| Literature DB >> 31899529 |
Valerie G Press1, Vineet M Arora1, Colleen A Kelly2, Kyle A Carey3, Steve R White3, Wen Wan1.
Abstract
Importance: Many patients who are hospitalized cannot use inhalers correctly, yet education for their use is often not provided. To address the need for an effective intervention feasible for wide-scale implementation, a virtual teach-to-goal intervention was developed to provide tailored patient-directed education using adaptive learning technology. Objective: To assess whether the virtual teach-to-goal intervention is noninferior to an in-person teach-to-goal intervention for improving inhaler technique. Design, Setting, and Participants: An equivalence and noninferiority randomized clinical trial took place from January 13, 2016, through September 20, 2017, with analyses conducted between October 25, 2017, and September 23, 2019. Adult inpatients with asthma or chronic obstructive pulmonary disease (COPD) admitted to general inpatient wards were eligible. Enrolled participants were randomized to virtual (n = 61) or in-person (n = 60) educational interventions. Investigators and research assistants were masked to interventions. Initial enrollment, study assessments, and delivery of the educational intervention occurred in the hospital; participants returned at 30 days for a follow-up research visit. Interventions: Virtual education was a module delivered via handheld tablet with self-assessment questions before demonstration, narrated video demonstration of the correct technique, and self-assessment questions after demonstration; up to 3 rounds were repeated as needed. In-person education participants received iterative rounds of inhaler technique assessment and education by trained staff. Main Outcomes and Measures: Noninferiority testing of whether virtual vs in-person education achieved an equal percentage with correct inhaler technique after education (>9 of 12 steps correct) against an a priori noninferiority limit of -10%; logistic regression models were used to adjust for differences in baseline technique and health literacy.Entities:
Mesh:
Year: 2020 PMID: 31899529 PMCID: PMC6991242 DOI: 10.1001/jamanetworkopen.2019.18205
Source DB: PubMed Journal: JAMA Netw Open ISSN: 2574-3805
Figure 1. Flowchart of Patients Through the Trial
COPD indicates chronic obstructive pulmonary disease; MDI, metered dose inhaler; TTG, teach-to-goal; V-TTG, virtual teach-to-goal.
aMay add to more than 1034 persons because of multiple exclusion factors.
Participant Characteristics
| Characteristic | Total Participants (N = 118) | In-Person TTG Group (n = 59) | Virtual TTG Group (n = 59) |
|---|---|---|---|
| Age, mean (SD), y | 54.5 (13.0) | 53.9 (12.2) | 55.1 (13.7) |
| COPD, No. (%) | 69 (59) | 34 (58) | 35 (59) |
| Female, No. (%) | 76 (64) | 41 (70) | 35 (64) |
| Race/ethnicity, No. (%) | |||
| Black | 114 (97) | 58 (98) | 56 (95) |
| Non-Hispanic or Latino | 103 (100) | 52 (100) | 51 (100) |
| At least high school graduate, No. (%) | 82 (71) | 45 (78) | 37 (65) |
| Adequate health literacy, No. (%) | 87 (74) | 44 (76) | 43 (73) |
| Visited a health care clinician for asthma or COPD care, No. (%) | 74 (63) | 33 (56) | 41 (70) |
| Hospitalized in the previous 12 mo ≥1 time, No. (%) | 73 (62) | 35 (59) | 38 (64) |
| Near-fatal respiratory event ≥1 time, No. (%) | 67 (57) | 30 (50) | 37 (63) |
| % FEV1 predicted, mean (SD) | 1.32 (0.6) | 1.28 (0.7) | 1.37 (0.5) |
| FVC, mean (SD), L/s | 1.95 (0.7) | 1.91 (0.7) | 2.0 (0.6) |
| FEV1:FVC, mean (SD), L/s | 0.67 (0.2) | 0.66 (0.2) | 0.68 (0.1) |
| Baseline level of use, No. (%) | |||
| Correct use | 11 (9) | 10 (17) | 1 (2) |
| Mastery | 0 | 0 | 0 |
Abbreviations: COPD, chronic obstructive pulmonary disease; FEV1, forced expiratory volume in the first second of expiration; FVC, forced vital capacity; TTG, teach-to-goal.
The intervention cohort (virtual TTG) had a higher proportion of baseline misuse compared with the comparator cohort (in-person TTG): P = .008 by a Fisher exact test; all other characteristics by either Fisher exact test or Wilcoxon rank sum test had P ≥ .15.
Near-fatal events defined as ever having been intubated and/or admitted to an intensive care unit.[11]
Lung function data missing (available for 55 participants).
Figure 2. Metered Dose Inhaler Technique Steps Correct Before and After Education
TTG indicates teach-to-goal; V-TTG, virtual teach-to-goal.
Estimated Percentage of Patients With Correct Inhaler Technique by Intervention Group
| Event | In-Person TTG Group | Virtual TTG Group | Difference (SE), % | 95% CI Lower Bound, % |
|---|---|---|---|---|
| Observations, No. | 59 | 59 | NA | NA |
| Observed, % | 83 | 69 | −14 (8) | −26 |
| Marginal, % | ||||
| Model 1 | 82 | 71 | −10 (7) | −22 |
| Model 2 | 82 | 72 | −10 (7) | −22 |
| Model 3 | 81 | 70 | −11 (5) | −19 |
| Observations, No. | 51 | 49 | NA | NA |
| Observed, % | 63 | 53 | −10 (10) | −26 |
| Marginal, % | ||||
| Model 1 | 61 | 55 | −6 (9) | −21 |
| Model 2 | 60 | 56 | −4 (9) | −18 |
| Model 3 | 64 | 52 | −12 (7) | −23 |
Abbreviations: NA, not applicable; TTG, teach-to-goal.
Correct inhaler score equals at least 10 of 12.
Estimated by setting all observations to in-person TTG (or virtual TTG) and averaging estimated percentages over the observed sample. Model 1 represents logistic regression adjusting for baseline score, model 2 represents logistic regression adjusting for baseline score and health literacy (binary indicator for low literacy), and model 3 represents ordinal logistic regression of score (range, 1-12) adjusting for baseline score and health literacy.
Estimated Coefficients From Mixed-Effects Ordinal Logit Model
| Covariate | Estimate (95% CI) | |
|---|---|---|
| Intervention, virtual vs in-person TTG | −0.66 (−1.56 to 0.24) | .15 |
| After intervention, discharge or 30 d | 5.66 (4.69 to 6.63) | <.001 |
| 30 d, vs baseline or discharge | −2.19 (−2.90 to −1.33) | <.001 |
| Interaction between intervention and after intervention | −0.65 (−1.63 to 0.33) | .19 |
| Intervention interaction at 30 d | 0.27 (-0.76 to 1.30) | .61 |
| Low health literacy | −1.36 (−2.21 to −0.52) | .001 |
| SD, #, θ | 1.67 (1.31 to 2.13) | <.001 |
Abbreviation: TTG, teach-to-goal.
Equal to 1 after intervention (ie, discharge and 30 days) and 0 at baseline.
Equal to 1 at 30 days and 0 otherwise.
Estimated SD of random intercept.
Likelihood ratio test that variance component is equal to 0, based on a 50:50 mixture of a χ2 distribution with 1 df and a point mass at 0.