Likely to Be Effective

Decision Support/Decision Aids

for Caregiver Strain and Burden

Decision aids are seen as materials provided to facilitate the individual’s decision-making process through the provision of information and activities to work through the actual decision making process. Decision aids may take a number of different forms such as videos, workbooks, and decision-making tools. Decision support is the use of decision aids and/or counseling interactions to facilitate the decision-making process. Decision support approaches and decision aids have been examined in patients with cancer for their effectiveness related to caregiver strain and patient anxiety and depression.

Research Evidence Summaries

Sulmasy, D.P., Hughes, M.T., Yenokyan, G., Kub, J., Terry, P.B., Astrow, A.B., . . . Nolan, M.T. (2017). The trial of ascertaining individual preferences for loved ones' role in end-of-life decisions (TAILORED) study: A randomized controlled trial to improve surrogate decision making. Journal of Pain and Symptom Management, 54, 455–465.

Study Purpose

To test the effectiveness of a nurse-facilitated discussion intervention between patients and their caregivers (surrogates) about the role patients would prefer their surrogates play when they are unable to make decisions

Intervention Characteristics/Basic Study Process

A nurse-led intervention administered by a nurse to dyads of patients with gastrointestinal (GI) cancer and their caregivers (CGs). The nurse compared a patient and a CG responses on a decisional control preferences (DCP) tool and facilitated a discussion between the two about the role a patient would like the CG to play when a patient becomes unable to make decisions. Patients and their surrogates received a Patient-Loved One Decision Making Handout that reflected a patient’s DCP; they also received the advanced directive information. A follow-up call was made at four weeks in which the nurse encouraged them to discuss the patients’ preferences for involving the surrogate in healthcare decisions. In addition, they were reminded to review the handout. Patients and CGs were surveyed at baseline and at eight (± 2) weeks postintervention. The trial is known as The Trial of Ascertaining Individual Preferences for Loved Ones’ Role in End-of-Life Decisions (TAILORED)

Sample Characteristics

  • N = 137 dyads, 46 of which were patients with GI cancer and their surrogates   
  • AGE: 61.2 for all the dyads.
  • MALES: 57%  
  • FEMALES: 43%
  • CURRENT TREATMENT: Chemotherapy, other
  • KEY DISEASE CHARACTERISTICS: Patients with advanced GI cancers excluding those with isolated hepatic metastasis. The study also included dyads of surrogates and patients who had ALS.
  • OTHER KEY SAMPLE CHARACTERISTICS: Spoke English

Setting

  • SITE: Multi-site. Johns Hopkins GI oncology clinic, GI surgical clinic, and ALS clinic; the GI oncology clinic at the University of Chicago 
  • SETTING TYPE: Multiple settings    
  • LOCATION: United States

Phase of Care and Clinical Applications

  • PHASE OF CARE: End-of-life care
  • APPLICATIONS:  Palliative care

Study Design

Randomized controlled trial

Measurement Instruments/Methods

  • Decision Control Preference Scale-Modified to assess surrogates’ perception of their loved one’s preference for surrogates’ involvement.
  • Horowitz Impact of Events Scale to assess surrogates’ stress
  • Family Decision Making Self-Efficacy scale to assess self-efficacy
  • Zarit-Short Form to assess caregiver burden
  • A single-item question to assess satisfaction

Results

  • Improved patient-surrogate concordance on the DCP scale after intervention, but not statistically significant. Significant increase in likelihood of surrogates endorsing shared decision making in the intervention group from baseline to follow-up (ORadj = 2.05, p = 0.03) as compared to control (ORadj = 1.44, p = 0.28). Increased endorsement of shared decision making from baseline to follow-up in the treatment group (51% from 38%) as compared to control (48% from 40%).
  • Surrogate stress declined significantly from baseline (23.1, SD = 15.8) to follow-up (20.8, SD = 15.3) in the treatment group (p = 0.046). At the eight-week follow-up, the treatment group stress score was 20% lower than that of control (adj ratio of means = 0.8, p = 0.04).
  • No significant change in surrogates self-efficacy or significant difference between treatment and control group
  • Caregiver burden increased from baseline to follow-up in the treatment group (12.5, SD = 6.5, to 14.7, SD = 8.1; p < 0.01).
  • A significantly higher percent of the treatment group (71%) were satisfied than in the control (52%, p = 0.02).

Conclusions

Interventions focusing on improving shared decision-making process (decision control preferences) between patients and their surrogates have favorable effects on surrogate stress and satisfaction. Patients prefer shared decision making over pure substitutive judgment. Although perceived burden increased among the treatment group, they were less stressed and more satisfied. This may suggest that increased burden may not always indicate general deterioration.

Limitations

  • Risk of bias (no blinding)
  • Key sample group differences that could influence results
  • Questionable protocol fidelity
  • Subject withdrawals ≥ 10%
  • The intervention was not described well, how long and whether administered by nurses who were trained in a standardized way or to follow a protocol during the discussion. Patients with ALS and GI cancer were combined so it is not possible to know results just for patients with cancer.

Nursing Implications

Facilitating discussions between patients and caregivers/surrogates about decision-making preferences promotes improvement in certain patients’ and surrogates’ outcomes. These discussions supported with handout are feasible interventions that can be administered by nurses.

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Yun, Y.H., Lee, M.K., Park, S., Lee, J.L., Park, J., Choi, Y.S., . . . Hong, Y.S. (2011). Use of a decision aid to help caregivers discuss terminal disease status with a family member with cancer: A randomized controlled trial. Journal of Clinical Oncology, 29, 4811–4819.

