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Completed

NCT Number: NCT04904198

A Care Management Intervention for Non-cardiac Chest Pain

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jeff Huffman

Boston, Massachusetts, 02114, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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.

Primary outcomes

  1. Feasibility of adherence

    Time frame: 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 outcomes

  1. Feasibility of recruitment

    Time frame: Baseline

    Collect data on the proportion of individuals interested in the study who meet eligibility criteria for participation

  2. Feasibility of intervention attrition

    Time frame: Week 8

    A priori, an attrition rate of less than or equal to 15% was defined as indicating intervention feasibility

  3. Feasibility of intervention safety

    Time frame: Week 8

    Any adverse psychological or physical symptoms were documented throughout the study intervention with appropriate follow-up to ensure safety

  4. Feasibility of data collection at baseline

    Time frame: Baseline

    Assessment of whether participants would be able to complete all baseline study measures

  5. Feasibility of data collection at follow-up

    Time frame: Week 8

    Assessment of whether participants would be able to complete all follow-up study measures

  6. Change in chest pain symptom severity

    Time frame: Change from baseline at week 8

    Likert scale from 0 (no pain) to 10 (severe pain)

  7. Change in chest pain symptom frequency

    Time frame: Change from baseline at week 8

    Likert scale from 0 (infrequent) to 10 (very frequent)

  8. Change in chest pain symptom impact

    Time frame: Change from baseline at week 8

    Likert scale from 0 (no impact) to 10 (severe impact)

  9. Change in depressive symptoms

    Time frame: Change from baseline at week 8

    Patient Health Questionnaire-9, score range of 0-27, higher numbers reflect more severe symptoms.

  10. Change in anxiety symptoms

    Time frame: Change from baseline at week 8

    General Anxiety Disorder-7, score range of 0-21, higher numbers reflect more severe symptoms.

  11. Change in somatic symptom disorder/somatization symptoms

    Time frame: Change from baseline at week 8

    Patient Health Questionnaire-15, score range of 0-30, higher numbers reflect more severe symptoms.

  12. Change in health-related quality of life

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Official study title

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

Acronym: NCCP

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
May 27, 2021
Registry last updated
May 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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