An interventional study of Interactive decision support tool in Chronic Pain, sponsored by Shared Decision Making Resources. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-12-12.
Sponsored by Shared Decision Making Resources · Not applicable, Interventional, and Health services research
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.
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.
Phase II data analysis plan: For the RCT, the primary outcomes analyzed will be patient-provider communication (COMM), pain (PAIN), and interference (FUNCTION), all of which will be treated as continuous.
The investigators will compare Pain-APP and the control intervention. The investigators will adhere to accepted standards. Analysis will be done in 4 stages: The investigators will examine 1) whether variables meet expected distributional assumptions; 2) bivariate associations between treatment arms and each outcome, and between covariates and outcomes; 3) unadjusted measures of effect and potential confounders; 4) exploratory multivariable analyses. Patients who are lost to follow-up will be treated according to their assigned group (intent to treat analysis). The investigators will use analysis of covariance to assess differences in outcomes between assigned groups, adjusting for any baseline differences between the randomized comparison groups. Covariates will include baseline health status, moderators listed in Table 3, and prescriber characteristics. The investigators will use linear mixed-effects models, treating scores at different points in time as repeated measures to account for inter-correlation between these measurements. The investigators will control for patient- and HCP-level factors by including them as covariates.
ii) Quantify the amount of change expected: The investigators expect to find, at minimum, a 20% improvement in communication, comparing the difference in communication pre- post- intervention in the Pain-APP group to that of the control group. Power analysis: The investigators expect a mean of 70 and a SD of 20. With the proposed sample size of 50 (25 in each arm), the investigators estimate having an 80% chance of detecting a 20% improvement on the primary outcome COMM at time=T1, with a type-I error rate of 0.05.
3,227 studies on the registry are indexed under Chronic Pain; 729 are open to participants now.
This study's enrollment of 80 is above the median of 60 across 2,388 interventional studies indexed under Chronic Pain.
Browse Chronic Pain studies →Shared Decision Making Resources is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Online interactive multimedia decision support tool that the patient interacts with before seeing their provider that helps them learn more about chronic pain, identify treatment goals and preferences, and communicate more effectively with their provider. The tool takes between 20-45 minutes to use. It generates and transmits a preference summary for the patient and a summary of relevant shared decision making elements and medical history elements intended for sharing with providers if the patient chooses.
Other: Interactive decision support tool
Our control arm is a leading consumer-facing website designed for people with chronic pain (the ACPA). Subjects randomly assigned to this arm will be directed to the page focusing on communication tools, which also includes links to other parts of the website. The specific page is: https://theacpa.org/Communication-Tools
PainApp 1) assesses patient treatment goals (a structured values clarification exercise) and preferences, including decision making and communication preferences; 2) presents structured educational modules tailored to the user's stated goals and preferences; 3) presents educational information addressing identified gaps in care and communication; 4) assesses pain, pain interference, function, and other clinical factors; 5) generates succinct individualized summaries of patient treatment preferences and medical history, tailored to different clinical settings; 6) generates a personalized report for the patient, based on their goals and interests; 7) transmits the clinical summary to the patient and their provider(s), with patient permission.
Also known as: PainApp
CG CAHPS (adult, Clinician and Group Survey)
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.
Time frame: within 3 days of seeing their HCP
The 10-item satisfaction with communication subscale of the COMRADE scale
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.
Time frame: within 3 days of seeing their HCP
The Brief Pain Inventory
Self reported assessment of pain at its worst, least, average, and now, and interference of pain with 7 daily activities (walking, work, mood, enjoyment of life, relations with others, and sleep).
Time frame: immediately after viewing the intervention, just after seeing their HCP, and 1 month later.
Opioid use
Whether or not the patient is currently using an opioid medication
Time frame: just after seeing their HCP and 1 month later.
The Decision Self-Efficacy Scale
Self-efficacy will be measured using the Decision Self-Efficacy Scale and is a continuous variable. This scale measures self-confidence or belief in one's abilities in decision making, including shared decision making. The version with 5 response categories (0=not at all confident), 4=very confident) is used. All items are summed, divided by 11, then multiplied by 25. Scores range from 0 (not at all confident) to 100 (very confident). Higher scores (corresponding to more confidence) is considered to be better.
Time frame: immediately after viewing the intervention, just after seeing their HCP, and 1 month later.
The Control Preference Scale
The control preferences construct is defined as "the degree of control an individual wants to assume when decisions are being made about medical treatment." It is self-report, using 1-item question. These roles range from the individual making the treatment decisions, through the individual making the decisions jointly with the physician, to the physician making the decisions. Collaborative roles are generally considered preferable to the physician or patient making the decisions alone. The numerical scoring itself is not considered relevant; it is a categorical scale.
Time frame: immediately after viewing the intervention, just after seeing their HCP
Attitude towards opioids, drawn, in part, from Prescribed Opioids Difficulty Scale
Self-report of patient perception about opioids, using 1 items, intention to stop using or cut back using opioids, for people currently using an opioid. The study team adapted the question for those not using an opioid, ("It made me not want to use an opioid"; it helped me think about the pros and cons of opioids", and "It changed the way I think about opioids"
Time frame: immediately after viewing the intervention, just after seeing their HCP, and 1 month later.
Plan to share: Undecided — Yes, there is a plan to make individual participant data available to other researchers. It consists of a controlled access approach using a transparent and robust system to review requests and provide secure data access (reviewing all reasonable requests by our patient and clinical advisers), providing that there is adequate assurance that patient privacy and confidentiality can be maintained; and does not violate any agreements with our collaborators or sponsor organizations.
Ran from Jan 2018 to primary completion in Jun 2018, 5 months.
Of 1,295 non-industry interventional studies with no phase under Chronic Pain, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 39. This study's 5 months is below that.
Counting every sponsor, half of 1,378 studies reached it within 20 months; a quarter within 9 and three quarters within 38.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.
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