A Care Management Intervention for Non-cardiac Chest Pain

NCT04904198 | Completed

• 1 other identifier: 2017P002331
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Chest Pain

Keywords

non-cardiac chest pain; atypical chest pain; collaborative care

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• Feasibility of recruitment

  Baseline

• Feasibility of intervention attrition

  Week 8

• Feasibility of intervention safety

  Week 8

• Feasibility of data collection at baseline

  Baseline

• Feasibility of data collection at follow-up

  Week 8

Study Arms (1)

Care Management Intervention for Non-cardiac chest pain

EXPERIMENTAL

Multicomponent care management intervention.

Behavioral: Care Management Intervention for non-cardiac chest pain

Interventions

Care Management Intervention for non-cardiac chest pain BEHAVIORAL

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.

Care Management Intervention for Non-cardiac chest pain

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Jeff Huffman

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

• 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.

  PMID: 35452569 DERIVED

MeSH Terms

Conditions

Chest Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jeff C Huffman, M.D.

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Chief of Psychiatry

Study Record Dates

• First Submitted: May 18, 2021
• First Posted: May 27, 2021
• Study Start: March 22, 2019
• Primary Completion: January 8, 2020
• Study Completion: January 8, 2020
• Last Updated: May 27, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)