Study Purpose

To test whether a decision aid (DA) consisting of a videotape and workbook focused on explaining how to discuss death with family members is more effective than a videotape and workbook on patient pain control for caregivers of patients with cancer

Intervention Characteristics/Basic Study Process

A computerized random number generator blindly assigned caregivers to either a study treatment arm or a control arm with stratification according to caregiver age and patients’ awareness of their terminal status. The treatment group received a DA consisting of a 20-minute take-home educational DVD and a companion 43-page workbook, Patients Want to Know the Truth, for family members’ disclosure of terminal status to patients intended to facilitate decision making of patient–caregiver dyads. The authors developed and rigorously tested the DA, based on the transtheoretical model, in several earlier studies that appear in refereed journals to support its current study use. The control group received a National Cancer Institute–developed, Korean language DVD of similar length and a 29-page educational booklet developed by the Korean Ministry of Health and Welfare on cancer pain control. Both treatment and control groups were observed and assessed at the same intervals: zero, one, three, and six months.

Sample Characteristics

  • The sample (N = 119) included 63 participants in the intervention group and 56 participants in the control group. 
  • Patient mean age was 61.9 years (SD = 12.9); caregiver mean age was 45.6 years (SD = 11.8).
  • The patient sample was 57.2% male and 42.8% female; the caregiver sample was 33.2% male and 66.8% female.
  • Patients were diagnosed with breast cancer (18.5%), lung cancer (15.1%), terminal stomach cancer (14.6%), colon cancer (12%), liver cancer (7.4%), and “other\" cancers (42.5%).
  • All patients were defined as terminally ill and nonresponsive to conventional cancer therapy.
  • All caregivers were a spouse, parent, or child of the patient, 80% were married, 40% had college education or higher, 69% believed in a religion, and most were urban dwellers who had a monthly household income of $2,000 or more.

Setting

  • Multisite
  • Inpatient and outpatient settings
  • Korea

Phase of Care and Clinical Applications

  • End-of-life phase
  • End-of-life and palliative care; education; quality of life

Study Design

A randomized controlled trial design was used.

Measurement Instruments/Methods

  • Decision Conflict Scale (DCS): Used to assess caregiver perceptions of decisional conflict (uncertainty in making choices, feeling informed, clarity of personal values, and receipt of decision-making support) and satisfaction with choice; five-point Likert scale with 0.90 Cronbach’s alpha; administered to caregivers at zero, one, three, and six months   
  • Hospital Anxiety and Depression Scale (HADS): Used to measure caregiver psychological distress; Cronbach’s alphas for two factors ranged from 0.81 to 0.85; administered to caregivers at zero, one, three, and six months     
  • Caregiver Quality of Life Index–Cancer (CQOL): Used to measure caregiver quality of life with cancer; five-point Likert scale and Cronbach’s alpha of 0.89; administered to caregivers at zero, one, three, and six months
  • Decision Regret Scale (DRS): Used to measure caregiver regret with decision to discuss terminal diagnosis with patient; five-point Likert scale and Cronbach’s alpha of 0.89; administered to caregivers at one, three, and six months

Results

Sociodemographic and clinical characteristics of the treatment and control groups did not differ significantly, nor were there significant between-group differences in baseline DCS, HADS, or CQOL-C scores. By six-month assessment, only 26.8% of the total sample remained. Decisional conflict and satisfaction total score and conflict, uncertainty, and value clarity subscale scores significantly improved from baseline to one month for the treatment group as compared to the control group. Over six months, significant between-group differences continued for the DCS total score (p = 0.40) and subscales for conflict (p = 0.031), uncertainty (p = 0.014), and value clarity (p = 0.039). Depression scores improved significantly more in the treatment group than in the control group, and this was sustained over six months (p = 0.008). In the caregiver groups in which patients knew their terminal diagnosis, at six months, DCS uncertainty and depression scores (p = 0.029 and p = 0.031, respectively) showed significant improvement in the treatment (DA) group as opposed to the control group. In the caregiver groups in which patients did not know their terminal status, only the value clarity and depression subscale scores (p = 0.037 and p = 0.032, respectively) showed significance, with greater improvement in the treatment group at six months.

Conclusions

Theoretically based DAs appear to help caregivers of patients with cancer communicate with terminally patients if trained professionals assist those caregivers in the process of using them. This study found that the use of a DA did not improve the decision to discuss terminal prognosis but did reduce caregivers’ decisional conflict and depression, which is congruent with other literature. The caregivers in the treatment group did not have a decrease in anxiety.

Limitations

  • The sample included Koreans only. The DA needs to be tested with other diverse groups and illness populations. 
  • There was high attrition of the sample over the duration of the study (more than 70% in both the control and intervention groups); hence, this was a low-powered study despite the authors’ early determination of needed sample for statistically significant results.

Nursing Implications

Nurses have a primary role in assisting patients and caregivers in making treatment decisions to improve the quality of decision making for both groups. Helping patients become involved in decision making is an important facet of patient-centered care. Face-to-face discussions among nurses, patients, and caregivers often facilitate family coping when nurses engage in astute assessment and establish a trusting relationship with patients and their caregivers to understand their concerns. Use of DAs may provide an additional way to educate and empower patients and caregivers for difficult conversations, including those surrounding end-of-life prognosis and decisions. Nursing support and conversations about the efficacy of DAs for both patients and caregivers can offer greater insight into needed components of care to meet goals for quality patient and caregiver care during the cancer trajectory.

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