Trial Outcomes & Findings for Improving Symptoms and Quality of Life in Chronic Heart Failure: Pilot Study (NCT NCT01581008)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

31 participants

Primary outcome timeframe

3 months

Results posted on

2018-08-31

Participant Flow

One participant was a screen failure, thus 30 patients completed baseline surveys and were randomized.

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	17	13
Overall Study COMPLETED	16	7
Overall Study NOT COMPLETED	1	6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Improving Symptoms and Quality of Life in Chronic Heart Failure: Pilot Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CASA n=17 Participants 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.	Psychospiritual n=13 Participants 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.	Total n=30 Participants Total of all reporting groups
Age, Continuous	63 years n=5 Participants	65 years n=7 Participants	63 years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants	13 Participants n=7 Participants	30 Participants n=5 Participants
Region of Enrollment United States	17 participants n=5 Participants	13 participants n=7 Participants	30 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	CASA n=17 Participants 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.	Psychospiritual n=13 Participants 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.
Cohort Retention	16 participants	7 participants

SECONDARY outcome

Timeframe: 3 months

Population: This analysis was only conducted in CASA participants

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?"

Outcome measures

Outcome measures
Measure	CASA n=17 Participants 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.	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.
Was Depression Addressed? Baseline PHQ9 score >=10	4 participants	—
Was Depression Addressed? PHQ9 score >=10 addressed w/ treatment plan	4 participants	—
Was Depression Addressed? Baseline PHQ9 suicidal item >=1	2 participants	—
Was Depression Addressed? PHQ9 suicidal item >=1 addressed w/ treatment plan	2 participants	—

SECONDARY outcome

Timeframe: 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.

The investigators will use a CONSORT diagram to display participant flow, and determine how many of those who were approached enrolled in the trial.

Outcome measures

Outcome measures
Measure	CASA n=72 Participants 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.	Psychospiritual n=72 Participants 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.
Participation Rates	17 participants	13 participants

SECONDARY outcome

Timeframe: 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.

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?

Outcome measures

Outcome measures
Measure	CASA n=17 Participants 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.	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.
Adherence to the Study Protocol (CASA Arm Only)	94 %in arm severe target symptoms addressed	—

Adverse Events

CASA

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Psychospiritual

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

David Bekelman, MD, MPH

VA Eastern Colorado Health Care System

Phone: 720-857-5088

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place