Evidence map›Paper›PMID 32083219›Full record

ArticleContemporary clinical trials communications2020

Interactive group-based orientation sessions: A method to improve adherence and retention in pragmatic clinical trials.

Meghan Mayhew, Michael C Leo, William M Vollmer, Lynn L DeBar, Michaela Kiernan

Registry-linked trialAbstract read
In one paragraph

Article in Contemporary clinical trials communications, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02113592 (Collaborative Care for Chronic Pain in Primary Care), which is not on this map. Cited by 13 papers.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02113592 nacompletednot on this map

Collaborative Care for Chronic Pain in Primary Care

TypeinterventionalSponsorKaiser PermanenteRan2014 to 2018Enrolled850ConditionsChronic Non-malignant PainArmsInterdisciplinary pain program
3 · Its place in the literature

Who cites it

13 citing papers in PubMed.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors.

Meghan MayhewKaiser Permanente Center for Health Research, Portland, OR, USA.
Michael C LeoKaiser Permanente Center for Health Research, Portland, OR, USA.
William M VollmerKaiser Permanente Center for Health Research, Portland, OR, USA.
Lynn L DeBarKaiser Permanente Washington Health Research Institute, Seattle, WA, USA.
Michaela KiernanStanford Prevention Research Center, Stanford School of Medicine, Stanford, CA, USA.

Funding

PPACT Administrative Supplement for Research on Sleep Disturbances and Impact on Chronic PainUH3NS088731 · NINDS · KAISER FOUNDATION RESEARCH INSTITUTE · PI DEBAR, LYNN L. · 2014 to 2017
$7.7M
Escalating Proportion of Weight-Loss Maintainers Via Modules Prior to Weight LossR01HL128666 · NHLBI · STANFORD UNIVERSITY · PI KIERNAN, MICHAELA · 2015 to 2019
$3.6M
Collaborative Care for Chronic Pain in Primary CareUH2AT007788 · NCCIH · KAISER FOUNDATION RESEARCH INSTITUTE · PI DEBAR, LYNN L. · 2012 to 2012
$818k
NCCIH NIH HHS UH2 AT007788NHLBI NIH HHS R01 HL128666NINDS NIH HHS UH3 NS088731
6 · The paper itself

Abstract

backgroundIntervention adherence and trial retention are challenging for clinical trials testing intensive behavioral interventions. Operational constraints or trial designs may preclude using effective retention strategies such as financial incentives. We examined whether implementing pre-enrollment orientation sessions was associated with higher intervention adherence and retention in a pragmatic clinical trial.

methodsThe trial tested an intensive behavioral intervention for patients with chronic pain on long-term opioids. Orientation sessions were implemented two years into trial recruitment at one site. Held before informed consent and randomization, these mandatory, group-based orientation sessions provided trial specifics, explained research methods principles, and leveraged motivational interviewing techniques. Using a pre-post design and multivariate models, we assessed adherence (number of intervention meetings attended) and retention (completed quarterly pain assessments over 12 months) before (04/2014-12/2015; n = 209) and after (01/2016-02/2017; n = 258) implementation. Also, we evaluated whether session implementation affected the proportion and characteristics of enrolled patients.

resultsAfter implementing orientation sessions, patients had higher intervention adherence than before (M = 7.6, SD = 3.8 vs. M = 5.6, SD = 4.5, respectively; mean difference = 2.0, 95% CI [0.9, 3.2], p = .001), and 2.8 times greater odds of completing quarterly assessments (95% CI [1.3, 5.8], p = .007). Fewer patients enrolled after implementing sessions than before (38.1% vs. 70.8%, 95% CI [26.4, 39.1], p < .001), with no differences in patient characteristics.

conclusionsImplementing orientation sessions during recruitment may be useful for promoting trial adherence and retention. To ensure enrollment goals are met, target population size and barriers affecting patients' ability to attend orientation sessions should be considered, especially for patients with complex medical conditions. CLINICAL TRIALS REGISTRATION NUMBER: NCT02113592.

Indexed as

AdherenceBehavioral interventionOrientation sessionPatient recruitmentPragmatic clinical trialRetention

Identifiers

PMID32083219
PMCPMC7025079

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.