Improving Communication About Patient Priorities in Multimorbidity

Chronic Disease Clinical Trial

— ICOM-APP  

Official title:

Developing a Customized Care Intervention to Improve Mental Health Outcomes in Multimorbidity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02100982
• Other study ID #: MH101236
• Secondary ID: 5R34MH101236
• Status: Completed
• Phase: N/A
• First received: March 19, 2014
• Last updated: April 24, 2018
• Start date: June 2015
• Est. completion date: April 24, 2018

Study information

• Verified date: April 2018
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this study is to develop and test Customized Care, an intervention to help patients dealing with depression and/or anxiety in the context of multiple chronic conditions. Customized Care is designed to help patients communicate about important issues, such as financial and safety concerns, with their primary care providers (PCPs). The intervention will be delivered in patient waiting rooms prior to a routine follow-up visit with the PCP. Phase 1 of the project will ensure that the main components of Customized Care are acceptable to patients and PCPs. Phase 2 will include a pilot study to test the effects of Customized Care on patient-PCP communication.

Participants aged 40 years or older who have a diagnosis of two or more common chronic medical conditions will be recruited from primary care clinics. Patients screening positive for either depression or anxiety will be randomized to Customized Care vs. an active control.

The investigators hypothesize that the Customized Care will improve patient-Primary Care-Provider communication.

Description:

Patients with depression or anxiety in the context of multimorbidity (2 or more chronic conditions such as Diabetes, Heart Disease, Arthritis, COPD, Asthma) are often preoccupied with day-to-day concerns related to issues such as finances, safety and functional ability. Determining which issues to discuss, and when to discuss it, is always difficult in the 15-minute primary care visit, but it is especially challenging when patients have multiple diagnoses, symptoms and concerns.

In this application the investigators will develop and test the feasibility of Customized Care, an intervention that capitalizes on decision technology and will be deployed in primary care waiting rooms. The investigators will assess whether customized care will improve outcomes among patients with depression and/or anxiety in the context of multimorbidity. Customized Care consists of two different components designed to improve health outcomes by improving patient-provider communication. The first component is a computer-based discussion prioritization tool (DPT). The DPT forces patients to make trade-offs between competing concerns to help them determine which are the most important to discuss. The second component is a customized question prompt list (QPL) to help patients communicate their priorities to the PCP. The QPL will be generated after patients use the DPT, and consists of question prompts tailored to the patients' priorities.

When patients express their day-to-day concerns, and PCPs become aware of these concerns, the patient-provider alliance can deepen. In addition, patient motivation (perceived autonomy, competence) to manage those everyday concerns and engage in care for chronic disease and associated mental health conditions will increase. This project will lay the ground work for a larger randomized trial to assess whether customized care can improve mental health outcomes among patients with multimorbidity.

The specific aims are:

1. To assess usability of the Customized Care components (the DPT and QPL)

2. To assess feasibility of Customized Care in primary care settings

3. To conduct a pilot study of the effects of Customized Care on patient-PCP communication

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 24, 2018
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

• patients attending a primary care clinic for routine follow-up care

• age 40 or older

• diagnosed with 2 or more chronic medical conditions including: diabetes, heart disease, arthritis, asthma, COPD

• positive screen for symptoms of depression and/or anxiety

Exclusion Criteria:

• non-English speakers

• patients with a diagnosis of dementia or cognitive deficit

• patients with acute medical needs requiring urgent treatment

Related Conditions & MeSH terms

• Chronic Disease

Intervention

Other:
• Customized Care
Customized Care consists of two components. The first component is a Discussion Prioritization Tool (DPT) which forces patients to make trade-offs between competing concerns to help them determine which are the most important to discuss. The second component is a customized question prompt list (QPL) to help patients communicate their priorities to the PCP. The QPL will be generated after patients use the DPT, and consists of question prompts tailored to the patients' priorities. Consented patient-participants will be told that the subsequent office visit with the PCP will be audio-recorded to assess patient-PCP communication.
• Care As Usual
Participants in this condition will interact with the research staff who will help the participant use an iPad in the waiting room to complete baseline health assessments. Consented patient-participants will be told that the subsequent office visit with the PCP will be audio-recorded to assess patient-PCP communication.

Locations

Country	Name	City	State
United States	Highland Family Medicine	Rochester	New York

Sponsors (2)

Lead Sponsor	Collaborator
University of Rochester	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

References & Publications (2)

Wittink MN, Walsh P, Yilmaz S, Mendoza M, Street RL Jr., Chapman BP, Duberstein P. Patient priorities and the doorknob phenomenon in primary care: Can technology improve disclosure of patient stressors? Patient Educ Couns. 2018 Feb;101(2):214-220. doi: 10.1016/j.pec.2017.08.004. Epub 2017 Aug 8. — View Citation

Wittink MN, Yilmaz S, Walsh P, Chapman B, Duberstein P. Customized Care: An intervention to Improve Communication and health outcomes in multimorbidity. Contemp Clin Trials Commun. 2016 Dec 15;4:214-221. doi: 10.1016/j.conctc.2016.10.002. Epub 2016 Oct 11. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient-PCP communication	After the patient completes the experimental or active comparator intervention on the iPad, the patient will proceed with their office visit. The subsequent conversations between the patient and PCP will be audio-recorded and transcribed. We will use a coding scheme to measure communication during the patient-PCP office visit.	from the beginning to the end of the patient-PCP office visit, average duration of 20 minutes