. After informed consent, they will be randomized to either Pain-APP or the control group, which will consist of online educational materials (TheACPA.org). Patients in both groups will be assessed before, immediately after viewing the tool, shortly after the index clinic visit, and 1 month later. Patient-reported outcomes include patient-provider communication, pain intensity and interference, physical function, and depression (See Table 3). The investigators also include qualitative patient evaluations on a sampling (<20%) of patients to capture the full range of its impact and to explore potential mechanisms of action. Structured phone interviews, including open-ended questions, will assess patient perceptions of the platform, perceptions about how it affected communication and decisions making about treatments, trust in their HCP, and self-efficacy.
HCPs will be surveyed shortly after the patient encounter to assess acceptability of the tool, its perceived utility, and its impact on clinical efficiency. Additionally, quality of the patient encounter, ease of assessing patients with pain and of making decisions regarding treatments to manage that patient's pain will be evaluated using previously developed instruments.
The Study's Main Hypothesis: Compared to control, patients assigned to Pain-APP will have better patient-HCP communication.
Phase I data analyses plan: Multidimensional scaling was used to analyze the Nominal Group Technique (NGT) and card sort data. Hierarchical cluster analysis was used to identify subgroups of homogeneous strategies. Cognitive maps reflecting different patterns of goals and shared decision making (SDM) strategies were developed for patients and HCPs. These analyses helped the investigators understand how goals/strategies are viewed and organized by our stakeholders, which informed the design of PainApp.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- Double (Participant, Care Provider)
Masking Description
Participants are not aware of whether they are in the treatment or control group. Providers are not informed which group a patient is in, however, because the intervention generates a summary page that the patient may choose to send to their provider, the provider would be aware of a patients' group assignment if they shared the summary with the provider.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •chronic pain for at least 1 year.
- •upcoming appointment with a referring health care provider about their chronic pain within the next 3 months.
Exclusion Criteria
- •primary cause of pain due to cardiovascular or gastrointestinal problem
- •unable or unwilling to give informed consent
- •no access to internet
- •unable to use a computer
- •currently pregnant
- •Unable to speak English
Outcomes
Primary Outcomes
CG CAHPS (adult, Clinician and Group Survey)
Time Frame: within 3 days of seeing their HCP
The study uses a composite measure comprised of the items from the CG CAHPS survey that relate to shared decision making, including self-reported patient-provider communication (explained things, listened carefully, showed respect, spent enough time), patient rating of provider, care coordination (provider knew important information about the patient's medical history), rating of overall health and overall mental or emotional health.
The 10-item satisfaction with communication subscale of the COMRADE scale
Time Frame: within 3 days of seeing their HCP
The the Combined Outcome Measure for Risk Communication and Treatment Decision Making Effectiveness (COMRADE ) (Edwards 2003) is a 20 item patient-based outcome measure, with two sub-scales for 'risk communication' and 'confidence in decision'. It is a self-reported measure of patient-provider communication. Scores from the satisfaction with communication subscale are summed to produce a total score for that subscale. A higher score corresponds to higher satisfaction. Maximum score on the subscale is 20, minimum is 0.
Secondary Outcomes
- The Brief Pain Inventory(immediately after viewing the intervention, just after seeing their HCP, and 1 month later.)
- Opioid use(just after seeing their HCP and 1 month later.)
- The Control Preference Scale(immediately after viewing the intervention, just after seeing their HCP)
- Attitude towards opioids, drawn, in part, from Prescribed Opioids Difficulty Scale(immediately after viewing the intervention, just after seeing their HCP, and 1 month later.)
- The Decision Self-Efficacy Scale(immediately after viewing the intervention, just after seeing their HCP, and 1 month later.)
Investigators
Nananda Col
Principal Investigator
Shared Decision Making Resources