Enhancing Geriatric Pain Care

Pain Clinical Trial

Official title:

Enhancing Geriatric Pain Care With Contextual Patient Generated Data Profiles

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04560920
• Other study ID #: IIR 19-265
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2023
• Est. completion date: September 30, 2024

Study information

• Verified date: April 2024
• Source: VA Office of Research and Development
• Contact: Jorie Butler, PhD
• Phone: (801) 582-1565
• Email: Jorie.Butler[@]va.gov
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This project is focused on Veteran patients 65 and older with chronic pain. In this project, the investigators will understand the impact of a contextual patient generated data (PGD). Contextual PGD are data about what is important to patients, information about the Veterans social and home contexts (for example, how the Veterans medications are stored and how much help they receive from others). In this study the investigators will talk with Veterans with chronic pain and the Veterans informal caregivers (family members or friends who help them) and find out about how they are coping with chronic pain and what information might be helpful to provide to the Veterans healthcare team. Then, the investigators will talk to clinicians about information that might be helpful to them. The investigators will collect contextual PGD and use it to develop a computer application for collecting contextual PGD and displaying it to patients and doctors in a visit. The investigators will also test the impact of having contextual PGD in a visit on patient satisfaction with the Veterans care plan and how well they are able to follow the care plan.

Description:

The investigators proposal addresses the use of patient generated data (PGD) - an innovative approach to deliver patient centered care to older Veterans that is characterized by attention to patient priorities, values, and goals. The investigators clinical focus is on chronic pain in older Veterans, which is widespread. PGD broadly encompasses many sources and types of data. The investigators will categorize contextual PGD into 3 core components 1) relational PGD (patient-clinician relationship and patient individual differences such as pain catastrophizing) 2) whole person PGD (what matters to the patient including patient preferences), and 3) behavioral PGD (pain self-efficacy and patient actions related to health , pain management, functional status). The investigators study is mixed methods.

In aim 1 the investigators will: Prioritize content for contextual PGD profile displays to support patient centered care for geriatric Veterans with chronic pain. The investigators will conduct focus groups with geriatric Veterans with chronic pain and the Veterans caregivers to explore Veterans' perspectives on the content of the PGD profile displays and the Veterans attitudes toward them. The investigators will conduct focus groups with clinicians about desired content of the PGD profile displays specific to pain management. The investigators will iteratively prioritize PGD elements in accordance with pain care management needs of geriatric patients, incorporating results of a card sort exercise performed by clinicians.

In aim 2 the investigators will :Develop a prototype contextual PGD profile display and evaluate its usability. The investigators will develop a prototype clinician-facing PGD profile display containing PGD elements and guides to interpretation/use for clinicians. The investigators will refine the PGD profile display prototype with clinicians in user-centered design sessions. The investigators will broadly assess usability in a simulation study with primary care clinicians.

In aim 3 the investigators will: Examine the impact of contextual PGD profile displays on patient adherence, pain function, satisfaction, and shared decision making in a randomized trial. The investigators will evaluate operationalization of the pain care plan and the shared decision making process in the visit by coding study visit recordings. The investigators will assess the impact of contextual PGD by comparing patient adherence to pain care regimens, pain function, patient satisfaction, and shared decision making process for a sample of 150 geriatric patients with chronic pain in VA primary care clinics. The investigators will compare between-subjects visits that include access to contextual PGD profile displays to visits without access.

The investigators primary hypothesis is that access to contextual PGD profile displays during a clinical visit will result in better adherence to the pain care plan at 30 days, compared with no PGD profile display.

Throughout the project the investigators will work with stakeholders in clinic settings and implementation of the electronic health record to ensure future implementation can be optimized.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: September 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years to 89 Years

Eligibility

Inclusion Criteria:

• Clinicians are eligible if they are a primary care clinician or PACT member

• including physicians, nurse practitioners, nurses, social workers, pharmacists, and psychologists for Veteran patients over age 65 diagnosed with chronic pain in primary care, geriatrics clinic, or a local or rural CBOC within the Salt Lake City catchment.

Eligible VHA patients will be age 65 and older with a diagnosis of chronic pain defined by ICD 10 codes. Veteran caregivers (including spouses, other relatives, or close friends involved in the daily life of the Veteran) will also be eligible for participation in this study. Vulnerable populations, women, and minorities are eligible to the extent that they are represented in the above described population or are a caregiver.

Exclusion Criteria:

• Veterans who need a legally authorized representative to consent.

Related Conditions & MeSH terms

• Pain

Intervention

Other:
• Availability of contextual PGD at the visit
Contextual PGD will be availability in a display at the visit.

Locations

Country	Name	City	State
United States	VA Salt Lake City Health Care System, Salt Lake City, UT	Salt Lake City	Utah

Sponsors (2)

Lead Sponsor	Collaborator
VA Office of Research and Development	University of Utah

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adherence to the Pain Care Plan	MOS General Adherence Scale-Participants rate adherence on a 1-5 scale with higher scores indicating better adherence	Between 2 years and 4.5 years after study start
Secondary	Patient Satisfaction with the Visit	SHEP communication scale, 4 items used to assess satisfaction with visit communication	1.5 years to 4 years after study start
Secondary	Shared Decision Making in the Visit	Participatory Decision making style questionnaire, used in Medical Outcomes Study and relates to satisfaction with care. Participants rate participation on a 1-5 scale with higher scores indicating higher participation	1.5 years to 4 years after study start
Secondary	Shared Decision Making in the visit	OPTION coding, a standardized coding scheme to capture shared decision making in the visit.	1.5 years to 4 years after study start
Secondary	Pain Function	West Haven Yale Multidimensional Pain Inventory (WHYMPI). WHYMPI Statements are rated on a 0-6 Likert scale with higher scores indicating higher intensity	Between 2 years and 4.5 years after study start
Secondary	Patient perspective of Shared Decision Making	OPACIC adapted for older adults from the Patient Assessment of Chronic Illness Scale. This measure includes 5 subscales, patient activation, deliver system design/decision support, goal setting and tailoring, and follow-up/coordination. OPACIC statements are rated on a 1-5 Likert scale with higher scores indicating higher intensity	Between 2 years and 4.5 years after study start