Clinical trial NCT02100982: Improving Communication About Patient Priorities in Multimorbidity
Official title: Developing a Customized Care Intervention to Improve Mental Health Outcomes in Multimorbidity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Disease
Keywords: Multimorbidity
Communication
Primary Care
Mental Health
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2014-04-01
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Customized Care (intervention) vs. care as usual
Primary purpose: OTHER

Brief 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.

Detailed 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

Eligibility criteria: 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

Primary outcomes:
measure: Patient-PCP communication
timeFrame: from the beginning to the end of the patient-PCP office visit, average duration of 20 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Highland Family Medicine
state: New York
Study officials:
affiliation: University of Rochester
name: Marsha N Wittink, MD, MBE
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.