A Care Management Intervention for Non-cardiac Chest Pain

Chest Pain Clinical Trial

— NCCP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04904198
• Other study ID #: 2017P002331
• Status: Completed
• Phase: N/A
• Start date: March 22, 2019
• Est. completion date: January 8, 2020

Study information

• Verified date: May 2021
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3
• Est. completion date: January 8, 2020
• Est. primary completion date: January 8, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Chest Pain

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.

Locations

Country	Name	City	State
United States	Jeff Huffman	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Feasibility of recruitment	Collect data on the proportion of individuals interested in the study who meet eligibility criteria for participation	Baseline
Secondary	Feasibility of intervention attrition	A priori, an attrition rate of less than or equal to 15% was defined as indicating intervention feasibility	Week 8
Secondary	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
Secondary	Feasibility of data collection at baseline	Assessment of whether participants would be able to complete all baseline study measures	Baseline
Secondary	Feasibility of data collection at follow-up	Assessment of whether participants would be able to complete all follow-up study measures	Week 8
Secondary	Change in chest pain symptom severity	Likert scale from 0 (no pain) to 10 (severe pain)	Change from baseline at week 8
Secondary	Change in chest pain symptom frequency	Likert scale from 0 (infrequent) to 10 (very frequent)	Change from baseline at week 8
Secondary	Change in chest pain symptom impact	Likert scale from 0 (no impact) to 10 (severe impact)	Change from baseline at week 8
Secondary	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
Secondary	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
Secondary	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
Secondary	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