Jeff Huffman
Boston, Massachusetts, 02114, United States
NCT Number: NCT04904198
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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Notify Me18 year and older
All sexes
Interventional
Not applicable
Boston, Massachusetts, 02114, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: Baseline
Collect data on the proportion of individuals interested in the study who meet eligibility criteria for participation
Time frame: Week 8
A priori, an attrition rate of less than or equal to 15% was defined as indicating intervention feasibility
Time frame: Week 8
Any adverse psychological or physical symptoms were documented throughout the study intervention with appropriate follow-up to ensure safety
Time frame: Baseline
Assessment of whether participants would be able to complete all baseline study measures
Time frame: Week 8
Assessment of whether participants would be able to complete all follow-up study measures
Time frame: Change from baseline at week 8
Likert scale from 0 (no pain) to 10 (severe pain)
Time frame: Change from baseline at week 8
Likert scale from 0 (infrequent) to 10 (very frequent)
Time frame: Change from baseline at week 8
Likert scale from 0 (no impact) to 10 (severe impact)
Time frame: Change from baseline at week 8
Patient Health Questionnaire-9, score range of 0-27, higher numbers reflect more severe symptoms.
Time frame: Change from baseline at week 8
General Anxiety Disorder-7, score range of 0-21, higher numbers reflect more severe symptoms.
Time frame: Change from baseline at week 8
Patient Health Questionnaire-15, score range of 0-30, higher numbers reflect more severe symptoms.
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.
Massachusetts General Hospital
Other
A Care Management Intervention for Non-cardiac Chest Pain: Intervention Development and Feasibility Assessment
Acronym: NCCP
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