Chronic Heart Failure (CHF)
Conditions
Keywords
palliative care, heart failure, delivery of health care
Brief summary
The overall goal of this study is to evaluate the pilot implementation of two palliative care interventions in veterans with chronic heart failure at the Denver VA Medical Center. This is a study of behavioral and care strategy interventions and involves no investigational drugs or devices.
Detailed description
The investigators will examine the feasibility of two palliative care interventions designed to improve different facets of quality of life. Briefly, the two interventions are: 1. A palliative symptom management and psychosocial care intervention named Collaborative Care to Alleviate Symptoms and Adjust to Illness (CASA) that includes 1. evidence-based palliative symptom management of breathlessness, fatigue, and pain, provided by a nurse; 2. a 6-session structured psychosocial care protocol targeting depression and adjustment to illness, supplemented by informal (family) caregiver assessment and support, provided by a social worker or psychologist; and 3. brief weekly team meetings with the nurse, social worker/psychologist and a palliative care specialist, cardiologist, and primary care provider. 2. A psychospiritual intervention that is home-based, self-guided, and requires minimal resources. It will be delivered in written modular form via US Mail along with brief weekly telephone support. The specific aims of the study are to: 1. Examine intervention feasibility and determine preliminary estimates of intervention effect 1. Determine patient participation rates and cohort retention 2. Conduct a preliminary assessment of outcomes by measuring pre-post changes in quality of life, depressive symptoms, health status, life meaning, and spirituality. 2. Obtain qualitative feedback from study participants, the persons providing the intervention, and providers/leaders in primary care, mental health, palliative care, chaplaincy, and hospital operations.
Interventions
OTHERCollaborative Care to Alleviate Symptoms and Adjust to Illness
A palliative symptom management and psychosocial care intervention named Collaborative Care to Alleviate Symptoms and Adjust to Illness (CASA) that includes (a) evidence-based palliative symptom management of breathlessness, fatigue, and pain, provided by a nurse; (b) a 6-session structured psychosocial care protocol targeting depression and adjustment to illness, supplemented by informal (family) caregiver assessment and support, provided by a social worker or psychologist; and (c) brief weekly team meetings with the nurse, social worker/psychologist and a palliative care specialist, cardiologist, and primary care provider.
BEHAVIORALPsychospiritual
A psychospiritual intervention that is home-based, self-guided, and requires minimal resources. It will be delivered in written modular form via US Mail along with brief weekly telephone support.
Sponsors
University of Iowa
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* eligible veterans from the Denver VAMC will have a prior primary discharge diagnosis of heart failure in the last year, * be at least 18 years of age, able to read and understand English, * have consistent access to a telephone * at least one of the following: 1. Kansas City Cardiomyopathy Questionnaire (KCCQ) score less than or equal to 60; 2. a second hospitalization for with a primary discharge diagnosis of heart failure in the last year; 3. taking at least 80 mg oral furosemide (or equivalent) daily in a single or divided dose for at least 2 weeks; 4. BNP greater than or equal to 250 or NT-proBNP greater than or equal to 1000; or 5. estimated creatinine clearance 30-80 mL/min.
Exclusion criteria
* previous diagnosis of dementia; * active substance abuse, defined as an AUDIT-C score greater than 7, two positive responses on substance abuse screening questions, or medical records indicating active substance abuse or dependence; * comorbid metastatic cancer, given the focus on heart failure palliative care; * nursing home resident; and * diagnosis of bipolar disorder or schizophrenia.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cohort Retention | 3 months | Cohort retention will be determined by examining the proportion of patients who complete the final study visit (at 3-month follow-up) over the total number of patients enrolled in the study (including deceased and lost-to-follow-up). Our goal is an 80% retention rate for this pilot study. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Was Depression Addressed? | 3 months | The Patient Health Questionnaire-9 (PHQ-9) rates nine DSM-IV criteria of depression on a 0 (not at all) to 3 (nearly every day) scale. Scale range is 0-27, with depression severity scored: 0-4 (none), 5-9 (mild), 10-14 (moderate), 15-19 (moderately severe), 20-27 (severe). The suicidal item is thoughts that you would be better off dead, or of hurting yourself in some way? |
| Participation Rates | 7 months | The investigators will use a CONSORT diagram to display participant flow, and determine how many of those who were approached enrolled in the trial. |
| Adherence to the Study Protocol (CASA Arm Only) | 3 months | The investigators will calculate percentage adherence to pre-specified tasks on the intervention protocol, such as: * how often is depression addressed with a treatment plan? * how often are care team recommendations placed as orders in the medical record? * how often are orders completed? |
Countries
United States
Participant flow
Pre-assignment details
One participant was a screen failure, thus 30 patients completed baseline surveys and were randomized.
