Enhanced Care Planning for Patients With Multiple Chronic Conditions
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|ClinicalTrials.gov Identifier: NCT03885401|
Recruitment Status : Recruiting
First Posted : March 21, 2019
Last Update Posted : October 9, 2020
|Condition or disease||Intervention/treatment||Phase|
|Multiple Chronic Conditions Health Behavior Mental Health Social Determinants of Health||Behavioral: Enhanced care planning||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||600 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||This study is a clinician level randomized controlled trial. Sixty clinicians will be randomized to intervention (enhanced care planning for health behaviors, mental health, and social needs) or control condition (usual care). The investigators will randomly survey all patients with MCC from each clinicians' patient panel. Patients with at least one uncontrolled MCC will be randomly selected for inclusion until 10 patients are recruited from each clinician. The investigators will use hybrid implementation-effectiveness design to measure outcomes. Implementation outcomes include enhanced care plan completion; the prevalence of health behavior, mental health, and social needs; goals patients prioritize and how they want to address them; and the type, intensity, and follow-up of care team support provided to address patient goals. Effectiveness outcomes include the number of uncontrolled chronic conditions and patient reported physical, mental, and social health..|
|Masking:||Single (Outcomes Assessor)|
|Masking Description:||It is not possible to blind clinicians, patients, or patient navigators. Outcomes assessors (e.g. chart abstractors, database managers, and the researchers) will be blinded to condition when abstracting, entering, or assessing data.|
|Official Title:||Enhanced Care Planning and Clinical-Community Linkages to Comprehensively Address the Basic Needs of Patients With Multiple Chronic Conditions|
|Actual Study Start Date :||September 20, 2020|
|Estimated Primary Completion Date :||August 2023|
|Estimated Study Completion Date :||August 2024|
Experimental: Enhanced care planning
The intervention consists of two components - enhanced care planning and clinical-community linkages. The enhanced care plan is created using MOHR (https://myownhealthreport.org). MOHR screens patients for unhealthy behaviors, mental health needs, and social needs. Patients identify the needs they would like to address and create a care plan, which they update quarterly. A clinical navigator and community health worker (CHW) help patients address their care plans using clinical-community linkages, which has four components. First, clinicians and clinical navigators have a resource registry identifying community programs and support - No Wrong Door (NWD) and https://navigator.aafp.org/. Second, MOHR shares information (care plans, patient narrative, and patient progress) across clinical and community team members. Third, MOHR supports messaging and video visits for team members and patients. Finally, MOHR sends care team members quarterly patient progress updates.
Behavioral: Enhanced care planning
The intervention includes (1) screening for unhealthy behaviors, mental health needs, and social needs, (2) creation of a care plan, (3) quarterly updates to the plan, (4) a clinical navigator and community health worker to support accomplishing the care plan, (5) registry of community resources and programs, and (6) messaging and video-visit system for team members.
No Intervention: Usual medical care
Clinicians randomized to the control condition will continue to provide "usual care." This includes current non-systematic assessment of health behaviors, mental health needs, and social needs. Neither clinicians nor patients will be eligible to receive CHW support or have access to NWD. Clinicians may refer some control patients to community programs as part of their current usual care. Control clinicians will be blinded as to which patients are included in the study. At the end of the study, the investigators will share with control clinicians our lessons learned, access to MOHR, and lists of useful community resources.
- Enhanced care plan creation (implementation outcome) [ Time Frame: Within 6 months of enrollment ]This outcome reports the percent of intervention patients who complete the creation of an enhanced care plan (numerator = intervention patients who create an enhanced care plan / denominator = all enrolled intervention patients).
- Health behavior, mental health, and social needs [ Time Frame: Within 6 months of enrollment ]This outcome will measure the number of health behavior, mental health, and social needs that patients have who complete an enhanced care plan. This is a frequency count of each specific need based on the health risk assessment output.
- Referral to and connection to community resources (implementation outcome) [ Time Frame: Over 2 years after enrollment ]This outcome will measure which community resources intervention patients are referred to for assistance with addressing health behaviors, mental health, and social needs. This is a frequency count of the number of intervention patients referred to each potential community resource.
- Effectiveness - chronic condition control [ Time Frame: 6 months after creating a care plan ]Percent of patients with an uncontrolled chronic condition for intervention patients versus usual care
- Maintenance - chronic condition control [ Time Frame: 2 years after creating a care plan ]Percent of patients with an uncontrolled chronic condition for intervention patients versus usual care
- Effectiveness - quality of life: Patient Reported Outcomes Measurement Information System (PROMIS-29) [ Time Frame: 6 months after creating a care plan ]Pre-post change in eight Patient Reported Outcomes Measurement Information System (PROMIS-29) domains for intervention patients versus usual care. Norm-based scores will be calculated for each domain on the PROMIS measures, so that a score of 50 represents the mean or average of the reference population. A score of 60 means that the person is one standard deviation above the reference population. Higher scores means that the patient is reporting greater symptoms. Scores will be calculated using the Healthmeasures Scoring Service (http://www.healthmeasures.net/score-and-interpret/calculate-scores).
- Maintenance - quality of life: eight PROMIS-29 domains [ Time Frame: 2 years after creating a care plan ]Pre-post change in eight PROMIS-29 domains for intervention patients versus usual care
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03885401
|Contact: Alex H Krist, MD MPHfirstname.lastname@example.org|
|Contact: Paulette Lail-Kashiri, MPHemail@example.com|
|United States, Virginia|
|Virginia Commonwealth University||Recruiting|
|Richmond, Virginia, United States, 23219|
|Contact: Alex Krist, MD 804-828-9626 firstname.lastname@example.org|
|Contact: Paulette Kashiri 8048276750 email@example.com|
|Principal Investigator: Alex Krist, MD|
|Sub-Investigator: Jennifer Hinesley, PhD|
|Principal Investigator:||Alex H Krist, MD MPH||Virginia Commonwealth University|