Is treatment outcome improved if patients match themselves to treatment options?

Study protocol for a randomized controlled trial

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

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Resumé

BACKGROUND: Research on matching patients to treatment has shown that matching grounded in expert views is little better than allocating patients by chance. Furthermore, there is growing emphasis on involving patients in their own treatment as a key to health behavior change. Research on the benefit of having patients choose their treatment from among options, in contrast to being assigned to a treatment by experts, has been limited. Consequently, we designed a rigorous test of patient self-matching to determine whether it does improve retention, adherence, and outcome in alcoholism treatment.

METHODS/DESIGN: The present study is being conducted as a randomized controlled trial. Four hundred consecutive patients aged 18 years or older will be enrolled and randomized to either self-matching or expert-matching to one of five different treatment approaches. All patients entering the alcohol outpatient clinic in Odense are offered the opportunity to participate in the study. Exclusion criteria are cognitive dysfunction as measured with the Mini Mental State Examination, and non-Danish- or non-English-speaking individuals. The following instruments will be administered at intake to provide standardized measures of alcohol problems: the Addiction Severity Index, Timeline Followback, the World Health Organization quality of life questionnaire, the NEO Five-Factor Inventory 3, and the Personal Happiness Form. For each outcome measure, two analyses will be conducted. Intention-to-treat analyses (ITT) will be carried out with all patients, regardless of whether they complete the interventions or are reinterviewed. Regarding incomplete data, multiple imputations will be used together with ITT analysis. Completer analyses will also be carried out with patients who complete their respective interventions. The primary outcome is decrease in number of monthly excessive drinking days 6 months after initiation of treatment. Secondary outcomes are compliance and 2 quality of life. The influence of personality traits on outcome will also be examined in both groups.

DISCUSSION: The debate on matching patients to treatment has been going on for decades. This study will cast light on this issue by focusing on patients' choice and thereby clarifying if patients' perceived autonomy yields better outcomes.

TRIAL REGISTRATION: ClinicalTrials.gov, NCT03278821 . Registered on 12 September 2017.

OriginalsprogEngelsk
Artikelnummer219
TidsskriftTrials
Vol/bind19
Antal sider9
ISSN1745-6215
DOI
StatusUdgivet - 6. apr. 2018

Fingeraftryk

Randomized Controlled Trials
Intention to Treat Analysis
Alcoholism
Quality of Life
Happiness
Health Behavior
Ambulatory Care Facilities
Research
Drinking
Compliance
Alcohols
Outcome Assessment (Health Care)
Equipment and Supplies

Citer dette

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title = "Is treatment outcome improved if patients match themselves to treatment options?: Study protocol for a randomized controlled trial",
abstract = "BACKGROUND: Research on matching patients to treatment has shown that matching grounded in expert views is little better than allocating patients by chance. Furthermore, there is growing emphasis on involving patients in their own treatment as a key to health behavior change. Research on the benefit of having patients choose their treatment from among options, in contrast to being assigned to a treatment by experts, has been limited. Consequently, we designed a rigorous test of patient self-matching to determine whether it does improve retention, adherence, and outcome in alcoholism treatment.METHODS/DESIGN: The present study is being conducted as a randomized controlled trial. Four hundred consecutive patients aged 18 years or older will be enrolled and randomized to either self-matching or expert-matching to one of five different treatment approaches. All patients entering the alcohol outpatient clinic in Odense are offered the opportunity to participate in the study. Exclusion criteria are cognitive dysfunction as measured with the Mini Mental State Examination, and non-Danish- or non-English-speaking individuals. The following instruments will be administered at intake to provide standardized measures of alcohol problems: the Addiction Severity Index, Timeline Followback, the World Health Organization quality of life questionnaire, the NEO Five-Factor Inventory 3, and the Personal Happiness Form. For each outcome measure, two analyses will be conducted. Intention-to-treat analyses (ITT) will be carried out with all patients, regardless of whether they complete the interventions or are reinterviewed. Regarding incomplete data, multiple imputations will be used together with ITT analysis. Completer analyses will also be carried out with patients who complete their respective interventions. The primary outcome is decrease in number of monthly excessive drinking days 6 months after initiation of treatment. Secondary outcomes are compliance and 2 quality of life. The influence of personality traits on outcome will also be examined in both groups.DISCUSSION: The debate on matching patients to treatment has been going on for decades. This study will cast light on this issue by focusing on patients' choice and thereby clarifying if patients' perceived autonomy yields better outcomes.TRIAL REGISTRATION: ClinicalTrials.gov, NCT03278821 . Registered on 12 September 2017.",
keywords = "Alcohol addiction, Alcohol treatment, Binge drinking, Informed choice, Randomized controlled trial",
author = "Hell, {Morten Ellegaard} and Miller, {William R} and Bent Nielsen and Nielsen, {Anette S{\o}gaard}",
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Is treatment outcome improved if patients match themselves to treatment options? Study protocol for a randomized controlled trial. / Hell, Morten Ellegaard; Miller, William R; Nielsen, Bent; Nielsen, Anette Søgaard.

