PAIN-HF: Pain Assessment, Incidence & Nature in Heart Failure

Sponsor

PC-HEART (Other)

Overall Status

Completed

CT.gov ID

NCT00444301

Collaborator

Mayday Fund (Other), National Institute on Aging (NIA) (NIH)

349

Enrollment

Locations

Duration (Months)

24.9

Patients Per Site

1.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Heart failure, a chronic illness afflicting 5 million persons in the United States is known to cause shortness of breath and fatigue, yet at least half of persons with heart failure also report the presence of pain.

The cause of pain for these persons is not clear. PAIN-HF (Pain Assessment, Incidence & Nature in Heart Failure), conducted through the Palliative Care-Heart Failure Education And Research Trials (PC-HEART) collaborative will identify the prevalence of pain, its location, severity and impact on activities and the possible causes of pain in persons living with heart failure. The study will also try to understand relationships between other problems and pain, as well as what treatments are given to reduce pain.

Understanding sources of pain and its characteristics is the first step in helping health care providers better manage pain and related problems in persons with heart failure.

Condition or Disease	Intervention/Treatment	Phase
Heart Diseases

Detailed Description

Subjects will be recruited via physicians and nurses providing their care in clinical sites who are members of PC-HEART. PC-HEART is a volunteer collaborative with clinician-investigators at 60 sites nationally that include hospice organizations and heart failure providers in academic, Health Maintenance Organization (HMO) and community settings. Our goal will be to enroll 400 patients with 135 in hospice care and 265 in outpatient settings (a mix of HMO, community practice, VA, and academic centers) who are members of the Palliative Care- Heart Failure Education And Research Trials (PC-HEART) collaborative. We will strive for broad representation of patients living in the community with about one-third African American patients (who often present for initial treatment with advanced heart failure) and at least one-half elderly (who have high prevalence of both pain and heart failure).

We will use standardized tools to survey patients, as follows:

Pain & other symptoms (Assessed at enrollment and one-two weeks later):

Memorial Symptom Assessment Scale- HF (MSAS-HF) Short-form McGill pain questionnaire (SF-MPQ) Brief Pain Inventory (BPI)

Heart-failure specific measures (Assessed at Enrollment):

Kansas City Cardiomyopathy Questionnaire (KCCQ)

Psycho-social situation & cognitive function (Assessed at Enrollment):

Physicians Health Questionnaire depression screen (PHQ-9) Mini-cog Social functioning:

ENRICHD Social Support Inventory (ESSI) , The Short Physical Performance Battery (SPPB) will be collected on 1/2 of subjects Clinical Data (from medical record) Patient's medical condition: Charleson Comorbidity Scale, prior diagnosis of Diabetes Mellitus, Cancer, Chronic lung disease, Coronary Artery Disease, Cirrhosis.

Known painful conditions (osteoarthritis, chronic back pain, CAD with angina, neuropathy, others) Physical examination: Jugular Venous Pressure (as per NIH trial standards: base of neck, ½ way up, jaw level), edema (+1 (0-1/4" depression), +2 (1/4-1/2"), +3 (1/2-1"), +4 (>1")), Blood pressure, Respiratory rate, Heart rate & rhythm Echocardiogram data: Date of most recent Echocardiogram, LVEF, LVDD, LA dimension, presence of valvular disease & measure of severity (for example, if aortic stenosis then valve area, if mitral regurgitation then 1+-4+) Laboratory data: BUN, CR, Na+, HgB, BNP, hemoglobin

Demographic Data Age, Sex, Race & ethnic identification, Marital Status, Living situation (alone, with family, with other person), employment status (employed, self-employed, retired, unemployed due to disability), highest level of education, religious affiliation, annual household income, insurance (none, Medicare, Medicaid, Veterans Administration, Kaiser, other Health Maintenance Organization, private fee for service).

Medications & Treatment (Assessed at Enrollment and 1-2 weeks later) Heart Failure medications: ACEI, ARB, β-blocker, digoxin, spironolactone, eplerenone, loop diuretics, nesiritide, inotropes, warfarin Analgesics: NSAIDs, Cox-2 inhibitors, Aspirin, Acetaminophen,

Tramadol, Opioids Antidepressants: SSRI, Tricyclics, Psychostimulants, other Topical agents:

acetylsalicylate acid creams, capsaicin Physical therapy, cold, heat, other modalities Statistical Evaluation We will report frequencies of pain in total, frequencies of levels of severity & interference in activities of pain, by occasional versus frequent or constant pain, and by location with descriptive statistics. To the extent the etiology of pain is identified this will be reported with descriptive statistics. Pearson product-moment correlation coefficients, t-test and frequency statistics (Chi-square and Fisher's Exact test) will be used to evaluate associations between pain presence, severity and type and demographic and clinical variables. If possible, comparison will be made between patients without pain and those with pain using chi-square tests and t-test.

A multivariate analysis of variance will be used to assess relationship between pain and measures of heart failure severity, social support, depression and symptom distress other than pain.

Differences in Pain measures will be assessed between enrollment and the second assessment 1-2 weeks later, and changes will be correlated with changes in treatment for pain. Geographic locations of pain will be mapped using the body diagram on the BPI to identify areas of greatest frequency.

Study Design

Study Type:

Observational

Actual Enrollment :

349 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Investigating Pain in Heart Failure Patients

Study Start Date :

Jun 1, 2006

Actual Primary Completion Date :

Dec 1, 2007

Actual Study Completion Date :

Dec 1, 2007

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Advanced HF (Stage D or advanced Stage C HF) with:

symptoms of dyspnea at rest or with minimal exertion systolic dysfunction or preserved systolic function ("diastolic heart failure") Outpatient care setting (office, clinic or home hospice).

Patient already receiving optimal medical therapy per ACC/AHA guidelines (ACEI or ARB

β-blocker +aldosterone antagonist) for at least 1 month or explanation of intolerance of specific medication. We will exclude those not on optimized medications with no notation of intolerance; however, we will keep a tally to quantify patients who are considered "advanced Heart Failure" but are not on recommended medications.

Can be awaiting LVAD, transplantation or other procedure
Age > 18 years and able to sign informed consent to participate

Exclusion Criteria:

Cognitive or other impairment which prevents accurate assessment of symptoms or ability to provide informed consent.
Heart failure due to recent onset of acute viral myocarditis, peripartum myocarditis.
Patient on hemodialysis or receiving mechanical ventilation
Patients receiving investigational agents or devices.
Patients who have received heart transplant or a destination Left Ventricular Assist Device

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	San Diego Hospice & Palliative Care	San Diego	California	United States	92103
2	Washington DC VAMC Heart Failure Clinic	Washington	District of Columbia	United States	20017
3	Hospice of Palm Beach County	Palm Beach	Florida	United States	33407
4	Lifepath Hospice & Palliative care	Tampa	Florida	United States	33609
5	Bluhm Cardiovascular Institute	Chicago	Illinois	United States	60611
6	Unniversity of Kentucky	Lexington	Kentucky	United States	40536
7	Kaiser Mid-Atlantic States	Silver Spring	Maryland	United States	20910
8	Singing River Hospital System	Pascagoula	Mississippi	United States	39581
9	Strong Memorial Congestive Heart Failure Program	Rochester	New York	United States	14642
10	Cleveland Clinic Foundation	Cleveland	Ohio	United States	44193
11	Hospice of Lancaster County/The Heart Group	Lancaster	Pennsylvania	United States	17604
12	Caris Health Care	Knoxville	Tennessee	United States	37923
13	The Heart Center	Holladay	Utah	United States	84124
14	Capital Hospice	Falls Church	Virginia	United States	22042