Chronic DiseaseICOM-APPNCT02100982
Improving Communication About Patient Priorities in Multimorbidity
A study testing Customized Care and Care As Usual in people with Chronic Disease, run by University of Rochester at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Disease
- What is being tested?
- Customized Care and Care As Usual
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2015to 24 Apr 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- non-English speakers
- patients with a diagnosis of dementia or cognitive deficit
- patients with acute medical needs requiring urgent treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Developing a Customized Care Intervention to Improve Mental Health Outcomes in Multimorbidity
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.
Read the 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:
- To assess usability of the Customized Care components (the DPT and QPL)
- To assess feasibility of Customized Care in primary care settings
- To conduct a pilot study of the effects of Customized Care on patient-PCP communication
- Conditions
- Chronic Disease
- Being tested
- Customized Care, Care As Usual
- Keywords
- Multimorbidity, Communication, Primary Care, Mental Health
- Medical subject headings
- Chronic Disease, Communication, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Customized CareOther
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 UsualOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Care As Usual | Other | Before the office visit with the PCP, patient participants in the Care As Usual arm 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. Receives: Other: Care As Usual |
| Customized Care | Experimental | Before the office visit with the PCP, patient participants in the intervention group will interact with the computer based components of the customized care intervention while in the waiting room. The research staff will help the participant use an iPad in the waiting room and direct them to the Discussion Prioritization tool (DPT). After participants use the DPT, the program automatically generates a customized questions prompt list (QPL) which will be printed out in the office. Study staff will hand the QPL to intervention patients to bring to their office visit with the PCP. Consented patient-participants will be told that the subsequent office visit with the PCP will be audio-recorded to assess patient-PCP communication. Receives: Other: Customized Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: from the beginning to the end of the patient-PCP office visit, average duration of 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2014 (estimated)
- Study startJun 2015
- Primary completionOct 2017
- Study completion24 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Customized Care (intervention) vs. care as usual
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Marsha Wittink, University of Rochester
- Investigators
- Marsha N Wittink, MD, MBE, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02100982
- Sponsor's protocol ID
- MH101236
- Other IDs
- 5R34MH101236
- Acronym
- ICOM-APP
- Status last verified
- Apr 2018
- First submitted
- 19 Mar 2014
- Last updated
- 26 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Data will be made available on request once cleaned and initial analyses by primary team are completed.
Publications
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.
PubMed 28191546Wittink 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.
PubMed 28844522
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing a Customized Care Intervention to Improve Mental Health Outcomes in Multimorbidity
- ClinicalTrials.gov ID
- NCT02100982
- Acronym / sponsor ID
- ICOM-APP / MH101236
- Conditions
- Chronic Disease
- Keywords
- Multimorbidity, Communication, Primary Care, Mental Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Jun 2015
- Primary completion
- Oct 2017 (actual)
- Study completion
- 24 Apr 2018 (actual)
- First posted
- 1 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To assess usability of the Customized Care components (the DPT and QPL)
- To assess feasibility of Customized Care in primary care settings
- To conduct a pilot study of the effects of Customized Care on patient-PCP communication
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Customized Care (intervention) vs. care as usual
| Arm | Type | Receives |
|---|---|---|
| Care As Usual | Other | Other: Care As UsualBefore the office visit with the PCP, patient participants in the Care As Usual arm 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. |
| Customized Care | Experimental | Other: Customized CareBefore the office visit with the PCP, patient participants in the intervention group will interact with the computer based components of the customized care intervention while in the waiting room. The research staff will help the participant use an iPad in the waiting room and direct them to the Discussion Prioritization tool (DPT). After participants use the DPT, the program automatically generates a customized questions prompt list (QPL) which will be printed out in the office. Study staff will hand the QPL to intervention patients to bring to their office visit with the PCP. Consented patient-participants will be told that the subsequent office visit with the PCP will be audio-recorded to assess patient-PCP communication. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- non-English speakers
- patients with a diagnosis of dementia or cognitive deficit
- patients with acute medical needs requiring urgent treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Customized CareCustomized 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. | Other | Customized Care |
| Care As UsualParticipants 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. | Other | Care As Usual |
Primary outcome
Patient-PCP communication
Time frame: from the beginning to the end of the patient-PCP office visit, average duration of 20 minutes
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2018.
- Background: PubMed 28191546Wittink 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.
- Background: PubMed 28844522Wittink 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.
- Individual participant dataSharing planned: Yes. Data will be made available on request once cleaned and initial analyses by primary team are completed.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marsha N Wittink, MD, MBE principal investigator
University of Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Customized Care and Care As Usual in people with Chronic Disease, run by University of Rochester at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient-PCP communication (time frame: from the beginning to the end of the patient-PCP office visit, average duration of 20 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02100982, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2018.