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IIR 10-050 – HSR Study

IIR 10-050
Outlook: An Intervention to Improve Quality of Life in Serious Illness Study
Karen E Steinhauser, PhD
Durham VA Medical Center, Durham, NC
Durham, NC
Funding Period: May 2010 - April 2014
The VHA's commitment to provide quality care through the entire spectrum of veteran's lives requires empirically tested interventions to improve care for veterans with life-limiting illness. Significant effort has focused on improving pain and symptom control. However, less is known about effective ways to address other elements of the patient's experience. The 2005 National Consensus Project on Quality Palliative Care called for increased efforts to conduct and evaluate interventions to address the patients' existential needs. Additionally, VHA guidelines recommend that palliative care should include issues such as spiritual support, an opportunity to say goodbye, life review, and the opportunity to engage in life closure.

The primary objective of the study was to determine whether a brief, portable, non-physician implemented intervention to address existential needs (including preparation, completion, life review) reduces whole person suffering, anxiety and depression, and improves quality of life for veterans with life-limiting illness.

A total of 221 patients were randomly enrolled into one of three study arms to evaluate the effects of discussions of preparation and completion on health outcomes. Participants completed a baseline assessment and were randomly assigned into one of three groups. Subjects in the intervention arm (Outlook) met with the intervention facilitator three times over a period of one month and discussed issues related to life review, issues of forgiveness, heritage and legacy. Participants in the second, attention control, arm (relaxation) also met with a facilitator three times over one month and listened to a non-guided relaxation CD. The third group (usual care) received no study intervention. All participants completed assessments at baseline and five and seven weeks post-baseline, with a sub-set completing one evaluation interview. Study measures included quality of life (QUAL-E and FACIT), anxiety (POMS) depression (brief CES-D), and spiritual well-being (FACIT-sp). Demographics, physical function (ADLS ) and spirituality (Daily Spiritual Experience Scale) were collected at baseline only. Eligible patients had life-limiting illness as determined by clinical criteria indicative of advanced cancer, congestive heart failure (CHF), chronic obstructive pulmonary disease (COPD), end stage renal disease (ESRD or end stage liver disease (ESLD,) but not hospice eligibility. Participants were English speaking, without severe mental illness, and lived within approximately 35 miles of the Durham VAMC.

440 eligible patients were approached for study participation; 179 refused and 261 consented to participation (59% enrollment rate). Following consent, an additional 24 dropped out due to death, lost to follow up, inability to contact, or removal for ineligibility (n=16). 221 veterans were randomized into the three groups described above: Outlook intervention (n=75), attention control, relaxation (n=74) and usual care (n=72). Of those, 182 (82%) completed the first post-assessment, 185 (84%) the second post-assessment. Reasons for attrition included death (n=9), drop-out (n=6), and unable to contact interview window (n=21).
Study participants' average age was 67.8; 96% were male. 46% had cancer, 33% COPD, 13.6% CHF, 6.8% ESRD and .5% ESLD. A majority were married (58.4%); 27.1% were divorced; 7.2% widowed; and 7.2% never married. The study reflected the racial diversity of the geographic area with 52.9% Caucasian and 43.9% African-American; 1.4% identifying as Latino. Participants had a range of educational backgrounds: 9.5% had less than a high school degree, 36% a HS degree or GED, 38% some college or trade school, 9.5% a college degree and 7.2% graduate or professional education. 93.1% were Christian. Participants spanned a spectrum of financial statuses: 16.3% had difficulty paying the bills, 26.2% could pay bills with little left over, 32.6% had little spare money left for special things, and 24.9% had money for extra things. A majority were not employed: 57% were retired, 27.6% were on disability, and 8.6% were otherwise unemployed. As compared with the relaxation arm, intervention participants were more likely to be male, have COPD, be African-American, and say that faith was important.
We compared change in outcome measures over time between the intervention and both the relaxation group and usual care. As compared with usual care, Outlook intervention participants had higher preparation (p<.04) at the first post-assessment and not the second, and improved social well-being second post-assessment (p<.05). As compared with relaxation, Outlook intervention participants did not have significant differences over time in preparation, completion, overall quality of life, anxiety or depression. We conducted sub-analyses to examine the intervention effects for those who were experiencing distress (depression, anxiety, low sense of peace) at baseline, and those with cancer versus other diagnoses. Veteran participants with cancer and those with low sense of peace had improved levels of preparation (p<.04; p<.02) at the first follow up assessment and not the second, as compared with usual care. Veterans with symptoms of depression had higher QOL at the first assessment (p=.05), following the intervention, as compared with relaxation participation. During relaxation sessions, veterans frequently spontaneously discussed life review. Qualitative evaluation interviews revealed positive intervention feedback, as an opportunity to share the burden and experience of illness and reflect on life choices. Qualitative content analyses of intervention discussions confirmed pilot results of previous patterns of intervention discussion themes.1 Analyses examining narrative content across sessions showed additional themes: Vietnam experience, enduring racial discrimination, and 'things to do differently.' The latter included career and educational missed opportunities and poor health behaviors. Veterans who used alcohol or tobacco addictively were more likely to express self-blame for illness.

