Clustered randomized controlled trial of a clinic-based problem-solving intervention to improve adherence in adolescents with cystic fibrosis

Alexandra L. Quittner, Michelle Eakin, Adrianne N. Alpern, Alana K. Ridge, Katherine A. McLean, Andrew Bilderback, Kristen K. Criado, Shang En Chung, Kristin Riekert

Research output: Contribution to journalArticle

Abstract

Background: In Cystic Fibrosis (CF), adherence to pulmonary medications is about 50% and decreases during adolescence. Effective interventions have not been integrated into CF care. This effectiveness study tested a brief, clinic-based behavioral intervention to improve adherence. Methods: iCARE (I Change Adherence and Raise Expectations) was a pragmatic, clustered, 2-arm randomized controlled trial at 18 CF Centers. 607 adolescents with CF, ages 11–20 years, participated. Centers were randomized to IMPACT (n = 9; 300 adolescents), a brief problem-solving + education intervention, or standard care (SC; n = 9; 307 adolescents). IMPACT was delivered during a regularly scheduled clinic visit by a member of the clinical care team. The primary outcome was composite pulmonary medication possession ratio (cMPR); secondary endpoints were lung function, Body Mass Index percentile, courses of IV antibiotics, and health-related quality of life at 12 months. Results: Effectiveness of the intervention was tested using mixed models, generalized estimating equations comparing IMPACT to SC. Fifty-eight percent of problem-solving sessions targeted barriers to airway clearance, exercise or nutrition, while 18% addressed pulmonary medications. Average intervention fidelity score was 67% (SD = 14%; Range = 25–100%). No significant intervention effects were found for cMPR or any of the secondary outcomes compared to SC. Conclusions: The IMPACT intervention did not improve medication adherence or health outcomes over 12 months. Challenges to implementing the intervention as intended during busy clinic visits were identified. Trial Registry: ClinicalTrials.gov; No.: NCT01232478; URL: www.clinicaltrials.gov.

Original languageEnglish (US)
JournalJournal of Cystic Fibrosis
DOIs
StatePublished - Jan 1 2019

Fingerprint

Cystic Fibrosis
Randomized Controlled Trials
Lung
Ambulatory Care
Medication Adherence
Registries
Body Mass Index
Quality of Life
Exercise
Anti-Bacterial Agents
Education
Health

Keywords

  • Adherence
  • Adolescents
  • Education
  • Problem-solving

ASJC Scopus subject areas

  • Pediatrics, Perinatology, and Child Health
  • Pulmonary and Respiratory Medicine

Cite this

Clustered randomized controlled trial of a clinic-based problem-solving intervention to improve adherence in adolescents with cystic fibrosis. / Quittner, Alexandra L.; Eakin, Michelle; Alpern, Adrianne N.; Ridge, Alana K.; McLean, Katherine A.; Bilderback, Andrew; Criado, Kristen K.; Chung, Shang En; Riekert, Kristin.

In: Journal of Cystic Fibrosis, 01.01.2019.

Research output: Contribution to journalArticle

Quittner, Alexandra L. ; Eakin, Michelle ; Alpern, Adrianne N. ; Ridge, Alana K. ; McLean, Katherine A. ; Bilderback, Andrew ; Criado, Kristen K. ; Chung, Shang En ; Riekert, Kristin. / Clustered randomized controlled trial of a clinic-based problem-solving intervention to improve adherence in adolescents with cystic fibrosis. In: Journal of Cystic Fibrosis. 2019.
@article{e5d8e3583ef94479911da7471ea70813,
title = "Clustered randomized controlled trial of a clinic-based problem-solving intervention to improve adherence in adolescents with cystic fibrosis",
abstract = "Background: In Cystic Fibrosis (CF), adherence to pulmonary medications is about 50{\%} and decreases during adolescence. Effective interventions have not been integrated into CF care. This effectiveness study tested a brief, clinic-based behavioral intervention to improve adherence. Methods: iCARE (I Change Adherence and Raise Expectations) was a pragmatic, clustered, 2-arm randomized controlled trial at 18 CF Centers. 607 adolescents with CF, ages 11–20 years, participated. Centers were randomized to IMPACT (n = 9; 300 adolescents), a brief problem-solving + education intervention, or standard care (SC; n = 9; 307 adolescents). IMPACT was delivered during a regularly scheduled clinic visit by a member of the clinical care team. The primary outcome was composite pulmonary medication possession ratio (cMPR); secondary endpoints were lung function, Body Mass Index percentile, courses of IV antibiotics, and health-related quality of life at 12 months. Results: Effectiveness of the intervention was tested using mixed models, generalized estimating equations comparing IMPACT to SC. Fifty-eight percent of problem-solving sessions targeted barriers to airway clearance, exercise or nutrition, while 18{\%} addressed pulmonary medications. Average intervention fidelity score was 67{\%} (SD = 14{\%}; Range = 25–100{\%}). No significant intervention effects were found for cMPR or any of the secondary outcomes compared to SC. Conclusions: The IMPACT intervention did not improve medication adherence or health outcomes over 12 months. Challenges to implementing the intervention as intended during busy clinic visits were identified. Trial Registry: ClinicalTrials.gov; No.: NCT01232478; URL: www.clinicaltrials.gov.",
keywords = "Adherence, Adolescents, Education, Problem-solving",
author = "Quittner, {Alexandra L.} and Michelle Eakin and Alpern, {Adrianne N.} and Ridge, {Alana K.} and McLean, {Katherine A.} and Andrew Bilderback and Criado, {Kristen K.} and Chung, {Shang En} and Kristin Riekert",
year = "2019",
month = "1",
day = "1",
doi = "10.1016/j.jcf.2019.05.004",
language = "English (US)",
journal = "Journal of Cystic Fibrosis",
issn = "1569-1993",
publisher = "Elsevier",

