Condition category
Respiratory
Date applied
11/01/2018
Date assigned
17/01/2018
Last edited
13/02/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Nearly 17% of adults smoke and tobacco use remains the leading preventable cause of death and illness in the U.S. Smoking kills an estimated 480,000 Americans annually and results in more than $300 billion in direct health care costs and lost productivity each year. Treatment for nicotine dependence is cost-effective and is recommended for all smokers, more than half of whom make an attempt to quit smoking each year. Unfortunately, most smokers fail to utilize evidence-based treatment when trying to quit. Less than one third use a medication approved by the Food and Drug Administration and less than 10% use behavioral treatment. Best practice and clinical guidelines dictate smokers should be offered a combination of these interventions, but less than 6% of smokers utilize this comprehensive care. Thus, improving uptake of evidence-based smoking cessation treatment is an important public health goal. Health care systems and health insurers are particularly well positioned to support this goal within the patient populations they serve. As such, it is important to evaluate population-level interventions to promote treatment utilization which can be broadly disseminated within these organizations. Therefore, the aim of this study is to see if mailed letters with different information can encourage patients to stop smoking or join a smoking treatment program.

Who can participate?
Adults aged 18 to 60 years old who are smokers/tobacco users.

What does the study involve?
Participants are randomly allocated to one of five groups. Those in the first group receive no letter. Those in the second group receive a referral only letter. Those in the third group receive a health motivation letter. Those in the fourth group receive a money motivation letter and those in the last group receive a personal values motivator letter. Participants receive only one letter and there is not further contact. The amount of participants who enrolled in the smoking treatment program five months after receiving their letter is collected.

What are the possible benefits and risks of participating?
Participants who sought treatment for nicotine dependence, as recommended, could quit smoking, save money, and experience positive health benefits associated with not smoking. There were no known risks to study participation.

Where is the study run from?
Kaiser Permanente Washington (USA)

When is the study starting and how long is it expected to run for?
January 2016 to August 2016

Who is funding the study?
Group Health Foundation (USA)

Who is the main contact?
Dr Jennifer McClure (Scientific)

Trial website

Contact information

Type

Scientific

Primary contact

Dr Jennifer McClure

ORCID ID

http://orcid.org/0000-0002-2094-9147

Contact details

Kaiser Permanente Washington Health Research Institute
1730 Minor Ave
Suite 1600
Seattle
WA
98101
United States of America

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

215146

Study information

Scientific title

Evaluation of a population-level strategy to promote tobacco treatment use among insured smokers: a pragmatic, randomized trial

Acronym

Study hypothesis

1. Proactively mailed letters would encourage greater smoking cessation treatment enrollment than usual care referral strategies (i.e., no letter) among smokers enrolled in a large mixed-model US health plans
2. The impact on future treatment enrollment would vary based on the content in the letters (motivational vs. referral only)
3. The results would differ between people who receive both medical care and coverage from the health plan message source versus those who receive insurance coverage alone

Ethics approval

This work deemed Exempt Research under 45 CFD 46.101(b(4) by the Kaiser Permanente Washington Institutional Review Board and granted a waiver of written consent.

Study design

Pragmatic single-centre randomised parallel trial

Primary study design

Interventional

Secondary study design

Randomised parallel trial

Trial setting

Home

Trial type

Other

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Uptake of services for smoking cessation

Intervention

Within strata defined by age, sex, and coverage plan, selected participants are randomly assigned to one of five treatment conditions in equal proportions: no letter (NL), referral only letter (ROL), health motivation letter (HML), money motivation letter (MML), or personal values motivator letter (VML). Mailed letters are chosen because email addresses are not available for all health plan members and, as a policy, the health plan does not communicate with members via unsecure email.

Each letter is of similar length (one page) and formatting, advised smokers to quit, instructed them how to enroll in the covered treatment program, was signed by a single health plan physician, and printed on health plan letterhead. Three letters include additional brief motivational content, as reflected in each letter name. The motivational themes are chosen to reflect key reasons people quit smoking and are designed to encourage people to consider quitting based on these factors. The HML points out to the positive health benefits of quitting (e.g., to reduce risk of cardiovascular disease, cancer, or oral disease; prevent impotence; improve appearance, etc.) and that it is never too late to quit. The MML points out the amount of money one could save in one month, one year, 5 years, and 10 years if they smoke a pack a day and spend on average $8 per pack. The VML acknowledges that every person has different reasons for wanting to quit, which may include their health, finances, desire to set an example for loved ones, or other reason. Participants are encouraged to think about their own personal reasons for wanting to quit. In accordance with Prospect Theory, which predicts that gain-framed messages will be more influential for changing preventative health behaviors than are loss-framed messages, the motivational letters are written in a gain-framed tone (e.g., quitting smoking can help you stay strong and vibrant, prevent disease, or save money). In contrast, the ROL instructs people how to enroll in the covered treatment program, but did not include gain-framed or motivational content.

Each participant receive a single letter. There is no additional intervention contact.

Intervention type

Other

Phase

Drug names

Primary outcome measures

Enrolment in the covered tobacco cessation program was determined using automated treatment enrolment records assessed during the 5 month period following the letter mail date for each participant

Secondary outcome measures

There are no secondary outcome measures

Overall trial start date

01/01/2016

Overall trial end date

30/08/2016

Reason abandoned

Eligibility

Participant inclusion criteria

1. Health plan members in the integrated group practice division and the health plan network
2. Aged 18 to 60 years old
3. Evidence of tobacco use based on ICD codes (all members) or a smoking flag in their electronic medical record (group practice members only)
4. Had not enrolled in the health plan’s covered comprehensive smoking cessation program in the prior year

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

5,000

Participant exclusion criteria

1. No evidence of recent smoking in their medical records based on ICD codes or other tobacco status flags
2. Enrolled in the covered smoking cessation program in the prior year
3. Dis-enrolled from the health plan at the time the intervention letters were mailed

Recruitment start date

03/02/2016

Recruitment end date

04/05/2016

Locations

Countries of recruitment

United States of America

Trial participating centre

Kaiser Permanente Washington
Seattle, Washington
98101
United States of America

Sponsor information

Organisation

Kaiser Permanente Washington Health Research Institute

Sponsor details

1730 Minor Ave
Suite 1600
Seattle
WA
98101
United States of America

Sponsor type

Research organisation

Website

Funders

Funder type

Charity

Funder name

Group Health Foundation

Alternative name(s)

GHF

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

United States of America

Results and Publications

Publication and dissemination plan

Planned publication in an open-access, peer-reviewed, public health journal.

IPD sharing statement:
Participant level data will not be made publically available because we do not have consent to share this information. Moreover, only limited participant level data were collected for this pragmatic trial (e.g., participant identity, age, gender, smoking status, health plan details, and whether they enrolled in the covered smoking cessation program), so this data has little utility for other research purposes.

Intention to publish date

28/02/2018

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/29422026

Publication citations

Additional files

Editorial Notes

13/02/2018: Publication reference added.