The Outlook intervention had an impact on social well-being as compared with usual care. The lack of impact on preparation, overall quality of life and anxiety and depression differed from pilot results and suggests serious illness versus hospice populations may have distinct needs.1 Outlook content may benefit from a pairing with cognitive behavioral techniques found to be affective in anxiety and depression treatment.2,3 Relaxation, found to be beneficial in other studies, was not a neutral comparison. Qualitative content showed the unique needs veteran exposed to war in Vietnam and racial discrimination. Veterans reported participation was beneficial; enrollment and completion rates were excellent.4,5

External Links for this Project

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Journal Articles

  1. Steinhauser KE, Alexander S, Olsen MK, Stechuchak KM, Zervakis J, Ammarell N, Byock I, Tulsky JA. Addressing Patient Emotional and Existential Needs During Serious Illness: Results of the Outlook Randomized Controlled Trial. Journal of pain and symptom management. 2017 Dec 1; 54(6):898-908. [view]
  2. Steinhauser KE, Stechuchak KM, Ramos K, Winger J, Tulsky JA, Olsen MK. Current measures of distress may not account for what's most important in existential care interventions: Results of the outlook trial. Palliative & supportive care. 2020 Dec 1; 18(6):648-657. [view]
  3. Steinhauser KE, Voils CI, Bosworth H, Tulsky JA. What constitutes quality of family experience at the end of life? Perspectives from family members of patients who died in the hospital. Palliative & supportive care. 2015 Aug 1; 13(4):945-52. [view]
Conference Presentations

  1. Sautter J, Burton A, Tulsky JA, Olsen MK, Lindquist JH, Hays JC, Zimmerman S, Steinhauser KE. Burden and Well-being among a diverse sample of cancer, CHF, and COPD caregivers. Poster session presented at: National Institute of Nursing Research Scientific Symposium; 2011 Jul 6; Bethesda, MD. [view]
  2. Steinhauser KE, Olsen A, Johnson KS, Ammarell NA, Sanders L, Olsen MK, Groehsoehme D. Caregiver Outlook: Acceptability and Feasibility of a Chaplain-led Intervention for Caregivers in Serious Illness. Poster session presented at: American Academy of Hospice and Palliative Medicine Annual Assembly; 2015 Feb 25; Philadelphia, PA. [view]
  3. Steinhauser KE, Hendrix CC, Bailey DE, Olsen M, Stechuchak KM, Tulsky JA. Evaluation of Outlook: A Randomized Control Trial to Improve Quality of Life in Serious Illness. Poster session presented at: American Academy of Hospice and Palliative Medicine Annual Assembly; 2015 Feb 25; Philadelphia, PA. [view]
  4. Chiarochiaro J, Olsen MK, Steinhauser KE, Tulsky JA. ICU Impact On Trajectories of Well-Being In Patients With Advanced Chronic Illness. (Nominated Top Poster). Poster session presented at: American College of Chest Physicians Annual International Scientific Assembly (CHEST); 2011 Oct 12; Honolulu, HI. [view]
  5. Steinhauser KE, Abernathy A, Ferrell B. Rounding with the Stars: Recruiting and Retaining Patients and Caregivers in Palliative Randomized Control Trials. Paper presented at: American Academy of Hospice and Palliative Medicine Annual Assembly; 2011 Jun 18; Chicago, IL. [view]

DRA: Mental, Cognitive and Behavioral Disorders, Aging, Older Veterans' Health and Care
DRE: Treatment - Observational
Keywords: none
MeSH Terms: none

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