Higginson, I.J., Bausewein, C., Reilly, C.C., Gao, W., Gysels, M., Dzingina, M., . . . Moxham, J. (2014). An integrated palliative and respiratory care service for patients with advanced disease and refractory breathlessness: A randomised controlled trial. The Lancet. Respiratory Medicine, 2, 979–987. 

DOI Link

Study Purpose

To assess the effectiveness of a short-term breathlessness support service in facilitating breathlessness mastery in patients with advanced disease

Intervention Characteristics/Basic Study Process

Participants were randomly assigned at a 1:1 ratio by a computer-based system to the intervention group (immediate access to the breathlessness support service plus standard care) or the control group (standard best practice and access to the breathlessness service after six weeks). 
 
The breathlessness support service was an integrative, multidisciplinary service that included respiratory therapy, physiotherapy, occupational therapy, and palliative care. Starting with an outpatient clinic visit to respiratory medicine and palliative care, the present treatment and concerns were assessed, and patients were given a breathlessness pack that included information, management and pacing guidance, a hand-held fan or water spray, and a breath mantra or poem (to facilitate relaxation during crises). Two to three weeks after the clinic visit, a home assessment was performed by a physiotherapist or occupational therapist to determine the need for walking, home aids, reinforcement of self-management, other exercises, and a DVD when appropriate. Patients were then seen at a final clinic visit with a palliative care specialist four weeks following the first visit to determine additional interventions and discharge. 
 
Patients in the control group continued to receive optimum management according to United Kingdom best practice guidelines. After the six-week research interview, these patients were then offered the breathlessness support service. 

Sample Characteristics

  • N = 105 (53 assigned to the breathlessness support service, and 52 assigned to the standard care group)  
  • AVERAGE AGE = 67 years
  • MALES: 58%, FEMALES: 42%
  • KEY DISEASE CHARACTERISTICS: Patients were included if they experienced refractory breathlessness on exertion or rest despite optimum treatment of their underlying disease; advanced diseases including cancer, chronic obstructive pulmonary disease (COPD), chronic heart failure, interstitial lung disease, and motor neuron disease were included; willing to participate in home physiotherapy and occupational therapy; able to provide informed consent
  • OTHER KEY SAMPLE CHARACTERISTICS: Patients were excluded if they experienced breathlessness of unknown etiology, had a primary diagnosis of chronic hyperventilation syndrome, were completely homebound despite the offer of free clinic transport, or were within two weeks of treatment for an acute exacerbation.

Setting

  • SITE: Multi-site    
  • SETTING TYPE: Multiple settings    
  • LOCATION: South London

Phase of Care and Clinical Applications

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

Study Design

This was a single-blinded, randomized, controlled trial. Research nurses and interviewers were blinded to the treatment allocation. Participants, the trial coordinator, and the trial administrator were aware of the treatment allocation.

Measurement Instruments/Methods

  • Chronic Respiratory Disease Questionnaire (CRDQ)
  • London Chest Activity of Daily Living (LCADL) scale
  • EQ-5D and EQ Visual Analog Scale (VAS)
  • Palliative Care Outcome Scale (PCOS)
  • Hospital Anxiety and Depression Scale (HADS)
  • Spirometry to assess pulmonary function
  • Pulse oximetry to assess oxygen saturation
  • Severity of breathlessness in the previous 24 hours on a numeric scale (0–10)

Results

According to the authors, participants who received the integrative palliative and respiratory support service experienced a 16% improvement in breathlessness mastery at week 6 when compared to the standard care group (p = 0.048; effect size of 0.44). 
 
There were no differences in patient-reported secondary outcomes between study groups at six weeks. However, for all measured items except anxiety, the breathlessness support service group had better scores than the control group. Significant improvements in the breathlessness support service group between baseline and six weeks were observed in seven outcomes: mastery, total quality of life score, dyspnea, emotion, average breathlessness per 24 hours, exertional breathlessness per 24 hours, and palliative care outcome scale total scores.
 
The control group demonstrated improvement in only the palliative care outcome scale between baseline and six weeks, and it showed significant deteriorations on the London Chest Activity of Daly Living questionnaire and HADS.
 
Overall, participants in the control group had a poorer survival rate (75%) when compared to participants in the treatment group (95%; p = 0.048). Of the participants with cancer, no significant difference in survival existed among those in the treatment and control arms of the study. However, among the participants without cancer (42), mostly those with COPD and interstitial lung disease, those in the breathlessness support service group were alive through the study to six months. Of the 42 control patients without cancer, 38 were alive at 90 days, and 32 were alive at 180 days. 

Conclusions

An integrative approach to managing breathlessness within a support service improves patient mastery of breathlessness.

Limitations

  • Findings not generalizable
  • Other limitations/explanation: One limitation of the study was a possible placebo effect because participants were not blinded to their specific treatment groups. The authors also suggested that although nurse researchers were blinded to the intervention groups, they may have been able to determine which treatment group participants were assigned based on the existence of breathlessness equipment in their homes (thereby potentially biasing their interviews). In addition, the authors noted that their inclusion and exclusion criteria prevented the inference of study results to patients in the last month of life. Finally, the authors noted that the short-term nature of outcome follow-up restricted their assessment of care costs and long-term survival.

Nursing Implications

Additional research and education on the structure and process of an integrative breathlessness support service for patients with advanced cancer is warranted.