Participants by arm
| Arm | Count |
|---|---|
| CASA A palliative symptom management and psychosocial care intervention named Collaborative Care to Alleviate Symptoms and Adjust to Illness (CASA) that includes (a) evidence-based palliative symptom management of breathlessness, fatigue, and pain, provided by a nurse; (b) a 6-session structured psychosocial care protocol targeting depression and adjustment to illness, supplemented by informal (family) caregiver assessment and support, provided by a social worker or psychologist; and (c) brief weekly team meetings with the nurse, social worker/psychologist and a palliative care specialist, cardiologist, and primary care provider. | 17 |
| Psychospiritual A psychospiritual intervention that is home-based, self-guided, and requires minimal resources. It will be delivered in written modular form via US Mail along with brief weekly telephone support. | 13 |
| Total | 30 |
Baseline characteristics
| Characteristic | CASA | Psychospiritual | Total |
|---|---|---|---|
| Age, Continuous | 63 years | 65 years | 63 years |
| Region of Enrollment United States | 17 participants | 13 participants | 30 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 17 Participants | 13 Participants | 30 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 17 | 0 / 13 |
| serious Total, serious adverse events | 0 / 17 | 0 / 13 |
Outcome results
Primary
Cohort Retention
Cohort retention will be determined by examining the proportion of patients who complete the final study visit (at 3-month follow-up) over the total number of patients enrolled in the study (including deceased and lost-to-follow-up). Our goal is an 80% retention rate for this pilot study.
Time frame: 3 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CASA | Cohort Retention | 16 participants |
| Psychospiritual | Cohort Retention | 7 participants |
Secondary
Adherence to the Study Protocol (CASA Arm Only)
The investigators will calculate percentage adherence to pre-specified tasks on the intervention protocol, such as: * how often is depression addressed with a treatment plan? * how often are care team recommendations placed as orders in the medical record? * how often are orders completed?
Time frame: 3 months
Population: A variety of process information was analyzed. Please see Bekelman DB et al, Feasibility and acceptability of a collaborative care intervention to improve symptoms and quality of life in chronic heart failure: mixed methods pilot trial Journal of Palliative Medicine 2014, PMID 14329424 for details.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CASA | Adherence to the Study Protocol (CASA Arm Only) | 94 %in arm severe target symptoms addressed |
Secondary
Participation Rates
The investigators will use a CONSORT diagram to display participant flow, and determine how many of those who were approached enrolled in the trial.
Time frame: 7 months
Population: The total population approached was 72 people. 31 consented to be randomized for a participate rate of 43%. Of these, one was a screen failure, and 17 and 13 were randomized to arm 1 and arm 2 respectively.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CASA | Participation Rates | 17 participants |
| Psychospiritual | Participation Rates | 13 participants |
Secondary
Was Depression Addressed?
The Patient Health Questionnaire-9 (PHQ-9) rates nine DSM-IV criteria of depression on a 0 (not at all) to 3 (nearly every day) scale. Scale range is 0-27, with depression severity scored: 0-4 (none), 5-9 (mild), 10-14 (moderate), 15-19 (moderately severe), 20-27 (severe). The suicidal item is thoughts that you would be better off dead, or of hurting yourself in some way?
Time frame: 3 months
Population: This analysis was only conducted in CASA participants
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CASA | Was Depression Addressed? | Baseline PHQ9 suicidal item >=1 | 2 participants |
| CASA | Was Depression Addressed? | Baseline PHQ9 score >=10 | 4 participants |
| CASA | Was Depression Addressed? | PHQ9 score >=10 addressed w/ treatment plan | 4 participants |
| CASA | Was Depression Addressed? | PHQ9 suicidal item >=1 addressed w/ treatment plan | 2 participants |