Sunday, June 8, 2025
6/8/2025
COPE-P: SHARED DECISION-MAKING AID FOR PATIENTS REGARDING CHRONIC OPIOID THERAPY - DESCRIPTION (provided by applicant): Use of prescription opioids for chronic non-cancer pain (CNCP) has escalated rapidly in the past two decades. Prescription opioid abuse is the fastest growing form of drug abuse, and prescription opioids are now the top cause of accidental drug overdose. The FDA plans to issue a Risk Evaluation and Mitigation Strategy to manage risks associated with chronic opioid therapy (COT),underscoring the urgent need for new strategies to assure quality pain care while limiting opioid abuse and related harms. Specifically, both clinicians and patients need help in resolving uncertainty when facing clinical decisions about COT in a manner that improves care and preserves the therapeutic relationship. Shared decision making (SDM) is an important means to respect patient autonomy and enhance collaboration in the therapeutic relationship. It can also be an effective means to address irrational practice variation and to reduce inappropriate health care utilization. We propose to develop COPE-P: Collaborative Opioid Prescribing Education for Patients, a web-based tutorial and decision aid for candidates for COT to facilitate SDM about whether to initiate, modify, or continue COT. This proposal is innovative because there has been little use of patient-oriented SDM decision aids for medication decisions specifically to reduce risks of substance abuse. COPE-P will be an important component of a suite of three products to help manage the risks of COT in primary care. Two related products, COPE (for prescribing providers) and COPE-N (for nurse care managers), are funded by other grants and in ongoing development. In Phase I, we will: 1) conduct a focus group with N=9 CNCP patients prior to development of COPE-P to elicit qualitative data on CNCP patients' concerns, expectancies, values, and beliefs regarding COT; 2) develop Chapter 1 of COPE-P consisting of balanced, understandable, personalized, and evidence-based information about the role of COT in CNCP treatment including Adobe Flash-based graphics to illustrate core concepts relevant to COT decisions and interactive exercises; 3) develop Chapter 2 of COPE-P concerning elicitation of personal attitudes, goals, and values relevant to core COT-related patient decision points to enhance the patient's motivation to participate in SDM; 4) outline Chapter 3 guiding patients in deliberation and communication skills to facilitate participation in SDM and assist negotiation of goals for COT treatment; 5) conduct two rounds of focus group testing (N=9 each round) during development to elicit CNCP patient feedback and incorporate indicated changes and suggestions; 6) conduct usability testing with N=6 CNCP patients and make any indicated changes; and 7) pilot test COPE-P with N=30 CNCP patients to demonstrate feasibility and acceptability and estimate its effect size on patient activation, knowledge and attitudes towards COT and SDM. In Phase II, we propose to revise COPE-P educational material, decision-making exercises, and assessments; complete development of an integrated COPE performance support system to support integration of the suite of COPE trainings (COPE, COPE-N, COPE-P); add modules for specific painful chronic diseases and for "booster sessions,: and conduct a randomized trial to evaluate COPE-P in a variety of primary care and specialty clinical settings. PUBLIC HEALTH RELEVANCE: Although they are increasingly used to treat chronic pain, prescription opioids such as Vicodin and OxyContin are now the drugs most commonly linked to accidental overdose and prescription drug abuse. New strategies are urgently needed to limit opioid abuse yet maintain quality pain care. We propose to develop a web-based program to help patients, along with their healthcare teams, learn about and decide whether to utilize chronic opioid therapy or other alternatives.
HHS’ Tracking Accountability in Government Grants System (TAGGS) website provides access to detailed descriptions of grants, loans, aggregated direct payments and other types of financial assistance awarded by the HHS Operating Divisions (OPDIVs) and the Office of the Secretary Staff Divisions (STAFFDIVs).