Protocol for a Single-Blind, Randomized, Parallel-Group Study of a Nonpharmacological Integrated Care Intervention to Reduce the Impact of Breathlessness in Patients with Chronic Obstructive Pulmonary Disease

Tracy A Smith; Mary M Roberts; Jin-Gun Cho; Ester Klimkeit; Tim Luckett; Nikki McCaffrey; Adrienne Kirby; John R Wheatley

doi:10.1089/pmr.2020.0081

Protocol for a Single-Blind, Randomized, Parallel-Group Study of a Nonpharmacological Integrated Care Intervention to Reduce the Impact of Breathlessness in Patients with Chronic Obstructive Pulmonary Disease

Palliat Med Rep. 2020 Dec 10;1(1):296-306. doi: 10.1089/pmr.2020.0081. eCollection 2020.

Authors

Tracy A Smith^{1

2}, Mary M Roberts^{1

2

3}, Jin-Gun Cho^{1

2

3}, Ester Klimkeit¹, Tim Luckett⁴, Nikki McCaffrey⁵, Adrienne Kirby⁶, John R Wheatley^{1

2

3}

Affiliations

¹ Department of Respiratory and Sleep Medicine, Westmead Hospital, Wentworthville, New South Wales, Australia.
² Westmead Clinical School, Sydney Medical School, University of Sydney at Westmead Hospital, Wentworthville, New South Wales, Australia.
³ Ludwig Engel Centre for Respiratory Research, The Westmead Institute for Medical Research, Wentworthville, New South Wales, Australia.
⁴ Improving Palliative, Aged, and Chronic Care through Clinical Research and Translation (IMPACCT) Faculty of Health, University of Technology Sydney, Ultimo, New South Wales, Australia.
⁵ Deakin University, School of Health and Social Development, Deakin Health Economics, Institute for Health Transformation, Burwood, Victoria, Australia.
⁶ NHMRC Clinical Trials Centre, University of Sydney, Camperdown, New South Wales, Australia.

Abstract

Background: Patients with chronic obstructive pulmonary disease (COPD) frequently experience breathlessness despite maximal medical therapy. Nonpharmacological management is effective in studies enrolling patients with a variety of respiratory diseases; however, the impact on patients with COPD is unclear. Methods: A protocol for a mixed-methods, single-center, observer-blinded, fast-track randomized-controlled, parallel-group trial comparing an immediate eight-week nonpharmacological Westmead Breathlessness Service (WBS) to a standard care control group is described. Population: At least moderate COPD (FEV1:FVC ≤0.7; FEV1%predicted ≤60%) and persistent disabling breathlessness (modified Medical Research Council ≥2). Intervention: Individualized prescription of nonpharmacological breathlessness interventions, including a handheld fan, breathing techniques, postures to relieve breathlessness, relaxation, nutritional advice, energy conservation, and exercise advice delivered by a team including doctors, nurses, a physiotherapist, an occupational therapist, a dietitian, and speech pathologist. Control: Participants who receive the WBS intervention after an eight-week period while receiving usual care (standard care group). Outcome: Primary outcome-Chronic Respiratory Questionnaire (CRQ) Mastery subscale. Secondary outcomes include numerical rating scale of breathlessness intensity, unpleasantness, and confidence managing breathlessness; quality of life as measured by other CRQ subscales; Hospital Anxiety and Depression Scale score; daily step count; health resource utilization 12 months pre- and postintervention; and cost-effectiveness. Qualitative analysis of participant interviews will provide additional context for interpreting the quantitative results. Discussion: This study aims to establish the efficacy and cost-effectiveness of an eight-week nonpharmacological breathlessness intervention in patients with COPD. Trial Registration: The Australian New Zealand Clinical Trial Registry ACTRN12617000499381 (06/04/17).

Keywords: chronic obstructive pulmonary disease; clinical protocol; dyspnea; randomized-controlled trial.