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

NCT03425266 | Completed

• 1 other identifier: 012616-019
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pain

Keywords

shared decision-making; decision support tool; patient-provider communication; managing chronic pain; patient preferences; values clarification

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  within 3 days of seeing their HCP

Secondary Outcomes (5)

• 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 Decision Self-Efficacy Scale

  immediately after viewing the intervention, 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.

Study Arms (2)

Interactive decision support tool

EXPERIMENTAL

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

Control

NO INTERVENTION

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

Interventions

Interactive decision support tool OTHER

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

Interactive decision support tool

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• chronic pain for at least 1 year.
• upcoming appointment with a referring health care provider about their chronic pain within the next 3 months.

You may not qualify if:

• 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

Sponsors & Collaborators

• Shared Decision Making Resources: lead
• University of New England: collaborator
• Pfizer: collaborator

Study Sites (1)

Shared Decision Making Resources

Georgetown, Maine, 04548, United States

Location

Related Publications (7)

• 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.

  PMID: 12900105 BACKGROUND

• Cleeland CS, Ryan KM. Pain assessment: global use of the Brief Pain Inventory. Ann Acad Med Singap. 1994 Mar;23(2):129-38.

  PMID: 8080219 BACKGROUND

• 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.

  PMID: 20551723 BACKGROUND

• 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.

  PMID: 24625035 BACKGROUND

• 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.

  PMID: 28806143 BACKGROUND

• Degner LF, Sloan JA, Venkatesh P. The Control Preferences Scale. Can J Nurs Res. 1997 Fall;29(3):21-43.

  PMID: 9505581 BACKGROUND

• 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.

  PMID: 33069228 DERIVED

MeSH Terms

Conditions

Chronic Pain; Patient Preference

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Patient Satisfaction; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Nananda F Col, MD

  Shared Decision Making Resources

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: 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.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: January 12, 2018
• First Posted: February 7, 2018
• Study Start: January 11, 2018
• Primary Completion: June 14, 2018
• Study Completion: October 31, 2018
• Last Updated: December 12, 2023

Record last verified: 2023-12

Locations

US (1)