A Care Management Intervention for Non-cardiac Chest Pain (NCCP)

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

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.

Study Overview

• Status: Completed
• Conditions: Chest Pain
• Intervention / Treatment: Behavioral: Care Management Intervention for non-cardiac chest pain

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.

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Jeff Huffman

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Care Management Intervention for Non-cardiac chest pain; Multicomponent care management intervention.

Behavioral: Care Management Intervention for non-cardiac chest pain; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Investigators: Principal Investigator: Jeff C Huffman, M.D., Massachusetts General Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 22, 2019
• Primary Completion (Actual): January 8, 2020
• Study Completion (Actual): January 8, 2020

Study Registration Dates

• First Submitted: May 18, 2021
• First Submitted That Met QC Criteria: May 21, 2021
• First Posted (Actual): May 27, 2021

Study Record Updates

• Last Update Posted (Actual): May 27, 2021
• Last Update Submitted That Met QC Criteria: May 21, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: collaborative care; non-cardiac chest pain; atypical chest pain
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chest Pain
• Other Study ID Numbers: 2017P002331

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No