A Care Management Intervention for Non-cardiac Chest Pain

Study Overview
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Brief Summary
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The investigators developed and implemented an eight-week multicomponent care management intervention for non-cardiac chest pain. Team members including a cardiologist, nurse, and psychiatrist. Impressions and recommendations were shared with the patient's primary care physician. Measures of chest pain severity, frequency and impact and measures of psychological health and health-related quality of life were completed at baseline and intervention completion.

Detailed Description
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The investigators developed and implemented an eight-week multicomponent care management intervention for non-cardiac chest pain. The care management team consisted of a nurse, cardiologist, and psychiatrist. Following a one-time consultation visit with the cardiologist and nurse, evaluation and treatment recommendations were conveyed to the participant's primary care physician. Then, the nurse completed eight weekly phone calls with the participant to provide support, introduce therapeutic principles, and assist with coordination of care, under the supervision of a psychiatrist. Intervention feasibility was assessed on several domains including adherence, recruitment, attrition, safety, and data collection. To examine preliminary efficacy, participants completed Likert scales of chest pain symptom severity, frequency and impact, and measures of psychological health (Patient Health Questionnaire-9, General Anxiety Disorder-7, Patient Health Questionnaire-15) and health-related quality of life (12-Item Short Form Survey) at baseline and intervention completion.

Official Title
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A Care Management Intervention for Non-cardiac Chest Pain: Intervention Development and Feasibility Assessment

Conditions
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Chest Pain

Intervention / Treatment
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* Behavioral: Care Management Intervention for non-cardiac chest pain


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of non-cardiac chest pain, defined as chest pain recurring at least once per week for two weeks with at least two of the following objective tests: (1) electrocardiogram without ischemic changes; (2) negative cardiac enzymes; (3) non-ischemic cardiac stress test. Primary care physician affiliated with the institution Exclusion Criteria: History or subsequent diagnosis of cardiac disease Objectively diagnosed alternative medical etiology of chest pain (e.g., gastroesophageal disease) Resolution of chest pain prior to enrollment Cognitive impairment, assessed using a six-item screen Inability to communicate in English Lack of telephone access (precluding weekly phone call participation).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Care Management Intervention for Non-cardiac chest pain<br>Multicomponent care management intervention. | Behavioral: Care Management Intervention for non-cardiac chest pain<br>* Multicomponent eight-week care management intervention involving a consultation visit with a cardiologist and nurse. Recommendations from the consultation visit are conveyed to the primary care physician. Following the visit, the participant has eight weekly phone calls with a nurse to provide support, introduce therapeutic principals, and assess symptoms. The study nurse is supervised by a psychiatrist.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of adherence | A priori, feasible adherence was defined as 100% completion of the consultation visit and a mean completion of at least half of the eight phone calls over the eight-week study period. | Week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of recruitment | Collect data on the proportion of individuals interested in the study who meet eligibility criteria for participation | Baseline | 
| Feasibility of intervention attrition | A priori, an attrition rate of less than or equal to 15% was defined as indicating intervention feasibility | Week 8 | 
| Feasibility of intervention safety | Any adverse psychological or physical symptoms were documented throughout the study intervention with appropriate follow-up to ensure safety | Week 8 | 
| Feasibility of data collection at baseline | Assessment of whether participants would be able to complete all baseline study measures | Baseline | 
| Feasibility of data collection at follow-up | Assessment of whether participants would be able to complete all follow-up study measures | Week 8 | 
| Change in chest pain symptom severity | Likert scale from 0 (no pain) to 10 (severe pain) | Change from baseline at week 8 | 
| Change in chest pain symptom frequency | Likert scale from 0 (infrequent) to 10 (very frequent) | Change from baseline at week 8 | 
| Change in chest pain symptom impact | Likert scale from 0 (no impact) to 10 (severe impact) | Change from baseline at week 8 | 
| Change in depressive symptoms | Patient Health Questionnaire-9, score range of 0-27, higher numbers reflect more severe symptoms. | Change from baseline at week 8 | 
| Change in anxiety symptoms | General Anxiety Disorder-7, score range of 0-21, higher numbers reflect more severe symptoms. | Change from baseline at week 8 | 
| Change in somatic symptom disorder/somatization symptoms | Patient Health Questionnaire-15, score range of 0-30, higher numbers reflect more severe symptoms. | Change from baseline at week 8 | 
| Change in health-related quality of life | 12-Item Short Form Survey. Generates a physical health composite summary and a mental health composite summary. The mean score is set to 50 for each composite score. Scores > 50 indicate better physical or mental health-related quality of life than the mean, and scores < 50 indicate worse physical or mental health-related quality of life than the mean. | Change from baseline at week 8 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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non-cardiac chest pain, atypical chest pain, collaborative care