I: Trials, Bind 19, 219, 06.04.2018.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

TY - JOUR

T1 - Is treatment outcome improved if patients match themselves to treatment options?

T2 - Study protocol for a randomized controlled trial

AU - Hell, Morten Ellegaard

AU - Miller, William R

AU - Nielsen, Bent

AU - Nielsen, Anette Søgaard

PY - 2018/4/6

Y1 - 2018/4/6

N2 - BACKGROUND: Research on matching patients to treatment has shown that matching grounded in expert views is little better than allocating patients by chance. Furthermore, there is growing emphasis on involving patients in their own treatment as a key to health behavior change. Research on the benefit of having patients choose their treatment from among options, in contrast to being assigned to a treatment by experts, has been limited. Consequently, we designed a rigorous test of patient self-matching to determine whether it does improve retention, adherence, and outcome in alcoholism treatment.METHODS/DESIGN: The present study is being conducted as a randomized controlled trial. Four hundred consecutive patients aged 18 years or older will be enrolled and randomized to either self-matching or expert-matching to one of five different treatment approaches. All patients entering the alcohol outpatient clinic in Odense are offered the opportunity to participate in the study. Exclusion criteria are cognitive dysfunction as measured with the Mini Mental State Examination, and non-Danish- or non-English-speaking individuals. The following instruments will be administered at intake to provide standardized measures of alcohol problems: the Addiction Severity Index, Timeline Followback, the World Health Organization quality of life questionnaire, the NEO Five-Factor Inventory 3, and the Personal Happiness Form. For each outcome measure, two analyses will be conducted. Intention-to-treat analyses (ITT) will be carried out with all patients, regardless of whether they complete the interventions or are reinterviewed. Regarding incomplete data, multiple imputations will be used together with ITT analysis. Completer analyses will also be carried out with patients who complete their respective interventions. The primary outcome is decrease in number of monthly excessive drinking days 6 months after initiation of treatment. Secondary outcomes are compliance and 2 quality of life. The influence of personality traits on outcome will also be examined in both groups.DISCUSSION: The debate on matching patients to treatment has been going on for decades. This study will cast light on this issue by focusing on patients' choice and thereby clarifying if patients' perceived autonomy yields better outcomes.TRIAL REGISTRATION: ClinicalTrials.gov, NCT03278821 . Registered on 12 September 2017.

AB - BACKGROUND: Research on matching patients to treatment has shown that matching grounded in expert views is little better than allocating patients by chance. Furthermore, there is growing emphasis on involving patients in their own treatment as a key to health behavior change. Research on the benefit of having patients choose their treatment from among options, in contrast to being assigned to a treatment by experts, has been limited. Consequently, we designed a rigorous test of patient self-matching to determine whether it does improve retention, adherence, and outcome in alcoholism treatment.METHODS/DESIGN: The present study is being conducted as a randomized controlled trial. Four hundred consecutive patients aged 18 years or older will be enrolled and randomized to either self-matching or expert-matching to one of five different treatment approaches. All patients entering the alcohol outpatient clinic in Odense are offered the opportunity to participate in the study. Exclusion criteria are cognitive dysfunction as measured with the Mini Mental State Examination, and non-Danish- or non-English-speaking individuals. The following instruments will be administered at intake to provide standardized measures of alcohol problems: the Addiction Severity Index, Timeline Followback, the World Health Organization quality of life questionnaire, the NEO Five-Factor Inventory 3, and the Personal Happiness Form. For each outcome measure, two analyses will be conducted. Intention-to-treat analyses (ITT) will be carried out with all patients, regardless of whether they complete the interventions or are reinterviewed. Regarding incomplete data, multiple imputations will be used together with ITT analysis. Completer analyses will also be carried out with patients who complete their respective interventions. The primary outcome is decrease in number of monthly excessive drinking days 6 months after initiation of treatment. Secondary outcomes are compliance and 2 quality of life. The influence of personality traits on outcome will also be examined in both groups.DISCUSSION: The debate on matching patients to treatment has been going on for decades. This study will cast light on this issue by focusing on patients' choice and thereby clarifying if patients' perceived autonomy yields better outcomes.TRIAL REGISTRATION: ClinicalTrials.gov, NCT03278821 . Registered on 12 September 2017.

KW - Alcohol addiction

KW - Alcohol treatment

KW - Binge drinking

KW - Informed choice

KW - Randomized controlled trial

U2 - 10.1186/s13063-018-2592-9

DO - 10.1186/s13063-018-2592-9

M3 - Journal article

VL - 19

JO - Trials

JF - Trials

SN - 1745-6215

M1 - 219

ER -