}

TY - JOUR

T1 - Clustered randomized controlled trial of a clinic-based problem-solving intervention to improve adherence in adolescents with cystic fibrosis

AU - Quittner, Alexandra L.

AU - Eakin, Michelle

AU - Alpern, Adrianne N.

AU - Ridge, Alana K.

AU - McLean, Katherine A.

AU - Bilderback, Andrew

AU - Criado, Kristen K.

AU - Chung, Shang En

AU - Riekert, Kristin

PY - 2019/1/1

Y1 - 2019/1/1

N2 - Background: In Cystic Fibrosis (CF), adherence to pulmonary medications is about 50% and decreases during adolescence. Effective interventions have not been integrated into CF care. This effectiveness study tested a brief, clinic-based behavioral intervention to improve adherence. Methods: iCARE (I Change Adherence and Raise Expectations) was a pragmatic, clustered, 2-arm randomized controlled trial at 18 CF Centers. 607 adolescents with CF, ages 11–20 years, participated. Centers were randomized to IMPACT (n = 9; 300 adolescents), a brief problem-solving + education intervention, or standard care (SC; n = 9; 307 adolescents). IMPACT was delivered during a regularly scheduled clinic visit by a member of the clinical care team. The primary outcome was composite pulmonary medication possession ratio (cMPR); secondary endpoints were lung function, Body Mass Index percentile, courses of IV antibiotics, and health-related quality of life at 12 months. Results: Effectiveness of the intervention was tested using mixed models, generalized estimating equations comparing IMPACT to SC. Fifty-eight percent of problem-solving sessions targeted barriers to airway clearance, exercise or nutrition, while 18% addressed pulmonary medications. Average intervention fidelity score was 67% (SD = 14%; Range = 25–100%). No significant intervention effects were found for cMPR or any of the secondary outcomes compared to SC. Conclusions: The IMPACT intervention did not improve medication adherence or health outcomes over 12 months. Challenges to implementing the intervention as intended during busy clinic visits were identified. Trial Registry: ClinicalTrials.gov; No.: NCT01232478; URL: www.clinicaltrials.gov.

AB - Background: In Cystic Fibrosis (CF), adherence to pulmonary medications is about 50% and decreases during adolescence. Effective interventions have not been integrated into CF care. This effectiveness study tested a brief, clinic-based behavioral intervention to improve adherence. Methods: iCARE (I Change Adherence and Raise Expectations) was a pragmatic, clustered, 2-arm randomized controlled trial at 18 CF Centers. 607 adolescents with CF, ages 11–20 years, participated. Centers were randomized to IMPACT (n = 9; 300 adolescents), a brief problem-solving + education intervention, or standard care (SC; n = 9; 307 adolescents). IMPACT was delivered during a regularly scheduled clinic visit by a member of the clinical care team. The primary outcome was composite pulmonary medication possession ratio (cMPR); secondary endpoints were lung function, Body Mass Index percentile, courses of IV antibiotics, and health-related quality of life at 12 months. Results: Effectiveness of the intervention was tested using mixed models, generalized estimating equations comparing IMPACT to SC. Fifty-eight percent of problem-solving sessions targeted barriers to airway clearance, exercise or nutrition, while 18% addressed pulmonary medications. Average intervention fidelity score was 67% (SD = 14%; Range = 25–100%). No significant intervention effects were found for cMPR or any of the secondary outcomes compared to SC. Conclusions: The IMPACT intervention did not improve medication adherence or health outcomes over 12 months. Challenges to implementing the intervention as intended during busy clinic visits were identified. Trial Registry: ClinicalTrials.gov; No.: NCT01232478; URL: www.clinicaltrials.gov.

KW - Adherence

KW - Adolescents

KW - Education

KW - Problem-solving

UR - http://www.scopus.com/inward/record.url?scp=85065579407&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85065579407&partnerID=8YFLogxK

U2 - 10.1016/j.jcf.2019.05.004

DO - 10.1016/j.jcf.2019.05.004

M3 - Article

AN - SCOPUS:85065579407

JO - Journal of Cystic Fibrosis

JF - Journal of Cystic Fibrosis

SN - 1569-1993

ER -