The Pain App Study: A Novel Shared Decision Making Tool for People With Chronic Pain

NCT03425266

Last updated date
Study Location
Shared Decision Making Resources
Georgetown, Maine, 04548, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Chronic Pain
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

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Advanced Information
Descriptive Information
Brief Title  ICMJE The Pain App Study: A Novel Shared Decision Making Tool for People With Chronic Pain
Official Title  ICMJE Incorporating Patient Preferences Into Decisions About Chronic Pain Management (The Pain APP Study)
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.

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Participants are randomly assigned to either the new intervention (PainApp) or a website designed for people with chronic pain before an upcoming appointment with their provider.
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.
Primary Purpose: Health Services Research
Condition  ICMJE Chronic Pain
Intervention  ICMJE Other: Interactive decision support tool
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.
Other Name: PainApp
Study Arms  ICMJE
  • Experimental: Interactive decision support tool
    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.
    Intervention: Other: Interactive decision support tool
  • No Intervention: Control
    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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: February 1, 2018)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 30, 2018
Estimated Primary Completion Date February 28, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03425266
Other Study ID Numbers  ICMJE 012616-019
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD:Undecided
Plan Description:We will use 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.
Responsible Party Nananda Col, Shared Decision Making Resources
Study Sponsor  ICMJE Shared Decision Making Resources
Collaborators  ICMJE
  • University of New England
  • Pfizer
Investigators  ICMJE
Principal Investigator:Nananda F Col, MDShared Decision Making Resources
PRS Account Shared Decision Making Resources
Verification Date February 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP