A Care Management Intervention for Non-cardiac Chest Pain
- Conditions
- Chest Pain
- Interventions
- Behavioral: Care Management Intervention for non-cardiac chest pain
- Registration Number
- NCT04904198
- Lead Sponsor
- Massachusetts General Hospital
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 3
- 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
- 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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Care Management Intervention for Non-cardiac chest pain Care Management Intervention for non-cardiac chest pain Multicomponent care management intervention.
- Primary Outcome Measures
Name Time Method Feasibility of adherence Week 8 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.
- Secondary Outcome Measures
Name Time Method Feasibility of intervention safety Week 8 Any adverse psychological or physical symptoms were documented throughout the study intervention with appropriate follow-up to ensure safety
Change in chest pain symptom frequency Change from baseline at week 8 Likert scale from 0 (infrequent) to 10 (very frequent)
Change in chest pain symptom impact Change from baseline at week 8 Likert scale from 0 (no impact) to 10 (severe impact)
Change in anxiety symptoms Change from baseline at week 8 General Anxiety Disorder-7, score range of 0-21, higher numbers reflect more severe symptoms.
Change in somatic symptom disorder/somatization symptoms Change from baseline at week 8 Patient Health Questionnaire-15, score range of 0-30, higher numbers reflect more severe symptoms.
Feasibility of intervention attrition Week 8 A priori, an attrition rate of less than or equal to 15% was defined as indicating intervention feasibility
Feasibility of data collection at follow-up Week 8 Assessment of whether participants would be able to complete all follow-up study measures
Feasibility of data collection at baseline Baseline Assessment of whether participants would be able to complete all baseline study measures
Change in chest pain symptom severity Change from baseline at week 8 Likert scale from 0 (no pain) to 10 (severe pain)
Feasibility of recruitment Baseline Collect data on the proportion of individuals interested in the study who meet eligibility criteria for participation
Change in depressive symptoms Change from baseline at week 8 Patient Health Questionnaire-9, score range of 0-27, higher numbers reflect more severe symptoms.
Change in health-related quality of life Change from baseline at week 8 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.
Trial Locations
- Locations (1)
Jeff Huffman
🇺🇸Boston, Massachusetts, United States