Clinical trial NCT04904198: A Care Management Intervention for Non-cardiac Chest Pain
Official title: A Care Management Intervention for Non-cardiac Chest Pain: Intervention Development and Feasibility Assessment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chest Pain
Keywords: non-cardiac chest pain
atypical chest pain
collaborative care
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2021-05-27
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Feasibility of adherence
timeFrame: Week 8
Secondary outcomes:
measure: Feasibility of recruitment
timeFrame: Baseline
measure: Feasibility of intervention attrition
timeFrame: Week 8
measure: Feasibility of intervention safety
timeFrame: Week 8
measure: Feasibility of data collection at baseline
timeFrame: Baseline
measure: Feasibility of data collection at follow-up
timeFrame: Week 8
measure: Change in chest pain symptom severity
timeFrame: Change from baseline at week 8
measure: Change in chest pain symptom frequency
timeFrame: Change from baseline at week 8
measure: Change in chest pain symptom impact
timeFrame: Change from baseline at week 8
measure: Change in depressive symptoms
timeFrame: Change from baseline at week 8
measure: Change in anxiety symptoms
timeFrame: Change from baseline at week 8
measure: Change in somatic symptom disorder/somatization symptoms
timeFrame: Change from baseline at week 8
measure: Change in health-related quality of life
timeFrame: Change from baseline at week 8
Other outcomes:
Locations:
city: Boston
country: United States
facility: Jeff Huffman
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Jeff C Huffman, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Madva EN, Celano CM, Kim S, Bell M, Radfar A, Ibrahim NE, Dar T, Albanese A, Tawakol A, Huffman JC. A Care Management Intervention for Noncardiac Chest Pain: Treatment Development and Feasibility Assessment. Prim Care Companion CNS Disord. 2022 Apr 19;24(2):21m03045. doi: 10.4088/PCC.21m03045.