The Supporting Patient Activation in Transition to Home Intervention ([sPATH])

The Supporting Patient Activation in Transition to Home (sPATH) Intervention - a Study Protocol of Randomized Controlled Trial

This study evaluates if motivational interviewing sessions aiming to motivate recently discharged patients with either chronic obstructive pulmonary disease or congestive heart failure to be active in post-discharge self-management can reduce re-hospitalization rates.

Study Overview

• Status: Completed
• Conditions: Heart Failure; Chronic Obstructive Pulmonary Disease; Medication Adherence; Self-care
• Intervention / Treatment: Behavioral: Motivational Interviewing

Detailed Description

Included patients transition to home will be bridged through a telephone-call from a patient activation coach two days post-discharge. The patients will thereafter get motivational interviewing sessions by the same patient activation coach with the the goal that the patients are motivated to the knowledge, skills and confidence needed to manage the four main activity areas: 1) medication management; 2) adhere to care plan/ follow-up visits according to the discharge plan; 3) recognize indications (symptoms/signs) that the condition is worsening and how to respond; and 4) contact and manage relations/encounters with health care providers. Patients in control group will receive standard care, i.e. discharge and follow-up as in normal procedures. The investigators will use a randomization in permuted blocks of 10 intervention patients and 10 control patients included. To test the hypothesis that the re-hospitalizations rate is 15 % lower in the intervention group compared to the control group 242 patients (121 per group) are needed for power of 80% with the level of significance set to 5 % using two-sided chi-square.

• Study Type: Interventional
• Enrollment (Actual): 118
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Huddinge, Sweden
    • Akutkliniken, Karolinska University Hospital
  • Huddinge, Sweden
    • Karolinska Universitetssjukhuset, Lung- Allergikliniken

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients aged 18 years or older with chronic obstructive pulmonary disease or congestive heart failure admitted at a short-term medical ward and who are living in their private home.

Exclusion Criteria:

• Diagnoses of dementia or cognitive impairment, and need of interpreter to participate in conversations.

The exclusion criteria are related to the patients' possibilities to participate in the motivational interviewing sessions by phone.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: Control; Care as usual
EXPERIMENTAL: sPATH; Motivational Interviewing in five sessions post hospital discharge	Behavioral: Motivational Interviewing; Patients will get motivational interviewing sessions by a patient activation coach (medical social workers and/or nurses trained in motivational interviewing and in the intervention) in five post hospital discharge sessions (whereof one face-to-face, four by phone) aiming to increase patient motivation to become active in self-management (medication management, care plan/follow-up, symptoms/signs of worsening condition, contacts with health care provider).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Re-hospitalization	Registry data from the Swedish Register for Health Care Encounters	90 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Healthcare usage	Registry data from the Swedish Register for Health Care Encounters: re-hospitalization at 30 and 180 days. Emergency room and primary care visits at 30, 90 and 180 days	30, 90 and 180 days
Medication adherence	Patient reported data using the Morisky Medication Adherence Scale, 8 items, and registry data using medicine data from the Swedish Prescribed Drug Registry	30, 90 and 180 days
Patient activation	Patient reported data using the Patient Activation Measure, 13 item	30, 90 and 180 days
Health related quality of life	Patient reported data using the EQ-5D-5L	30, 90 and 180 days
Basic Psychological Needs	Patient reported data using the the Basic Psychological Need Satisfaction & Frustration Scale, 18 items	30, 90 and 180 days
Depression	Patient reported data using PHQ-9 (Patient Health Questionnaire)	30, 90 and 180 days

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Collaborators: Forte; Vårdalstiftelsen
• Investigators: Principal Investigator: Mirjam Ekstedt, Professor, LIME, Karolinska Institutet

Publications and helpful links

General Publications

• Brandberg C, Ekstedt M, Flink M. Self-management challenges following hospital discharge for patients with multimorbidity: a longitudinal qualitative study of a motivational interviewing intervention. BMJ Open. 2021 Jul 30;11(7):e046896. doi: 10.1136/bmjopen-2020-046896.
• Flink M, Brandberg C, Ekstedt M. Why patients decline participation in an intervention to reduce re-hospitalization through patient activation: whom are we missing? Trials. 2019 Jan 25;20(1):82. doi: 10.1186/s13063-019-3187-9.
• Flink M, Lindblad M, Frykholm O, Kneck A, Nilsen P, Arestedt K, Ekstedt M. The Supporting Patient Activation in Transition to Home (sPATH) intervention: a study protocol of a randomised controlled trial using motivational interviewing to decrease re-hospitalisation for patients with COPD or heart failure. BMJ Open. 2017 Jul 10;7(7):e014178. doi: 10.1136/bmjopen-2016-014178.

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 1, 2016
• Primary Completion (ACTUAL): June 30, 2018
• Study Completion (ACTUAL): September 1, 2018

Study Registration Dates

• First Submitted: July 1, 2016
• First Submitted That Met QC Criteria: July 5, 2016
• First Posted (ESTIMATE): July 6, 2016

Study Record Updates

• Last Update Posted (ACTUAL): September 23, 2020
• Last Update Submitted That Met QC Criteria: September 20, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: Motivational Interviewing; Symptom management; Empowerment; Medication management; Patient participation; Self determination theory
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: C751231003; Dnr 2014-0026 (OTHER_GRANT: Vårdalsstiftelsen); Dnr 2014-4948 (OTHER_GRANT: Forte)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED