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

Primary Purpose

Chest Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Care Management Intervention for non-cardiac chest pain
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chest Pain focused on measuring non-cardiac chest pain, atypical chest pain, collaborative care

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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).

Sites / Locations

  • Jeff Huffman

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Care Management Intervention for Non-cardiac chest pain

Arm Description

Multicomponent care management intervention.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Feasibility of recruitment
Collect data on the proportion of individuals interested in the study who meet eligibility criteria for participation
Feasibility of intervention attrition
A priori, an attrition rate of less than or equal to 15% was defined as indicating intervention feasibility
Feasibility of intervention safety
Any adverse psychological or physical symptoms were documented throughout the study intervention with appropriate follow-up to ensure safety
Feasibility of data collection at baseline
Assessment of whether participants would be able to complete all baseline study measures
Feasibility of data collection at follow-up
Assessment of whether participants would be able to complete all follow-up study measures
Change in chest pain symptom severity
Likert scale from 0 (no pain) to 10 (severe pain)
Change in chest pain symptom frequency
Likert scale from 0 (infrequent) to 10 (very frequent)
Change in chest pain symptom impact
Likert scale from 0 (no impact) to 10 (severe impact)
Change in depressive symptoms
Patient Health Questionnaire-9, score range of 0-27, higher numbers reflect more severe symptoms.
Change in anxiety symptoms
General Anxiety Disorder-7, score range of 0-21, higher numbers reflect more severe symptoms.
Change in somatic symptom disorder/somatization symptoms
Patient Health Questionnaire-15, score range of 0-30, higher numbers reflect more severe symptoms.
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.

Full Information

First Posted
May 18, 2021
Last Updated
May 21, 2021
Sponsor
Massachusetts General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04904198
Brief Title
A Care Management Intervention for Non-cardiac Chest Pain
Acronym
NCCP
Official Title
A Care Management Intervention for Non-cardiac Chest Pain: Intervention Development and Feasibility Assessment
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
March 22, 2019 (Actual)
Primary Completion Date
January 8, 2020 (Actual)
Study Completion Date
January 8, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chest Pain
Keywords
non-cardiac chest pain, atypical chest pain, collaborative care

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Care Management Intervention for Non-cardiac chest pain
Arm Type
Experimental
Arm Description
Multicomponent care management intervention.
Intervention Type
Behavioral
Intervention Name(s)
Care Management Intervention for non-cardiac chest pain
Intervention Description
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.
Primary Outcome Measure Information:
Title
Feasibility of adherence
Description
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.
Time Frame
Week 8
Secondary Outcome Measure Information:
Title
Feasibility of recruitment
Description
Collect data on the proportion of individuals interested in the study who meet eligibility criteria for participation
Time Frame
Baseline
Title
Feasibility of intervention attrition
Description
A priori, an attrition rate of less than or equal to 15% was defined as indicating intervention feasibility
Time Frame
Week 8
Title
Feasibility of intervention safety
Description
Any adverse psychological or physical symptoms were documented throughout the study intervention with appropriate follow-up to ensure safety
Time Frame
Week 8
Title
Feasibility of data collection at baseline
Description
Assessment of whether participants would be able to complete all baseline study measures
Time Frame
Baseline
Title
Feasibility of data collection at follow-up
Description
Assessment of whether participants would be able to complete all follow-up study measures
Time Frame
Week 8
Title
Change in chest pain symptom severity
Description
Likert scale from 0 (no pain) to 10 (severe pain)
Time Frame
Change from baseline at week 8
Title
Change in chest pain symptom frequency
Description
Likert scale from 0 (infrequent) to 10 (very frequent)
Time Frame
Change from baseline at week 8
Title
Change in chest pain symptom impact
Description
Likert scale from 0 (no impact) to 10 (severe impact)
Time Frame
Change from baseline at week 8
Title
Change in depressive symptoms
Description
Patient Health Questionnaire-9, score range of 0-27, higher numbers reflect more severe symptoms.
Time Frame
Change from baseline at week 8
Title
Change in anxiety symptoms
Description
General Anxiety Disorder-7, score range of 0-21, higher numbers reflect more severe symptoms.
Time Frame
Change from baseline at week 8
Title
Change in somatic symptom disorder/somatization symptoms
Description
Patient Health Questionnaire-15, score range of 0-30, higher numbers reflect more severe symptoms.
Time Frame
Change from baseline at week 8
Title
Change in health-related quality of life
Description
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.
Time Frame
Change from baseline at week 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeff C Huffman, M.D.
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jeff Huffman
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35452569
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.
Results Reference
derived

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A Care Management Intervention for Non-cardiac Chest Pain

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