Clinical trial NCT03425266: The Pain App Study: A Novel Shared Decision Making Tool for People With Chronic Pain
Official title: Incorporating Patient Preferences Into Decisions About Chronic Pain Management (The Pain APP Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Keywords: shared decision-making
decision support tool
patient-provider communication
managing chronic pain
patient preferences
values clarification
Lead sponsor: Shared Decision Making Resources
Sponsor class: OTHER
Collaborators: name: University of New England
name: Pfizer
First posted: 2018-02-07
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: CG CAHPS (adult, Clinician and Group Survey)
timeFrame: within 3 days of seeing their HCP
measure: The 10-item satisfaction with communication subscale of the COMRADE scale
timeFrame: within 3 days of seeing their HCP
Secondary outcomes:
measure: The Brief Pain Inventory
timeFrame: immediately after viewing the intervention, just after seeing their HCP, and 1 month later.
measure: Opioid use
timeFrame: just after seeing their HCP and 1 month later.
measure: The Decision Self-Efficacy Scale
timeFrame: immediately after viewing the intervention, just after seeing their HCP, and 1 month later.
measure: The Control Preference Scale
timeFrame: immediately after viewing the intervention, just after seeing their HCP
measure: Attitude towards opioids, drawn, in part, from Prescribed Opioids Difficulty Scale
timeFrame: immediately after viewing the intervention, just after seeing their HCP, and 1 month later.
Other outcomes:
Locations:
city: Georgetown
country: United States
facility: Shared Decision Making Resources
state: Maine
Study officials:
affiliation: Shared Decision Making Resources
name: Nananda F Col, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Edwards A, Elwyn G, Hood K, Robling M, Atwell C, Holmes-Rovner M, Kinnersley P, Houston H, Russell I. The development of COMRADE--a patient-based outcome measure to evaluate the effectiveness of risk communication and treatment decision making in consultations. Patient Educ Couns. 2003 Jul;50(3):311-22. doi: 10.1016/s0738-3991(03)00055-7.
citation: Cleeland CS, Ryan KM. Pain assessment: global use of the Brief Pain Inventory. Ann Acad Med Singap. 1994 Mar;23(2):129-38.
citation: Banta-Green CJ, Von Korff M, Sullivan MD, Merrill JO, Doyle SR, Saunders K. The prescribed opioids difficulties scale: a patient-centered assessment of problems and concerns. Clin J Pain. 2010 Jul-Aug;26(6):489-97. doi: 10.1097/AJP.0b013e3181e103d9.
citation: Sepucha KR, Borkhoff CM, Lally J, Levin CA, Matlock DD, Ng CJ, Ropka ME, Stacey D, Joseph-Williams N, Wills CE, Thomson R. Establishing the effectiveness of patient decision aids: key constructs and measurement instruments. BMC Med Inform Decis Mak. 2013;13 Suppl 2(Suppl 2):S12. doi: 10.1186/1472-6947-13-S2-S12. Epub 2013 Nov 29.
citation: Col NF, Solomon AJ, Springmann V, Garbin CP, Ionete C, Pbert L, Alvarez E, Tierman B, Hopson A, Kutz C, Berrios Morales I, Griffin C, Phillips G, Ngo LH. Whose Preferences Matter? A Patient-Centered Approach for Eliciting Treatment Goals. Med Decis Making. 2018 Jan;38(1):44-55. doi: 10.1177/0272989X17724434. Epub 2017 Aug 14.
citation: Degner LF, Sloan JA, Venkatesh P. The Control Preferences Scale. Can J Nurs Res. 1997 Fall;29(3):21-43.
citation: Col N, Hull S, Springmann V, Ngo L, Merritt E, Gold S, Sprintz M, Genova N, Nesin N, Tierman B, Sanfilippo F, Entel R, Pbert L. Improving patient-provider communication about chronic pain: development and feasibility testing of a shared decision-making tool. BMC Med Inform Decis Mak. 2020 Oct 17;20(1):267. doi: 10.1186/s12911-020-01279-8.